EXPLANATORY STATEMENT

I

The transposition of directives by the European Union is currently one of the priority objectives set by the European Council. The European Commission submits regular reports to the Competitiveness Council, which are given a high political value as they serve to measure the effectiveness and credibility of the Member States in the implementation of the market. internal.

The fulfilment of this objective is even more important today in view of the scenario laid down by the Treaty of Lisbon amending the Treaty on European Union and the Treaty establishing the European Community, for non-compliances of transposition in time, for which the Commission may request the Court of Justice of the European Union to impose significant economic sanctions in an accelerated manner (Article 260.3 of the Treaty on the Functioning of the European Union). European Union -TFEU-).

Spain has consistently met the objectives of the implementation of the deadline, since the beginning of the establishment of the same.

However, during the year 2016, given the prolongation of the situation of the Government in office, the legislative work required by the transposition of these directives into national law could not be carried out in strict compliance with the provisions of Article 21.5 of Law 50/1997 of 27 November of the Government.

The failure to comply with these obligations has negative consequences for our country, which compromise its political credibility and can lead to the imposition of pecuniary fines, based on the provisions of Article 260.3. of the TFEU, so all the necessary resources must be used to avoid such an unfavourable scenario.

In view of the seriousness of the consequences of continuing to accumulate delay in the incorporation into the Spanish legal system of such directives, it is necessary to go to the approval of a Royal Decree-Law to proceed to its transposition, which will allow the closure of the open infringement procedures and thereby prevent the imposition of economic sanctions on Spain.

Regarding the use of Royal Decree-Law as an instrument of transposition, it should be noted that the Constitutional Court, in the judgment 23/1993 of 21 January, points out that the Royal Decree-Law is an instrument It is constitutionally lawful to deal with problematic economic situations, and in its judgment in 1/2012, of 13 January, it endorses the concurrency of the budget enabling the extraordinary and urgent need of article 86.1 of the Constitution when "the patent delay in transposition" and the existence of " procedures for non-compliance against the Kingdom of Spain. ' In the successive paragraphs of this explanatory statement, the reasons for the extraordinary and urgent need to transpose the various directives into each of the assumptions contained in the present Royal will be concretized. Decree-law.

II

In Title I, which encompasses the first and second articles, the regulatory modifications that transpose directives related to the financial system are contained.

The first article of Royal Decree-Law amends Law 41/1999 of 12 November on payment and settlement systems with a double objective: on the one hand, to modify the definition of firmness and irrevocability of the transfer orders in such a way that their determination by the systems can be in accordance with the operating protocols of the pan-European transaction settlement platform TARGET2-Securities, to which the Central bank of Spanish securities in September 2017. Furthermore, the wording of Article 14.1 is amended to adapt the Spanish legislation to the provisions of Article 87 of Regulation (EU) No 648/2012 of the European Parliament and of the Council of 4 July 2012 on derivatives In the case of securities issued by the competent authorities of the European Central Bank, the Commission shall, in accordance with Article 1 (2) of Regulation (European), (2) and (2) of the European Parliament and of the Council of the European Parliament and the Council, securities in insolvency proceedings. It should be noted, in this regard, that Article 87 incorporates the regulation of these effects on guarantees by amending Article 9 of Directive 98 /26/EC of the European Parliament and of the Council of 19 May 1998 on the It is necessary to amend the Law 41/1999 of 12 November before it is necessary to comply properly with our obligations in respect of the application of the law of the European Union.

In relation to the first of the proposed modifications, the definition that the operating protocols of the TARGET2-Securities settlement platform makes of the firmness and the irrevocability of the orders that receives, differs from that set out in our Law 41/1999 of 12 November, applicable to the central depositary of Spanish securities.

The Spanish central securities depository (Iberclear) is due to join TARGET2-Securities in September 2017, so it is urgently necessary to make these adjustments in the wording of the Spanish standard, to ensure in the transition to the new model the full legal certainty of the operations carried out on that platform and which are in line with the provisions of Directive 98 /26/EC. This is in line with the provisions of Article 39 (2) and (3) of Regulation (EU) 909/2014 of the European Parliament and of the Council on the improvement of securities settlement in the European Union and central securities depositories. and amending Directives 98 /26/EC and 2014 /65/EU and Regulation (EU) No 236/2012.

Thus, in 2012, Iberclear made a number of commitments to the Eurosystem with the signing of the TARGET2-Securities Framework Agreement, the pan-European securities settlement platform promoted by the Eurosystem as a private initiative. As agreed by Iberclear, you will need to migrate in the last migration window, on September 18, 2017. Those responsibilities that Iberclear assumed with the signing of the Framework Agreement are based on the assumption that the Spanish regulation supports migration and its rules are in line with both European regulations and the functioning of the platform.

As regards the second of the amendments, it is a matter of completing the adaptation of our legal order to Regulation (EU) No 648/2012 of the European Parliament and of the Council of 4 July 2012 on the OTC derivatives, central counterparties and trade repositories. The deadline for Member States to adopt and publish the measures necessary to comply with these amendments was 17 August 2014. If the measures contained in this Royal Decree-Law were not immediately adopted, the obligations imposed on the Kingdom of Spain as a Member State of the European Union could be infringed. For this purpose, the European Commission initiated the formal infringement procedure on 30 September 2016, by notification of Letter of Formal Notice 2016/2112 and, recently, on 28 April 2017, it has notified Reasoned Opinion, conformity with the provisions of Article 258 of the Treaty on the Functioning of the European Union.

The second article of the Royal Decree-Law amends article 234.2 of the recast text of the Law of the Market of Values, approved by the Royal Legislative Decree 4/2015, of 23 October, to establish the suspension of the exercise the voting rights of the shares of issuers where no acquisitions of significant holdings have been reported. This amendment completes the incorporation into our legal order of Directive 2013 /50/EU of 22 October 2013 amending Directive 2004 /109/EC of the European Parliament and of the Council on the harmonisation of transparency requirements relating to information on issuers whose securities are admitted to trading on a regulated market; Directive 2003 /71/EC of the European Parliament and of the Council on the prospectus to be published in the event of an offer public or admission to securities trading; and Commission Directive 2007 /14/EC for which it is lay down detailed rules for the application of certain provisions of Directive 2004 /109/EC, which expired on 26 November 2015.

The completion, more than one year ago, of the deadline for transposition of Directive 2013 /50/EU of the European Parliament and of the Council of 22 October 2013, together with the need for the competent supervisor to be provided with the instruments necessary for the proper implementation of the provisions contained in the Directive, justifies the extraordinary and urgent need to complete the transposition of the Directive. For this purpose, the European Commission is dealing with a formal infringement procedure on which it has already issued reasoned opinion 2016/0063 of 17 November 2016.

III

Title II, which comprises the third and fourth articles, contains the amendments resulting from the transposition of Directive 2014 /104/EU of the European Parliament and of the Council of 26 November 2014 establishing certain rules governing, by virtue of national law, the actions of damages resulting from infringements of the law of competition of the Member States and of the European Union.

The European Union enacted this directive with the aim of establishing effective procedural mechanisms to make it possible to claim damages caused by infringements of competition law, Since, in the absence of such procedural channels, experience has shown that compliance with the material rules is resent, even in spite of the existence of a specific penalty law.

It lays down rules to remove obstacles to the proper functioning of the exercise of the right to exercise, which guarantee the promotion of real competition in the internal market and protection equivalent throughout the Union for all those who have suffered the injury resulting from the infringement of the competition.

The directive also includes rules governing matters of different nature such as those dealing with procedural matters and others dealing with damage to the effects of due compensation and, finally, the consideration of technological factors.

For this purpose, in the third article, the Law 15/2007 of 3 July of the Defense of Competition is amended, introducing a new Title VI concerning the compensation of damages caused by the restrictive practices of the competence. In the service of the objectives required by Directive 2014 /104/EU, the Spanish legal order is introduced in the Spanish legal order, highlighting among others the responsibility of those who infringe the law of the competition to indemnify the damage caused by the infringement; the right to full compensation for the damage caused by these actions is also stated; or the joint liability of those who have carried out the infringement is provided for in the together, although this general rule is qualified in line with the rules of the directive.

The Royal Decree-Law sets the limitation period of 5 years for the exercise of damages actions, and regulates the quantification of damages as regards the burden of proof-which corresponds to the demand- introducing certain nuances, such as a presumption "iuris tantalum" of damage to the offences described as a cartel, or the possibility of the judges to estimate a certain amount of damage if the existence of the But it was practically impossible or too difficult to quantify precisely.

Finally, the test and quantification of the cost are regulated, as well as certain peculiarities of the actions of damages exercised by plaintiffs located at different levels of the supply chain. All of the above with the clear objective of ensuring that the damages suffered by individuals (whether companies or consumers) as a result of such anti-competitive practices are effectively redress.

By incorporating this new Title VI into Law 15/2007 of 3 July of the Defence of Competition, it is also intended to extend the new rules to complaints of damage caused by infringements of Articles 1 and 2 of the the law which does not affect trade between the Member States of the Union and which, therefore, do not fall within the scope of Articles 101 and 102 of the Treaty on the Functioning of the European Union, not to the acts of unfair competition which for the purpose of distorting competition, it is in the public interest that they have a specific regime in the law 3/1991, of 10 January, of Unfair Competition.

Finally, the Spanish legal order is incorporated into the fourth additional provision of Law 15/2007 of 3 July, a series of definitions contained in Article 2 of Directive 2014 /104/EU of the European Parliament and of the European Parliament and of the European Parliament. the Council of 26 November 2014 in order to allow a better understanding of the other provisions of that law. Such incorporation includes legal institutions that are currently non-existent in the Spanish order, such as the transaction requests defined in the said additional provision, referring to the procedure provided for in the Communication. of the European Commission on the development of transaction procedures with a view to the adoption of decisions pursuant to Articles 7 and 23 of Council Regulation (EC) No 1/2003 on cartel cases (2008/C 167/01, OJ L 2, 2008) and similar regulations in other Member States of the Union. The inclusion of such definitions also facilitates the interposition before Spanish courts of damages arising from sanctions decisions of the European Commission or other national competition authorities.

Next, with regard to the provisions of the directive to facilitate the testing of damage procedures resulting from the violation of the competition rules, the main objective of the amendment introduced The fourth article of this Royal Decree-Law in Law 1/2000, of January 7, of Civil Procedure, is the achievement of a better protection of the rights of the Justiciables in that field. To this end, the seventh article introduces a regulation on access to the test sources in Law 1/2000 of 7 January, by means of a new Section 1 ("Access to the sources of proof in procedures for the claim of damages"). (a) in Chapter V ("of the test: general provisions") of Title I ("of the provisions common to the declarative processes") of Book II ("of the declarative processes"), in which they are determined, among other extremes, the requirements to request from the court a measure of access to sources of evidence, a An example of the possible measures, as well as the implementation of these measures and the consequences of the obstruction to their practice, always modulated by the principle of proportionality.

With all this, a letter of a legal nature is given to the notion of a source of proof, through which it alludes to every element capable of serving as a basis for the subsequent probative practice at the appropriate procedural moment. The new regulation allows individuals in the field of competition law to have knowledge of the elements that will serve them in order to try to form the judicial conviction according to the ordinary rules in the field of competition law. Proposal and practice of the test; now, and precisely for this reason, access to test sources does not exempt the litigant from the burden of proposing in time and form the practice of the relevant probative means.

the Royal Decree-Law also refers specifically to access to evidence sources that are held by public administrations and public law entities, for the latter case, the impossibility of access to documentation or material of a reserved or secret nature.

With the aim of ensuring effective access, and in the face of alleged obstruction of access, the standard contains a series of consequences on the effects of the test in the process in question, leaving the the criminal liability in which it may be incurred.

The deadline for transposition into the Spanish legal order of Directive 2014 /104/EU, which ended on 27 December 2016, justifies the use of the Royal Decree-Law as an instrument of transposition. This is the case of extraordinary and urgent need for Article 86 of the Constitution. It is imperative to make the necessary adjustment of our law and to put an end to the delay in fulfilling this obligation, considering the negative consequences that such a delay entails for the citizens, in whose It is appropriate to ensure the effectiveness of the actions for the compensation for damages resulting from infringements of competition law, as for the State, due to the risk of being sanctioned by the institutions of the Union The European Parliament has adopted an infringement procedure which has been initiated by the Commission. European in January 2017.

IV

Title III, which is composed of the fifth article, contains the amendments which incorporate the European Union's internal directives in the field of health. Royal Decree-Law 9/2014 of 4 July 2014 laying down quality and safety standards for the donation, procurement, evaluation, processing, preservation, storage and distribution of human tissues and cells approve the rules for coordination and operation for use in humans, consolidated the transposition into national law of Directive 2004 /23/EC of the European Parliament and of the Council of 31 March 2004 on the establishment of of quality and safety standards for donation, procurement, evaluation, the processing, preservation, storage and distribution of human tissues and cells; Commission Directive 2006 /17/EC of 8 February 2006 implementing Directive 2004 /23/EC of the European Parliament and of the Council on the on certain technical requirements for the donation, procurement and evaluation of human tissues and cells, as well as of Commission Directive 2006 /86/EC of 24 October 2006 implementing Directive 2004 /23/EC of the European Parliament and of the Council on the Parliament and the Council as regards the requirements for traceability, the notification of the reactions and serious adverse effects and certain technical requirements for the coding, processing, preservation, storage and distribution of human tissues and cells.

Following the approval of Royal Decree-Law 9/2014 of 4 July, two Community Directives have been adopted which have introduced new requirements for human tissues and cells to motivate the need for amend the Royal Decree-Law in order to adapt its provisions to those requirements. This is, on the one hand, Commission Directive (EU) 2015/565 of 8 April 2015 amending Directive 2006 /86/EC as regards certain technical requirements for the codification of human tissues and cells; and In the case of the case-law of the Commission, the Court of State held that the Court of State held that the Court of State held that the Court of State held that the Court of State held that the Court of State held that the Court of imported fabrics.

In this way, the traceability of human tissues and cells from the donor to the recipient and vice versa is strengthened. To this end, and as a guarantee of such traceability, certain technical requirements for the coding of human tissues and cells are established.

In particular, the application of the single European code, which provides information on the donation and the product, is guaranteed, attributing to each of these concepts a certain sequence of identification that will be adjusted the format and structure that is set in the rule itself.

For tissues and cells that are excluded or exempted from the application of the single European code, rules are established that guarantee their proper traceability throughout the chain, from donation and procurement to the application in human beings.

And in situations other than the distribution in which the tissues and cells are put into circulation, such as transfer to another operator for subsequent processing, with or without return, the sequence of Identification of the donation should be applied at least in the accompanying documentation.

Tissue establishments, including importing tissue establishments, should correctly apply the requirements of the single European code, with the National Transplant Organisation and the Community (i) the autonomous authorities responsible for monitoring the application. In this way, all approved tissue establishments must have a unique number and will be included in the EU's Fabric Establishment Compendium.

Moreover, with the new regulation introduced in Royal Decree-Law 9/2014 of 4 July, it is required that the imports of cells and tissues be carried out only by tissue establishments approved for this purpose, called importing tissue establishments, except in those cases where the importation of specific cells and tissues, such as for the authorisation of the importation of haematopoietic stem cells, may be authorised directly from bone marrow, peripheral blood or umbilical cord blood used in the treatment of a number of life-threatening diseases.

And in addition, in order to facilitate the distribution within the European Union of imported cells and tissues, even where such distribution is of a cross-border nature, the competent authority should issue the certificate of approval of the establishment of importing tissues.

The obligation to maintain a record of the activities performed by importing tissue establishments, including the types and quantities of imported cells and tissues, as well as their origin and origin, is also established. target.

In any case, importing tissue establishments will have to ensure that the single European code is applied to the imported cells and tissues, either by carrying out this task themselves or by delegating it to the suppliers of third countries, as part of the terms of the written agreements between the two parties.

With regard to the regulatory instrument by which Commission Directive (EU) 2015/565 of 8 April 2015 and Commission Directive (EU) 2015/566 of 8 April 2015 are incorporated into our legal order In 2015, Article 86 of the Constitution states that, in the event of extraordinary and urgent need, the Government may issue provisional legislative provisions that will take the form of decree-laws. In the present case, they are enabling factors for the approval of the legislative amendment which concerns us not only the temporary element, evidenced by the delay in the transposition of both directives, the deadline of which expired on 29 October. in 2016, but also the causal element, given the opening of the infringement proceedings against the Kingdom of Spain on 23 November 2016. Both factors would also have to be added to the material element, reflected in the imperative need to ensure at all times the highest possible level of protection of human health, which in this case requires a uniform application and consistent across the European Union of the traceability of cell and tissue measures, through the immediate implementation of the single European code, and by the need to establish greater controls on the import of tissues and cells, given the gradual increase that the exchanges of the same are experiencing at scale

V

Title IV, composed of the sixth and seventh articles, contains the amendments incorporating into national law a European Union directive on the posting of workers.

Directive 2014 /67/EU of the European Parliament and of the Council of 15 May 2014 on the guarantee of compliance with Directive 96 /71/EC on the posting of workers in the framework of a provision of services, and amending Regulation (EU) No 1024/2012 on administrative cooperation through the Internal Market Information System ('IMI Regulation '), establishes a common framework of provisions, measures and mechanisms of control needed for better and more uniform transposition, implementation and enforcement in the Directive 96 /71/EC of the European Parliament and of the Council of 16 December 1996 on the posting of workers in the framework of the provision of services, including measures to prevent and punish any abuse and circumvention of the applicable rules.

It is intended to ensure that an appropriate level of protection of the rights of posted workers is respected for the provision of cross-border services, in particular that the conditions of employment are met. applicable in Member State where the service is to be provided, in accordance with Article 3 of Directive 96 /71/EC, while facilitating the exercise of the freedom to provide services to providers and promoting a climate of fair competition within the European Union and the European Economic Area.

The Spanish legal system, through Law 45/1999 of 29 November on the posting of workers in the framework of the provision of transnational services, and other legal provisions, anticipates to a large extent the content of Directive 2014 /67/EU. In addition, certain administrative actions have recently been carried out, such as the approval of the Technical Criteria. 97/2016 of the Labour and Social Security Inspectorate on the posting of workers in the framework of the provision of transnational services, or the creation of a single national website within the Portal of the Ministry of Employment and Social security with information, inter alia, on the working conditions applicable to posted workers and the provisions governing them, and on prior communication of travel, including contact details the competent labour authorities by reason of the territory.

However, the transposition of some aspects of Directive 2014 /67/EU requires the approval of a rule with a range of law.

On the one hand, the transposition into Spanish law of Article 9 of the Directive on "Administrative requirements and control measures" which Member States may, where appropriate, impose on the subject covered by the law 45/1999 (Articles 5 "Displacement notice" and 6 "Obligation to appear and provide documentation"). On the other hand, the classification as administrative infractions of the breaches of these new obligations requires the modification of the recast of the Law on Infrastructures and Sanctions in the Social Order approved by the Royal Decree Legislative 5/2000 of 4 August.

In addition, the transposition of Chapter VI of Directive 2014 /67/EU on "Cross-border enforcement of administrative penalties and fines" also requires a rule with a range of law, in this case, by virtue of the a law which derives from the principles of legality and typicality of the administrative offences and penalties laid down in the Spanish Constitution of 1978, as long as the principles of mutual recognition and mutual assistance are applied to cross-border enforcement of administrative sanctions imposed on a service provider established in a Member State of the European Union or the European Economic Area for failure to comply with the rules applicable to the posting of workers in another Member State implies the need for the Spanish authorities to recognize the penalties imposed by the authorities of other States as if they had been imposed by the Spanish authorities themselves in accordance with the Spanish legislation, as well as the implementation of the measures necessary for their notification or collection on Spanish territory.

Directive 2014 /67/EU provides in Article 23 that Member States should bring into force the laws necessary to comply with Directive 2014 /67/EU by 18 June 2016 at the latest.

On 16 February 2017, a reasoned opinion is received from the European Commission pursuant to Article 258 of the Treaty on the Functioning of the European Union for the non-adoption of the national measures for the transposition of the Treaty. Directive on the guarantee of compliance with Directive 96 /71/EC.

The Commission in that reasoned opinion draws the attention of the Government to the financial penalties which the Court of Justice of the European Union may impose under Article 260 (3) of the Treaty on the Functioning of the European Union. the European Union.

Directive 2014 /67/EU is partly incorporated into our legal system, as stated in this Motive Exhibition. However, other measures contained in Directive 2014 /67/EU need to be adopted in order to ensure adequate monitoring of compliance with the obligations laid down in Directive 96 /71/EC and the principle of mutual assistance through the notification and cross-border enforcement of sanctions.

VI

Finally, through the final provision, the recast text of the General Law for the Defense of Consumers and Users and other complementary laws, approved by Royal Legislative Decree 1/2007, of 16 In this case, the temporary and causal elements necessary for its approval are also in this case, since this modification responds to the need to give immediate response to the Pilot Project 8007 /15/JUST opened to the Kingdom of Spain incorrect transposition of Directive 2011 /83/EU of the European Parliament and of the Council Council Directive of 25 October 2011 on consumer rights, amending Council Directive 93 /13/EEC and Directive 1999 /44/EC of the European Parliament and of the Council and repealing Council Directive 85 /577/EEC and the Directive 97 /7/EC of the European Parliament and of the Council, fulfilling the commitments made with the European Commission and avoiding the imposition of possible economic sanctions on the Kingdom of Spain.

The modification of the recast text of the General Law for the Defense of Consumers and Users and other complementary laws has an impact on the necessary protection of consumers in their relations with businessmen, in the specific aspect relating to the means to be used by the employer to repay the payment received from the consumer in the event of withdrawal, ensuring that the latter does not incur any expenditure as a result of the withdrawal of the contract, also the material element which justifies its approval by Royal Decree-Law, if it is taken into account that the deadline for transposition of Directive 2011 /83/EU of the European Parliament and of the Council of 25 October 2011 expired on 13 December 2013.

Therefore, for its purpose and for the context of the temporary exigency in which it is dictated, the circumstances of extraordinary and urgent need are met.

In its virtue, making use of the authorization contained in article 86 of the Spanish Constitution, on the proposal of the Vice President of the Government and Minister of the Presidency and for the Territorial Administrations, of the Minister The Minister for Employment and Social Security, the Minister for Economic Affairs, Industry and Competitiveness, and the Minister for Health, Social Services and Equality, and the Council of Ministers at their meeting on 26 May 2017,

DISPONGO:

TITLE I

Transposition of European Union directives into the financial system

Article first. Amendment of Law 41/1999 of 12 November on payment systems and securities settlement.

Law 41/1999 of 12 November on payment systems and securities settlement is amended as follows:

One. Article 11 is amended to read as follows:

" Article 11. Firmness of the transfer orders.

1. The transfer orders submitted to a system by its participants, once received and accepted in accordance with the rules of operation of the system, the compensation which, where appropriate, takes place between them, the obligations resulting from the such compensation, and those intended to liquidate any other commitments provided by the system to ensure the good end of the accepted transfer orders or the compensation made, shall be firm, binding and legally binding. (a) to be required for the participant obliged to comply with and to be liable to third parties; can be challenged or nullified by any cause.

Transfer orders submitted to a system by its participants may not be revoked by participants or by third parties from the time determined by the system's operating rules.

Each system will determine in its own rules the moments of irrevocability and firmness of the transfer orders, and in the case of interoperable systems, the rules of each of them will ensure, as far as possible coordination with the rules of the other affected systems as regards the determination of such moments. However, unless the rules of all interoperable systems are expressly laid down by each other, the rules of each of them relating to the times of irrevocability and firmness shall not be affected by the rules of each other.

2. The provisions of the above paragraph:

(a) It is without prejudice to any action which may be taken by the body or any creditor to require, where appropriate, the compensation which corresponds, or the responsibilities arising, for a performance contrary to the law, or any other cause, of those who have performed such action or who have been unduly beneficiaries of the operations carried out.

(b) No obligation for the settlement manager or agent to ensure or supplement the lack of cash or securities of a participant for the purposes of the settlement of an order or a clearing, or the an obligation to use in such a means other than those provided for in the rules of operation of the system.

3. The favourable balances resulting from the cash accounts opened in the Banco de España for the settlement of transactions carried out in a system recognised in accordance with the provisions of this Law or by the law of another Member State of The European Union, under Directive 98 /26/EC of the European Parliament and of the Council of 19 May on the determination of settlement in payment and securities settlement systems, shall be affected by the fulfilment of the obligations of the European Union. participating entities in accordance with the rules of operation of the same, not being able to be the object of lien, lien, lien or any other judicial or administrative measure of enforcement, restriction or retention of any kind, until the end of the daily settlement of the relevant system. '

Two. A final paragraph is added to Article 14 (1), which shall be worded as follows:

" 1. The rights of a system manager or a participant in respect of guarantees formed in his favour in a system or in any interoperable system shall not be affected, having an absolute right of separation, by means of insolvency opened against:

a) The participant in the system in question or in an interoperable system,

b) a system manager of an interoperable system that is not a participant,

(c) a counterparty of the central banks of the Member States or of the European Central Bank

or

(d) any third party that has constituted the guarantees.

Such guarantees may be executed to satisfy the above rights.

If a system manager has lodged a guarantee in favour of another system manager in relation to an interoperable system, its rights in respect of guarantees by the system manager shall not be affected by the insolvency proceedings initiated against the system operator which has received them, enjoying an absolute right of separation. '

Article 2. Amendment of the recast text of the Securities Market Law, approved by the Royal Legislative Decree 4/2015 of 23 October.

A letter (p) is added to Article 234.2, with the following wording:

" (p) Suspending the exercise of the voting rights associated with the acquired shares until the fulfilment of the reporting obligations set out in Article 125 is recorded at the time of the opening or in the course of a sanctioning file. '

TITLE II

Transposition of the European Union Directive on the exercise of actions for damages for infringements of competition law

Article 3. Amendment of Law 15/2007 of 3 July on the protection of competition in the field of the exercise of damages for infringements of competition law.

One. Article 64 (c) of Article 64 of Law 15/2007 of 3 July of the Defence of Competition is amended as follows:

" c) Performing actions to repair the damage caused.

The effective remedy of the damage prior to the termination of the resolution shall be deemed to be a qualified attenuating. "

Two. A new Title VI is introduced with the following statement and content in Law 15/2007 of 3 July, Defense of Competition:

" TITLE VI

From compensation for damages caused by restrictive practices of competition

Article 71. Liability for infringements of competition law.

1. Violators of competition law will be liable for damages caused.

2. For the purposes of this Title:

(a) Any infringement of Articles 101 or 102 of the Treaty on the Functioning of the European Union or of Articles 1 or 2 of this Law shall be regarded as an infringement of competition law.

b) A company's performance is also attributable to the companies or persons controlling it, except where their economic performance is not determined by any of them.

Article 72. Right to full compensation.

1. Any natural or legal person who has suffered damage caused by an infringement of competition law shall be entitled to claim the infringer and obtain his full redress in the ordinary civil jurisdiction.

2. The full compensation shall be for the person who has suffered damage to the situation in which the infringement of competition law would have been not committed. Such compensation will therefore include the right to compensation for the emerging damage and loss of profit, plus the payment of interest.

3. Full compensation shall not result in overcompensation by means of punitive, multiple or other compensation.

Article 73. Joint and joint responsibility.

1. Companies and associations, associations or groups of undertakings which have jointly infringed the law of competition will be jointly and severally liable for the full compensation of the damages caused by the violation.

2. By way of derogation from the foregoing paragraph, and without prejudice to the right to full compensation, where the infringer is a small or medium-sized undertaking in accordance with the definition given in Commission Recommendation 2003 /361/EC of 6 May 2003, on the definition of micro, small and medium-sized enterprises, will only be responsible to its own direct and indirect buyers in the event that:

(a) its market share in the respective market is less than five percent at all times during the infringement, and

(b) the application of the solidarity liability regime provided for in paragraph 1 shall irredeemably undermine its economic viability and cause a loss of the entire value of its assets.

3. The derogation provided for in paragraph 2 shall not apply where:

a) The company would have directed the infringement or coerced other companies to participate in the infringement, or

(b) the company would have previously been found guilty of an infringement of competition law.

4. By way of derogation from paragraph 1, the persons benefiting from the exemption from the payment of a fine in respect of a leniency programme shall be jointly liable:

a) To your direct or indirect buyers or suppliers, and

(b) to other parties affected only where the full compensation of the other undertakings involved in the same infringement of competition law cannot be obtained.

5. The offender who has paid compensation may repeat against the other offenders for an amount to be determined on the basis of his or her liability for the damage caused.

The amount of the offender's contribution to the exemption from the payment of a fine in the context of a leniency programme shall not exceed the amount of the injury caused to its own buyers or suppliers. direct or indirect. Where the injury is caused to a person or undertaking other than the direct or indirect buyers or suppliers of the offenders, the amount of any contribution from the beneficiary referred to above to other offenders shall be determined in (a) a function of its liability for such injury.

Article 74. Time limit for the exercise of damage actions.

1. Action to require liability for damages suffered as a result of infringements of competition law shall be prescribed at the age of five.

2. The calculation of the time limit shall begin at the time when the infringement of the law of competition has ceased and the complainant is aware or has reasonably been aware of the following circumstances:

(a) The conduct and the fact that it constitutes an infringement of the law of competition;

(b) the injury caused by the said infringement; and

c) the identity of the offender.

3. The time limit shall be interrupted if a competition authority initiates an investigation or a sanctioning procedure in relation to an infringement of competition law relating to the action of damages. The interruption shall end one year after the decision taken by the competition authority is final or the procedure of any other form is terminated.

4. The time limit shall also be interrupted when any procedure for the out-of-court settlement of disputes concerning the claim of damages caused is initiated. The interruption, however, will only apply in relation to parties that are immersed or represented in the out-of-court settlement of the dispute.

Article 75. The effect of the decisions of the competition authorities or the competent courts.

1. The finding of an infringement of the law of competition made in a firm decision of an authority of the Spanish competition or of a Spanish court is to be considered irrefutable for the purposes of an action for damages exercised before a Spanish court.

2. In those cases where, due to the exercise of the actions of damages for infringement of the competition rules, damages are claimed, the existence of an infringement of the law of the Member State shall be presumed, unless proof to the contrary. jurisdiction where it has been declared in a final decision of an authority of the jurisdiction or court of any other Member State, and without prejudice to the fact that it may rely on and prove new facts from which it was not aware originating procedure.

3. This Article shall be without prejudice to the rights and obligations of the courts under Article 267 of the Treaty on the Functioning of the European Union.

Article 76. Quantification of damages.

1. The burden of proof of the damage suffered by the infringement of competition law shall be the responsibility of the applicant.

2. If it was established that the complainant suffered damages but would be practically impossible or excessively difficult to quantify precisely on the basis of the evidence available, the courts would be entitled to estimate the amount of the claim of damages.

3. It shall be presumed that the offences described as a cartel cause damages, unless otherwise proved.

4. In proceedings relating to claims for damages for infringements of competition law, the authorities of the Spanish competition may report on the criteria for the quantification of the compensation which the offenders must satisfy those who have been harmed as a result of them, when required by the competent court.

Article 77. Effects of extrajudicial solutions on the right to compensation for damages.

1. The right to compensation for damages of the injured person who would have been part of an out-of-court settlement will be reduced in the proportional proportion that the offender with whom the agreement had reached the agreement has to the detriment that the infringement of the law of competition caused it.

2. Offenders with whom an out-of-court settlement would not have been reached may not require the offender to have been party to the agreement for a contribution for the remaining compensation.

3. By way of derogation from the above paragraph, where co-offenders who have not reached an out-of-court agreement cannot pay the remaining compensation, the injured person may claim that the compensation to the person with whom he concluded the agreement, unless otherwise agreed.

4. In determining the amount of the contribution that a co-offender may make to any other co-offender in accordance with its liability for the damage caused by the infringement of competition law, the courts shall have due regard in the light of the damages paid in the context of a previous out-of-court settlement involving the respective co-offender.

Article 78. Overruns and right to full compensation.

1. The right to compensation as set out in this Title shall relate only to the cost effectively incurred by the injured party, which has not been passed on and has caused damage to it.

In no case will the compensation of the emergent damage suffered at any level of the chain be able to exceed the damage of the cost to that level.

The right to full compensation will also entail the right of the injured party to claim and obtain compensation for loss of profit as a result of a full or partial impact of the cost overruns.

2. The courts shall have the power to calculate in accordance with the right the part of the cost.

3. The defendant may invoke in his defence the fact that the claimant has passed on all or part of the cost resulting from the infringement of the Competition Law.

The burden of proof that the cost of the cost is passed on to the defendant, which may, to a reasonable extent, require the display of evidence held by the claimant or third parties.

Article 79. Proof of cost overruns and their impact.

1. Where, in the course of an action for damages, the existence of the claim or the determination of the amount of the compensation depends on whether an additional cost was passed on to the claimant or to what extent the action was taken, taking into account the If the price increases are passed on to subsequent points in the supply chain, the burden of proof of the existence and amount of such an impact shall be on the applicant, which may, in a reasonable measure, require the display of evidence held by the defendant or third parties.

2. It shall be presumed that the indirect buyer has credited the cost of the cost when proving that:

(a) The defendant has committed an infringement of competition law;

(b) the infringement of competition law resulted in an additional cost to the direct buyer of the defendant; and

(c) the indirect purchaser acquired the goods or services which were the subject of the infringement of competition law, or acquired goods or services derived from those goods or services.

The presumption will have no effect if the defendant proved that the cost overruns were not, in whole or in part, passed on to the indirect buyer.

Article 80. Damages actions carried out by plaintiffs located at different levels of the supply chain.

1. In order to prevent the actions of damages exercised by the plaintiffs from different levels of supply chain to a multiple liability or to the absence of liability of the offender, the courts that know of a claim for damages arising from an infringement of competition law, when assessing whether the rules of the burden of proof on the impact of cost overruns laid down in the preceding articles are met, may, (i) through the means available in the framework of European Union law or national law, to take in duly consideration of the following elements:

(a) Actions for damages that are related to the same infringement of competition law, but have been filed by plaintiffs located at other levels of the supply chain;

(b) decisions arising from actions for damages referred to in the preceding subparagraph;

(c) the relevant public domain information derived from the public application of competition law.

2. This Article shall be without prejudice to the rights and obligations of the national courts in accordance with Article 30 of Regulation (EU) No 1215/2012.

Article 81. Suspensive effect of the out-of-court settlement of disputes.

Courts which are aware of an action for damages for infringements of competition law may suspend the proceedings for a maximum of two years in case the parties to the proceedings are attempting a of out-of-court settlement of the dispute relating to the said claim. "

Three. Paragraph 2 is amended and a new paragraph 3 is inserted in the fourth additional provision of Law 15/2007 of 3 July of the Defence of Competition, with the following wording:

" 2. For the purposes of this law, a cartel shall mean any agreement or concerted practice between two or more competitors whose objective is to coordinate their competitive behaviour on the market or to influence the parameters of the competition. by practices such as, inter alia, the fixing or coordination of purchase or sale prices or other commercial conditions, including in relation to intellectual and industrial property rights; the allocation of production quotas or for sale; the distribution of markets and customers, including the collusions in invitations to tender, restrictions on imports or exports or measures against other competing competitors.

3. For the purposes of Title VI of this Law,

following definitions shall apply:

1) "action for damages" means any action under national law, by which a party allegedly harmed, or a person representing one or more parties allegedly harmed when the law of the Union or provide for such a right, or a natural or legal person who has subrogated himself to the rights of the allegedly injured party, including the person who acquired the action, who is present before a national court or tribunal tendent on damages;

2) "leniency programme" shall mean any programme relating to the application of Article 101 of the Treaty on the Functioning of the European Union or a similar provision of national legislation according to which a participant in a cartel secret, regardless of the other companies involved, cooperates with the investigation of the competition authority, voluntarily facilitating statements of what the same knows about the cartel and its role in it, in exchange of which receives, by means of a decision or an exemption from the procedure, the exemption from payment of any fine for their participation in the cartel or a reduction thereof;

3) "declaration under a leniency programme" means any statement, verbal or written, voluntarily made by a company or a natural person, or on its behalf, to a competition authority, or to the documentation to the in respect of which the knowledge that the undertaking or natural person has on a cartel and its role in the cartel is described, and which has been specifically drawn up for submission to the authority in order to obtain the exemption or a reduction the payment of the fines in the context of a leniency programme, without this definition including the pre-existing information;

4) "pre-existing information" means evidence that exists independently of the procedure of a competition authority, whether that information is in the file of a competition authority or not;

5) "transaction request" means any declaration made voluntarily by a company, or on its behalf, to an authority of the jurisdiction in which it is recognised or renounces to discuss its participation and responsibility in a infringement of competition law, and which has been specifically developed so that the competition authority can apply a simplified or accelerated procedure;

6) "cost overruns": the difference between the price actually paid and the price that would have prevailed if a breach of competition law had not been committed;

7) "direct buyer" means a natural or legal person who has acquired directly from an infringer products or services that were the subject of a competition law infringement;

8) "indirect purchaser" means a natural or legal person who has acquired not directly from the infringer but from a direct or subsequent purchaser, products or services which were the subject of an infringement of the law of the competence, or products or services containing or derived from them. '

Article 4. Amendment of Law 1/2000 of 7 January of Civil Procedure.

It is introduced in Law 1/2000, of 7 January, of Civil Procedure, a new Section 1. bis within Chapter V ("Of the test: general provisions") of Title I ("From the provisions common to the declarative processes") of Book II ("From declarative processes"), with the following heading and content:

" Section 1. Access to evidence sources in procedures for claims of damages for infringement of competition law

Article 28a (a) Exhibit of evidence in proceedings for the exercise of actions for damages arising from infringements of competition law.

1. Upon request of a plaintiff who has submitted a reasoned statement of reasons containing those facts and evidence to which he reasonably has access, sufficient to justify the viability of the action for damages arising from infringements of competition law, the court may order the defendant or a third party to display the relevant evidence in his possession, subject to the conditions laid down in this Section. The court may also order the plaintiff or a third party to display the relevant evidence, at the request of the defendant.

This request may refer to, among others, the following data:

a) The identity and addresses of the alleged offenders.

b) The conduct and practices that would have constituted the alleged infringement.

c) The identification and volume of the affected products and services.

d) The identity and addresses of the direct and indirect buyers of the affected products and services.

e) The prices applied successively to the affected products and services, from the first transmission to the provision of the consumers or end users.

f) The identity of the affected group.

This paragraph is without prejudice to the rights and obligations of the Spanish courts deriving from Council Regulation (EC) No 1206/2001 of 28 May 2001 on cooperation between the organs of the European Community the courts of the Member States in the field of obtaining evidence in civil or commercial matters.

2. The court may order the display of specific pieces of evidence or relevant categories of evidence, as limited and limited as possible on the basis of facts reasonably available in reasoned reasoning.

3. The court will limit the display of the evidence to whatever is provided. When determining whether the display requested by a party is proportionate, the court shall take into consideration the legitimate interests of all parties and all interested third parties. In particular, it shall take into account:

(a) the extent to which the claim or defence is supported by facts and evidence available to justify the application for evidence display;

b) the scope and cost of the display of the tests, especially for any third party affected, also to avoid the indiscriminate searches for information that is unlikely to be relevant to the parties in question. the procedure;

(c) the fact that the evidence whose display is requested includes confidential information, especially in relation to third parties, and the existing provisions to protect such confidential information.

Article 283 bis b) Rules on confidentiality.

1. The court may order the display of evidence containing confidential information when it considers it relevant in cases of damages. The court, when it orders to display that information and considers it appropriate, shall take the necessary steps to protect confidentiality, as provided for in this article.

2. The interest of undertakings in preventing actions for damages following an infringement of competition law shall not constitute an interest that warrants protection.

3. When ordering the display of the evidence, the court will give full effect to the rules of confidentiality of the communications between the lawyer and client that are applicable, as well as to the rules on the duty to keep secret.

4. The court shall take into account whether the source of evidence to which it is intended to be accessed includes confidential information, in particular in relation to third parties, and the existing provisions to protect such confidential information.

5. Where deemed necessary, in the light of the circumstances of the particular case, the court may order the applicant's access to evidence sources containing confidential information, taking into account effective measures to protect it.

For these purposes, the court may adopt, inter alia, the following measures:

1. Disassociate sensitive passages in documents or other media.

2. Perform hearings behind closed doors or restrict access to them.

3. Limit the people allowed to examine the tests.

4. Encharge experts to draw up summaries of the information in a non-confidential aggregated form or in any other non-confidential form.

5. Compose a non-confidential version of a judicial resolution in which passages containing confidential data have been deleted.

6. Limiting access to certain test sources to the legal representatives and advocates of the parties and to experts subject to confidentiality.

Article 283 bis (c) Expenditure and caution.

1. The costs incurred by the practice of the measures for access to the test sources shall be borne by the applicant. The applicant shall also be liable for any damages that may be caused as a result of improper use of those damages.

2. The person who is interested in a measure of access to sources of evidence may ask the court to provide sufficient caution to the applicant to respond to the costs, as well as the damages which may be caused to him. The court will either agree to this request and, where appropriate, determine the amount of the course. The security may be granted in any of the forms provided for in the second subparagraph of Article 529 (3) of this Law.

3. A course may not be required which, because of its inadequacy, prevents the exercise of the powers provided for in this section.

Article 283 bis (d) Competition.

1. It shall be a court competent to hear applications for access to test sources which are aware of the case at first instance or, if the process has not been initiated, that which is competent to hear the case principal.

2. No declinatory is permitted in the measures of access to test sources, but the court to which it is requested shall review its jurisdiction of its own motion and if it is understood that it is not responsible for knowing the request, it shall refrain from knowing the applicant the court to which he must attend. If this is inhibited in its jurisdiction, the negative conflict shall be decided by the common higher immediate court, as provided for in Article 60 of this Law.

Article 283 bis e) Time for request for access measures to test sources.

1. Measures for access to test sources may be requested prior to the initiation of the process, in the application, or during the process ' pendency.

2. Where the measures have been agreed before the opening of the process, the applicant shall submit a claim within 20 days of the completion of his/her practice. In case you do not:

(a) The court shall, of its own motion, order the applicant to pay the costs and declare that he is responsible for the damage which he has caused to the subject in respect of which the measures were taken, which may be made effective compliance with the provisions of Articles 712 et seq. of this Act;

(b) the court may, at the request of the injured party, agree on the measures necessary for the revocation of the acts of compliance which have been carried out, including, in particular, the return of all types of documents, acts, testimonies and objects; likewise, also at the instance of the injured party, may declare that the data and information collected by the applicant cannot be used by him in any other process, when he or she is abused for his part. These requests shall be substantiated by the channels of the procedure provided for in the following

.

Article 283 bis f) Procedure.

1. Upon receipt of the request, the person shall be transferred to the person to whom the measure is sought and, where appropriate, also to the person in respect of whom the claim or defence is exercised or intended to be exercised, and all parties shall be summoned to an oral hearing, which shall be held within the next 10 days without the need to follow the order of cases pending where the effectiveness of the measure requested so requires.

2. The request for access measures to test sources may also include the application for test assurance measures, if they proceed in accordance with Articles 297 and 298 of this Act. In this case, the procedure provided for in this Article shall be followed.

3. At the hearing, the subjects concerned may set out what is appropriate to their right, using the number of tests available, which will be accepted and practised if they are useful and relevant.

4. After the hearing, the court, within five days, will decide by order. Against this decision, the right to a replacement, with suspensory effects, and if the injured party is dismissed, may, where appropriate, assert its rights in the second instance, but if it is a request made on a prior basis to the The application is lodged directly with the appeal. The appellant may request the suspension of the effectiveness of the contested decision. The court of appeal shall take a decision on the suspension sought by means of a reasoned provision which must be issued after the receipt of the orders, the contested decision being suspended.

5. The costs shall be imposed in accordance with the general criteria laid down in this law.

Article 283 bis g) Execution of the measure of access to test sources.

1. If it is agreed by the court, the provision of caution shall always be prior to any act of compliance with the agreed measure.

2. The court shall use the means necessary for the implementation of the agreed measure and shall have as appropriate the place and mode in which it is to be complied with. In particular, where the agreed measure consists in the examination of documents and certificates, the applicant may be advised by an expert on the subject, who shall always act at his expense.

3. If necessary, the entry and registration of closed and direct places, and the occupation of documents and objects in which they are located, may be agreed by car.

4. At the request of either party the court will dictate providence by terminating the practice of the measure.

Article 283 bis (h) Consequences of obstruction to the practice of access measures to test sources.

1. If the addressee of the measure destroys or hides the evidence, or in any other way makes it impossible for them to have effective access to them, without prejudice to the provisions of paragraph 3 of the foregoing Article and of the criminal liability in which they are Where appropriate, the applicant may, where appropriate, be subject to disobedience to the judicial authority, the applicant may ask the court to impose any or some of the following measures:

a) That you declare as supported facts to which the test sources allegedly referred. For these purposes, the applicant shall set out precisely the facts to which, in his opinion, this statement should be extended.

b) That has the defendant or future defendant tacitly raided the claims made or are to be formulated. For these purposes, the applicant shall set out precisely what the claims are in relation to which a tactical raid is to be declared.

c) That it completely or partially dismisses the exceptions or counterclaims that the subject affected by the measure could exercise in the main proceedings. For these purposes, the applicant shall establish with precision the exceptions or counterclaims to which the dismissal should be extended.

(d) to impose a periodic penalty payment on the recipient of the measures, ranging from EUR 600 to 60 000 per day of delay in the performance of the measure.

2. Any of the above measures may be added to the request that the recipient of the measure be convicted on the costs of the incident of access to the test sources and on the coasts of the main proceedings, whichever is the result of this.

3. The court will transfer this petition to the other parties for a period of ten days to make written submissions, after which it will resolve by order, which will be appealed on appeal.

Article 283 bis (i) Exhibit of evidence contained in a file of a competition authority.

1. The display of the evidence contained in a file of a competition authority shall be governed by the provisions of this Article, and, in so far as they are applicable, by the general provisions of this section.

2. The provisions of this Article shall be without prejudice to the rules and practices in the field of public access to documents in accordance with Regulation (EC) No 1049/2001 of the European Parliament and of the Council of 30 May 2001 on access to of the public to the documents of the European Parliament, the Council and the Commission.

3. The provisions of this Article are also without prejudice to the rules and practices of the law of the Union or of Spanish law on the protection of the internal documents of the competition authorities and the correspondence between them. competition authorities.

4. When assessing the proportionality of an information display order, the court shall, in addition to the requirements of Article 28a (a), examine:

(a) if the application has been specifically formulated in accordance with the nature, object or content of the documents submitted to a competition authority or retained in the files of that authority, instead of by a non-specific application relating to documents provided to a competition authority;

b) if the party applying for the exhibition does so in connection with an action for damages to a national court, and

(c) in conjunction with paragraphs 5 and 10 of this Article, or at the request of a competition authority pursuant to paragraph 11 of this Article, the need to preserve the effectiveness of the public application of the law of the competence.

5. The court may order the display of the following categories of evidence only after a competition authority has terminated its proceedings by adopting a resolution or otherwise:

a) Information that was prepared by a natural or legal person specifically for a procedure of a competition authority;

(b) the information that the competition authorities have prepared and which has been sent to the parties in the course of their proceedings, and

c) the transaction requests that have been withdrawn.

6. At no time may the court order a party or a third party to display any of the following categories of evidence:

(a) statements in the framework of a leniency program, and

b) the transaction requests.

7. A claimant may submit a reasoned request for a court to access the evidence referred to in points (a) or (b) of paragraph 6 with the sole purpose of ensuring that its contents conform to the definitions of the declaration in the framework. of a program of leniency and application for transaction of the third paragraph of the fourth provision of the fourth provision of Law 15/2007, of July 3, of Defense of the Competition. In such an assessment, the courts may request assistance only from competent competition authorities. The authors of the evidence in question shall also be offered the opportunity to be heard. The national court shall in no case allow access by other parties or third parties to such evidence.

8. If only a few parts of the test requested are covered by paragraph 6, the remaining parts shall be displayed, depending on the category in which they are included, in accordance with the relevant provisions of this Article.

9. In the case of damages, the evidence showing in the file of a competition authority may be ordered at all times and shall not be covered by any of the categories listed in this Article.

10. The court shall not require the authorities of the competition to display evidence contained in the files of such evidence, unless any party or third party is able, to a reasonable extent, to provide such evidence.

11. To the extent that a competition authority wishes to express its views on the proportionality of the requirements for display, it may, on its own initiative, submit observations to the court, which is called upon to decide on the eligibility of such display.

Article 283 bis (j) Limits imposed on the use of evidence obtained exclusively through access to the file of a competition authority.

1. Evidence which falls within the categories defined in paragraph 6 of the previous Article, which are obtained by a natural or legal person only through access to the file of a competition authority, shall not be admissible. in actions for damages arising from infringements of competition law.

2. Until the authority of the competition has terminated the procedure with the adoption of a decision or otherwise, the evidence which falls within the categories defined in paragraph 5 of the previous Article, which is obtained by a natural or legal person exclusively through access to the file of that competition authority, shall not be considered admissible in actions for damages arising from infringements of competition law or shall be protected from another mode according to the applicable rules.

3. Evidence which is obtained by a natural or legal person solely by means of access to the file of a competition authority and which is not covered by paragraphs 1 or 2 of this Article may be used only in a action for damages arising from infringements of competition law by that person or by the natural or legal person who is the successor of his rights, including the person who has acquired his or her claim.

Article 283 bis k) Consequences of non-compliance with confidentiality obligations and use of test sources.

1. Without prejudice to the criminal liability in which the offence of disobedience to the judicial authority may be committed, in the event that any duty of confidentiality in the use of evidence sources is breached or the limits are not fulfilled in the use of these test sources, the injured party may request the court to impose any or some of the following measures:

(a) The total or partial dismissal of the action or exceptions exercised or opposed in the main proceedings, if this is pending at the time the application is made. For these purposes, the injured party shall set out precisely the actions or exceptions to be rejected.

b) To declare the offender civilly liable for the damages caused and to condemn him to his payment. The amount of damage may be determined in accordance with the provisions of Articles 712 et seq. of this Act.

(c) The offender should be convicted on the costs of the incident of access to the test sources and on the coasts of the main process, whichever is the result of the incident.

2. If the court finds that the non-compliance is not serious, it may, instead of having access to what is requested by the injured party, impose a fine of between 6,000 and 1,000,000 euros on the infringer. For these purposes, the party and its legal representatives and defenders may be considered as infractions, and each of them may be subject to separate fines.

3. The court shall transfer the application referred to in paragraph 1 to the other parties for a period of 10 days to make written submissions, after which it shall decide by order, which shall be subject to appeal. '

TITLE III

Transposition of directives from the European Union on health matters

Article 5. Amendment of Royal Decree-Law 9/2014 of 4 July laying down quality and safety standards for the donation, procurement, evaluation, processing, preservation, storage and distribution of cells and tissues The standards of coordination and functioning for human use are approved and approved.

Royal Decree-Law 9/2014 of 4 July establishing quality and safety standards for the donation, procurement, evaluation, processing, preservation, storage and distribution of cells and human tissues and the rules for coordination and operation for use in humans are approved, as amended in the following terms:

One. New letters are added from and to the ap) in Article 2 (1), with the following wording:

"and) European Single Code or" SEC ": unique identifier that applies to the tissues and cells distributed in the European Union consisting of a sequence of identification of the donation and one the product identification sequence as detailed in Annex VII.

z) Sequence of identification of donation: first part of the single European code, consisting of the European Union's tissue establishment code and the unique donation number.

aa) EU tissue establishment code: unique identifier for accredited, designated, approved or approved tissue establishments in the European Union consisting of an ISO country code and the number of the tissue establishment as set out in the EU Fabric Establishment Compendium, as detailed in Annex VII.

ab) Single donation number: unique number assigned to a particular donation of tissues and cells in accordance with the system in force in Spain to assign such numbers, as detailed in Annex VII.

ac) Product identification sequence: second part of the European single code, consisting of the product code, the sublot number, and the expiration date.

ad) Product code: identifier for the specific type of tissue or cell in question that consists of the identifier of the product coding system indicating the coding system used by the establishment of tissues ("E" for EUTC, "A" for ISBT128 and "B" for Eurocode) and the product number of the tissues and cells provided for in the respective coding system for the product type as detailed in Annex VII.

(ae) Sublot number: distinguishing number and uniquely identifying tissues and cells having the same unique donation number and product code and originating from the same tissue establishment, as detailed in Annex VII.

af) Date of expiry: the date to which the tissues and cells may be applied, as detailed in Annex VII.

ag) EU Codification Platform: computer platform, hosted by the Commission, which contains the EU's Fabric Establishment Compendium and the Cellular Products Compendium.

ah) Compendium of EU Fabric Facilities: Registration of all tissue establishments which have been approved, approved, designated or accredited by the competent authority or authorities of the Member States and containing information on such tissue establishments, as set out in Annex IX.

ai) Compendium of EU tissue and cell products: recording of all types of tissues and cells circulating in the European Union and the respective product codes according to the three coding systems allowed (EUTC, ISBT128 and Eurocode).

aj) EUTC: a system for coding products for tissues and cells developed by the European Union, consisting of a record of all types of tissues and cells circulating in the European Union and their product codes corresponding.

ak) Puesta in circulation: distribution for application in humans or transfer to another operator, for example, for subsequent processing, with or without return.

al) In the same center: it means that all phases of the process, from obtaining to the application in human beings, are carried out under the same person responsible, the same system of quality management and the same system for traceability, in a health care facility comprising at least one authorised establishment and an organisation responsible for the application in human beings at the same place.

am) Batch grouping: physical contact or mixing, in the same container, of tissues or cells from more than one donor, or from two or more donors.

an) Emergency: any unforeseen situation where there is no other practical alternative other than the urgent importation into the European Union of cells and tissues from a third country for immediate application to a known receptor or known receptors whose health would be seriously threatened if such importation was not performed.

an) Establishment of importing tissues: a tissue bank, a hospital unit or any other body established in the European Union, which is party to a contractual agreement with a third country supplier for the import into the European Union of cells and tissues from a third country intended for human use.

(ao) Exceptional import: the import of any specific type of cell or tissue that is intended for the personal use of a recipient or recipient known to the importing tissue establishment and by the supplier of the third country prior to import. Typically, such an import of any specific type of cell or tissue will not occur more than once for a given recipient. Imports from the same supplier of a third country which take place on a regular or repeated basis shall not be considered as 'exceptional imports'.

(ap) Supplier of a third country: a tissue establishment or other body established in a third country, which is responsible for exporting cells and tissues to the European Union through its supply to a importing tissues. A third-country supplier may also carry out one or more of the activities, carried out outside the European Union, of donation, procurement, evaluation, processing, preservation, storage and distribution of cells and tissues. imported into the European Union. "

Two. A new paragraph 4 is added to Article 23, and the following paragraphs are renumbered accordingly, and paragraph 4 is amended, renumbered as 5, and the first subparagraph of paragraph 6, which shall be renumbered as 7, which shall have the following wording:

" 4. All imports of tissues and cells shall be carried out through the importing tissue establishments covered by Article 23a, except in the following cases:

(a) Import, with prior and direct authorisation from the competent authority, of specific tissues and cells which can be distributed directly to the recipient immediately, provided that the supplier has the authorization for this activity.

b) Import of tissues and cells authorised directly by the competent authority in emergency cases. "

" 5. Applications for the import and export of cells and tissues shall be addressed to the National Transplant Organisation, as appropriate, by the establishment of tissues, the establishment of importing tissues, the centre or the unit involved, with the prior knowledge of the transplant coordination unit of the appropriate autonomous community. The National Transplant Organisation shall forward the applications to the Deputy Director-General for External Health of the Ministry of Health, Social Services and Equality, together with its report, for processing. "

" 7. In order to ensure compliance with the provisions of the previous paragraph, the establishment of tissues or the establishment of importing tissues, as appropriate, shall issue a certificate accompanying the application for import and export.

In the case of tissue and cell imports, the certificate shall contain the following information: "

Three. A new Article 23a is added, which is worded as follows:

" Article 23a. Authorisation of the activities of the importing tissue establishments.

1. The importing tissue establishments, prior to the application for authorisation for the exercise of their import activities, should take the necessary measures to ensure that the imports of tissues and cells comply with the requirements of this Regulation. the quality and safety standards equivalent to those set out in this Royal Decree-law and that such tissues and cells can be traced from the donor to the recipient and vice versa.

In addition, they shall conclude, as provided for in Article 23b, written agreements with third-country suppliers provided that certain activities of donation, procurement, evaluation, processing, preservation, storage or export to the European Union of the tissues and cells to be imported into the Union shall be carried out outside the Union.

2. After compliance with the above paragraph, and without prejudice to the specific rules of each Autonomous Community, the importing tissue establishments shall submit an application for authorisation to the competent authority with the information referred to in Annex X, together with the documentation referred to in paragraph 6 of that Annex. This documentation should include a copy of the written agreements with third country suppliers.

They shall also make available and, when requested by the competent authority, the documentation referred to in Annex XII.

However, in the case of exceptional imports, the documentation referred to in paragraph 6 of Annex X and Annex XII shall not be required, provided that it is ensured by the necessary documentation, traceability from the donor to the recipient and vice versa, and the non-use of the cells and tissues in a person other than the intended recipients.

In the case of establishments of textile importers which have previously been authorised as tissue establishments or as importing tissue establishments, it shall not be necessary to present the information or documentation already. provided in the course of the respective procedure.

3. The competent authority shall verify that the importing tissue establishments comply with the requirements for the exercise of their import activities and shall decide on the authorisations indicating, where appropriate, the applicable conditions, such as: as restrictions on the import of certain types of cells and tissues or as regards third country suppliers used.

The competent authority shall issue the certificate provided for in Annex XI to each importing tissue establishment that is authorised.

4. In the event that substantial changes or modifications are intended to be made to the import activities, the importing tissue establishments shall obtain the prior written authorisation from the competent authority.

In particular, any changes in the type of imported cells and tissues and in activities carried out in third countries that may influence the quality and safety of cells and tissues are considered to be substantial. the imported tissues or third country suppliers used.

Where an importing tissue establishment makes an exceptional import of cells or tissues from a third country supplier which is not included in its existing authorisation, such import shall not be considered as a substantial modification if the establishment is authorised to import the same type of cell or tissue from another or other third country supplier.

5. Authorisations may be revoked or suspended, in whole or in part, if after inspections or other control measures it is found that the importing tissue establishments have ceased to comply with the requirements for their authorisation.

6. Importing tissue establishments may at any time communicate to the competent authority their decision to terminate, in whole or in part, their import activities. '

Four. A new Article 23b is added, which is worded as follows:

" Article 23b. Written agreements with third country suppliers.

1. Written agreements concluded by importing tissue establishments with third country suppliers shall specify the quality and safety requirements to be met in order to ensure the equivalence of quality standards. and the safety of the tissues and cells to be imported with those laid down in this Royal Decree-Law, including at least the aspects listed in Annex XIII.

2. These agreements shall expressly provide for the right of the competent authority to inspect the activities, including installations, of any third-country supplier during the period of validity of the written agreement and during a two-year period from its termination.

3. Such agreements shall not be necessary in the case of exceptional imports provided that it is ensured by the necessary documentation, traceability from the donor to the recipient and vice versa, and the non-use of the cells and the tissues in a person other than the intended recipients.

4. The importing tissue establishments shall notify the competent authority without delay:

(a) Any revocation or suspension, in whole or in part, of the export authorisation of cells and tissues of the supplier of a third country.

(b) Any other decision which, in the event of non-compliance, takes the competent authority or authorities of the country in which the supplier of a third country is established and which may influence the quality and safety of the imported cells and tissues. "

Five. A new paragraph 4 is added to Article 25, which is worded as follows:

" 4. Importing tissue establishments shall keep a record of their activities, including the types and quantities of imported tissues and cells, as well as their origin and destination. Such registration shall include the same information in relation to exceptional imports. '

Six. Article 28 (3) is amended and read as follows:

" 3. Cell and tissue application centres shall inform the tissue establishment, the establishment of the importing tissue or, where appropriate, the procurement centre which has supplied them with the cells and tissues, on the final destination of the tissue. human application of these cells or tissues, and in the event that the application does not occur, the cause that did not make it possible. "

Seven. Article 30 is amended as follows:

" 1. The National Transplant Organisation, without prejudice to the registration powers of the autonomic authorities, shall develop and maintain a register of tissue establishments, importing tissue establishments, and units or centres for obtaining and applying authorised human tissues and cells, where the specific activities for which they are authorised shall be specified for each of them. This register will be accessible to the public.

2. The transplant coordination units of the autonomous communities shall communicate in real time to the National Transplant Organisation the information relating to tissue establishments, importing tissue establishments and centres or units for obtaining and applying tissues and cells which are authorised in the field of their competence, in order to include it in this register. Such information shall include at least the name and location of the establishment, unit or approved centre, the activities for which they are authorised and the periods of validity of those authorisations.

3. The National Transplant Organisation shall appoint a technical officer for the maintenance and custody of the registry. "

Eight. Article 32 (3) and (4) are amended as follows:

" 3. The National Transplant Organisation shall draw up an annual report containing information on tissue establishments, importing tissue establishments, units or centres for the collection and application of cells and tissues. human, as well as the activities developed. This report, which shall in no case contain personal data relating to donors and recipients, shall be accessible to the public and shall be transmitted to all the centres and units involved and shall include data of general interest to which due dissemination.

4. The Ministry of Health, Social Services and Equality, through the National Transplant Organisation, will collaborate with the European Commission and the other Member States of the European Union in the development of an information exchange network. between the national registers of tissue establishments, importing tissue establishments, and of approved human tissue and cell procurement centres or units. '

Nine. Paragraph 6 is amended and two new paragraphs 7 and 8 are added to Article 33, which shall be worded as follows:

" 6. The National Transplant Organisation, in coordination with the autonomous communities, will ensure that tissues and cells can be traced, in particular through the documentation and use of the single European code, from procurement to the application in human beings or elimination and vice versa. Tissues and cells used for advanced therapy medicinal products shall be able to be traced in accordance with this Royal Decree-Law, at least until they are transferred to the advanced therapy medicinal product manufacturer.

7. The National Transplant Organization, in coordination with the autonomous communities, will ensure that tissue establishments and organizations responsible for human application preserve, safely, data laid down in Annex VI for a minimum of 30 years, in an appropriate and legible storage medium.

8. In the case of tissues and cells that have been recovered from a deceased donor by procurement teams working for two or more tissue establishments, the National Transplant Organization, in coordination with the communities It shall ensure an appropriate traceability system through the provision of the information. "

Ten. Article 34 is worded as follows:

" Article 34. European coding system.

1. The single European code shall apply to all tissues and cells distributed in Spain for application in human beings.

For other situations in which tissues and cells are put into circulation, the sequence of identification of the donation of that code shall be applied, at least, in the accompanying documentation.

2. The above paragraph shall not apply to:

a) Donation of reproductive cells between members of a partner.

(b) The import or export of human tissues and cells with prior and direct authorisation from the competent authority, provided that it is for direct distribution for immediate transplantation to the recipient, and provided that the provider has the authority for that activity.

(c) The import of cells and tissues authorised directly by the competent authority or authorities in case of emergency.

d) tissues and cells that are not reproductive cells for donation between members of a partner, when such tissues and cells remain in the same center.

e) tissues and cells imported into the European Union, when such tissues and cells remain in the same centre from import to the application, provided that the centre includes an establishment of fabrics authorized to carry out import activities.

3. The format and structure of the single European code are set out in Annex VII.

4. The application of the single European code does not exclude the additional application of other codes in accordance with the requirements laid down in our legal order. "

Once. A new Article 34a is added, which will have the following wording:

" Article 34a. Obligations of tissue establishments relating to the application of the single European code.

Tissue establishments, including importing tissue establishments, shall:

a) Assign a single European code to all tissues and cells that require the application of such code before being distributed for application in humans.

b) Assign a sequence identifying the donation after obtaining the tissues and cells, or receiving them from a procurement organization, or by importing them from a third country supplier. The donation identification sequence will include:

1. Your European Union tissue establishment code, as assigned in the EU Fabric Establishment Compendium.

2. A unique donation number assigned by the tissue establishment, unless such number is a unique worldwide number such as those used by the ISBT128 coding system. In the case of reproductive cells, the allocation of the single donation number shall be established by the Ministry of Health, Social Services and Equality, centrally at national level. A new identification number of the donation shall be assigned to the final product where it is permitted, in the case of a pool of tissues and cells. The establishment of tissues in which the batch grouping is performed will ensure the traceability of individual donations.

c) Do not alter the identification sequence of the donation once it has been assigned to tissues and cells put into circulation, unless necessary to correct a coding error; any correction requires a appropriate documentation.

d) Use one of the permitted product coding systems, in this case the corresponding tissue and cell product numbers listed in the EU's Cell and Tissue Product Compendium or, in its defect, the ISBT128, before they are distributed for application in humans.

e) Use an appropriate sublot number and expiration date. In the case of tissues and cells for which the expiry date has not been defined, this will be, at the latest, a pre-distribution of 00000000 for human application.

(f) Apply the single European code on the label of the product concerned in an indelible and permanent manner and mention that code in the relevant accompanying documentation prior to the distribution for application in beings human. The tissue establishment may entrust this task to a third party or third parties, provided that the tissue establishment ensures compliance with this Royal Decree-law, in particular as regards the uniqueness of the code. If the label size prevents the European single code from being applied to it, the code shall be unequivocally linked to the tissues and cells packed with a label of this type in the accompanying documentation.

g) Report to the competent authority when:

1. No need to update or correct information in the EU's Fabric Establishment Compendium.

2. The EU's Cellular and Cell Products Compendium requires an update.

3. The establishment of tissues will detect an important non-compliance with the requirements for the single European code in relation to tissues and cells received from other EU tissue establishments.

h) Take the necessary measures in case of incorrect application of the single European code on the label. "

Twelve. A new Article 34b is added, which will have the following wording:

" Article 34 ter. Actions of the competent authorities concerning the implementation of the single European code.

1. The competent authorities shall carry out the following actions:

(a) Ensure the allocation of a unique number of tissue establishment to all approved tissue establishments in Spain.

If a tissue establishment has different physical locations, but a single system to assign unique donation numbers, it can be considered to be a single tissue establishment.

If a tissue establishment uses two or more systems to assign unique donation numbers, that entity will be assigned different tissue establishment numbers that correspond to the number of allocation used.

b) Track and ensure the effective implementation of the single European code in Spain.

c) Ensure the validation of the data on tissue establishments listed in the EU's Compendium of Tissue Facilities for Spain and update that Compendium without undue delay, in particular in the The following situations:

1. º When a new tissue establishment is authorized.

2. º When information about tissue establishment changes or does not register correctly in the EU Fabric Establishment Compendium.

3. When the details on the authorisation of a tissue establishment listed in Annex IX are changed, inter alia:

1. The authorization of a new type of tissue or cell.

2. The authorization of a new prescribed activity.

3. The details about any conditions or exceptions that are added to an authorization.

4. The suspension, partial or total, of a specific authorization for a particular activity or type of tissue or cell.

5. The revocation, partial or total, of an authorization of a tissue establishment.

6. The situations in which the tissue establishment voluntarily, partially or completely ceases the activity or activities for which it has been authorised.

Without undue delay means within a maximum period of ten working days for any changes that substantially affect the authorisation of the tissue establishment concerned.

Where a tissue establishment is authorised by two or more competent authorities for different types of tissues and cells, or for different activities, each competent authority shall update the information relating to: those activities that you are responsible for.

(d) to alert the competent authorities of another Member State when they detect incorrect information in the EU's Fabric Establishment Compendium in relation to the other Member State or when they detect a situation of significant non-compliance with the provisions relating to the single European code in relation to the other Member State.

e) To alert the Commission and the other competent authorities when, according to their assessment, an update of the EU's Tissue And Tissue Product Compendium is required. "

Thirteen. Article 35 (4) is amended as follows:

" 4. Tissue establishments that process or preserve tissues that may be affected by any serious adverse reaction or effect shall issue a detailed report of possible causes and consequences, as well as of the measures taken and of which they are to be adopted.

For their part, the importing tissue establishments shall inform the competent authority without delay of any serious adverse reaction or serious adverse effects, presumed or actual, communicated to them by the suppliers of third countries and which can influence the quality and safety of the cells and tissues that matter. The information referred to in Annex VIII shall be included in this type of communications. '

Fourteen. A new Article 36a is added, which will have the following wording:

" Article 36a. Inspection and other control measures on importing tissue establishments and suppliers from third countries.

1. The competent authorities shall organise inspections and other control measures in the importing tissue establishments and, where appropriate, in their third country suppliers. In addition, the importing tissue establishments shall carry out appropriate checks to ensure the equivalence of the quality and safety standards of the cells and tissues to be imported with the standards laid down in this Regulation. Royal Decree-law. The interval between two inspections of a given importing tissue establishment may not exceed two years.

2. Such inspections shall be carried out by officials representing the competent authority, who shall:

(a) Be empowered to inspect the importing tissue establishments and, where appropriate, the activities of third country suppliers.

b) Evaluate and verify the procedures and activities carried out in the importing tissue establishments and in the facilities of third country suppliers that are relevant to ensure the equivalence of the quality and safety standards of the cells and tissues to be imported with the standards set out in this Royal Decree-Law.

c) Browse any document or other record that is relevant to such assessment and verification.

3. The Ministry of Health, Social Services and Equality, through the National Transplant Organisation, in coordination with the Autonomous Communities, upon duly justified request of another Member State or of the Commission, shall provide information on the results of the inspections and control measures with regard to the importing tissue establishments and third country suppliers.

4. The Ministry of Health, Social Services and Equality, through the National Transplant Organization, in coordination with the Autonomous Communities, upon duly justified request of another Member State in which they are to be distributed subsequently the imported cells and tissues, shall carry out inspections or other control measures, taking the appropriate measures after consultation with the Member State which submitted that application, in the importing tissue establishments and with regard to the activities of third country suppliers.

5. In cases where an on-the-spot inspection is carried out following the request of another Member State, the Ministry of Health, Social Services and Equality, through the National Transplant Organisation, in coordination with the autonomous communities, shall decide, in agreement with the competent authority of the Member State which submitted such an application, whether the latter should participate in the inspection and in what manner. The final decision on this participation is the responsibility of the Ministry of Health, Social Services and Equality, through the National Transplant Organization, in coordination with the autonomous communities, if the establishment of importing tissues is within its territorial jurisdiction. The reasons for a refusal of such participation shall be explained to the Member State which submitted the application. '

Fifteen. A new point 7 is added and the last paragraph of point (i) (i) of Annex I (i) is amended, with the following wording:

" 7. the European single code applicable to tissues and cells distributed for application in humans or the identification sequence of the donation applicable to the tissues and cells put into circulation but not distributed for application in human beings.

In the event that any of the data referred to in points 4, 5 and 7 cannot be included in the label of the primary container, they shall be provided on a separate sheet to be attached to the primary container. This sheet must be packaged with the primary container so that it is guaranteed to remain together. "

Sixteen. The current points in point (ii) of point (ii) of point (ii) of Annex I are numbered 1 to 9, and a new point 10 is added, with the following wording:

"10) In the case of imported tissues and cells, the country of production and the exporting country (if different from the country of production)."

seventeen. Annex VI is amended, which will have the following wording:

" ANNEX VI

Minimum information required in the traceability system of origin to target cells and human tissues obtained for human application

1. For tissue establishments:

a) Identification of the donor.

b) Identification of the donation, including at least:

1. th Identification of the procurement body (including contact information) or tissue establishment.

2. No. Single donation identification number.

3. Date Get Date.

4. Place of getter.

5. Type of donation (e.g., one or more tissues; autologous or allogeneic; living or deceased donor).

c) Product identification, including at least:

1. Identification of tissue establishment.

2. Type of tissue and cell/product (basic nomenclature).

3. ° Batch Group Number (if any).

4. Number of sublot (if any).

5. The expiration date (if any).

6. The situation of tissue or cells (for example, in quarantine, suitable for use, etc.).

7. The description and origin of the products, applied processing phases, materials and additives that come into contact with tissues and cells and have an effect on their quality and/or their safety.

8. º Identification of the installation that issues the final tag.

d) Single European code (if applicable).

e) Identification of the application in human beings, including at least:

1. Date of Distribution/Removal.

2. Medical or end-user identification/final installation.

2. For the organizations responsible for the application in human beings:

a) Identification of vendor tissue establishment.

b) Identification of the physician or end user/installation.

c) Type of tissues and cells.

d) Identification of the product.

e) Identification of the receiver.

f) Date of application.

g) Single European code (if applicable). "

Eighteen. Annex VII is amended, as follows:

" ANNEX VII

Format and structure of the European single code.

1. FORMAT OF THE EUROPEAN SINGLE CODE

The European single code must be in a legible format and be preceded by the acronym "SEC". Parallel use of other labelling and traceability systems will be possible.

The single European code shall be printed together with the identification sequence of the donation and the sequence of identification of the product, separated by a single space or two successive lines.

2. STRUCTURE OF THE EUROPEAN SINGLE CODE

nineteen. Annex VIII is amended, which will have the following wording:

" ANNEX VIII

1. SERIOUS ADVERSE REACTIONS

2. SERIOUS SIDE EFFECTS

Twenty. Five new annexes are added, numbered IX, X, XI, XII and XIII, which will have the following wording:

" ANNEX IX

Data to be recorded in the EU Fabric Establishment Compendium

1. Tissue establishment information:

a) Designation of tissue establishment.

b) National or international tissue establishment code.

c) The name of the organization in which the tissue establishment is located (if applicable).

d) Address of tissue establishment.

e) Public contact data: a functional email address, telephone, and fax.

2. Data on the authorisation of tissue establishment:

(a) Denomination of the competent authority or authorities.

(b) Denomination of the competent national authority or authorities responsible for the maintenance of the EU Fabric Establishment Compendium.

c) Name of the authorization holder (if applicable).

d) Fabric and cells for which authorization was granted.

e) Activities actually carried out for which the authorization was granted.

f) Status of authorization (authorized, suspended, revoked, partially or totally, voluntary cessation of activity).

g) Details about the conditions and exceptions added to the authorization (if any).

ANNEX X

Minimum requirements for the information and documentation to be submitted by importing tissue establishments when they request authorisation for the purpose of their import activities

When you request authorization to perform import activities, the importing fabric establishment must provide, unless it has already been provided as part of previous authorization requests such as tissue establishment or as an importer tissue establishment, the following updated information and, for Part 6, the documentation indicated.

1. General information on the establishment of importing tissues (TSIs):

a) The name of the TSI (company name).

b) Physical address of the TSI.

c) The postal address of the TSI (if different from the previous one).

(d) Status of the applicant TSI: indicate whether this is the first application for authorisation as a TSI or, where applicable, whether it is an application for renewal. In case the applicant has already been authorised as tissue establishment, it shall provide its compendium code.

e) The name of the requesting unit (if different from the company name).

f) The physical address of the requesting unit.

g) The postal address of the requesting unit (if different from the previous one).

h) Name of the place of receipt of the imports (if not the same as the name of the company and the requesting unit).

i) Physical address of the place of receipt.

j) The postal address of the place of receipt (if different from the previous one).

2. Contact details for the request:

a) The name of the contact person for the request.

b) Phone number.

c) Email address.

d) Name and last name of the person responsible (if not the same as the contact person).

e) Phone number.

f) Email address.

g) URL of the TSI website (if available).

3. Detailed information on the tissues and cells to be imported:

a) List of the types of tissues and cells to be imported, including exceptional imports of specific types of tissues or cells.

b) Name of the product (if applicable, in accordance with the EU generic list) of all types of tissues and cells to be imported.

c) Trade name (if different from the name of the product) of all types of tissues and cells to be imported.

d) Name of the third country provider for each type of tissue and cells to be imported.

4. Location of activities:

(a) List in which the activities of donation, procurement, evaluation, processing, storage or storage carried out prior to importation by the third country supplier are indicated, by type of tissue or cell.

(b) List in which the activities of donation, procurement, evaluation, processing, storage or storage carried out prior to importation by subcontractors of the third-country supplier are indicated, by type of tissue or cell.

c) List of all activities carried out by the TSI after importation, by type of tissue or cell.

(d) Names of third countries in which the activities are carried out prior to the import, by type of tissue or cell.

5. Data from third country suppliers:

a) Name of the supplier/supplier of the third country (company name).

b) Name of the contact person.

c) Physical address.

d) Postal address (if different).

e) Telephone number (including international prefix).

f) Emergency contact number (if different).

g) Email address.

6. Documentation attached to the request:

a) Copy of the written agreement with the third country supplier/s.

(b) Detailed description of the flow of imported tissues and cells, from their procurement to their reception in the establishment of importing tissues.

(c) Copy of the export authorisation certificate of the third-country supplier or, in the event that a specific export authorisation has not been issued, a certificate from the competent authority or authorities of the third country concerned by which the activities of the third country supplier in the tissues and cells sector, including exports, are authorised. This documentation should also include the contact details of the competent authority or authorities of the third country. In third countries where such documentation is not available, other documents such as, for example, reports of audits made to the third-country supplier will be provided.

ANNEX XI

Certificate of authorisation issued by the competent authority or authorities to the importing tissue establishments

ANNEX XII

Minimum requirements for documentation to be submitted by tissue establishments wishing to import tissues and cells from third countries to the competent authority or authorities

Except in the case of exceptional imports as defined in Article 2, which are exempt from these documentation requirements, the establishment of importing tissues shall make available and, unless they have already been provided as part of previous applications for authorisation as an importing tissue establishment, shall provide, upon request by the competent authority or authorities, the most up-to-date version of the following documents concerning the applicant and his third country supplier (s).

1. Documentation relating to the establishment of importing tissues:

(a) Description of the roles of the responsible person and detailed information on their qualifications and training, as set out in Article 17 for the technical staff of tissue establishments.

b) Copy of the primary label, the label of the repackage, the outer container, and the transport container.

c) List of relevant and updated versions of the standard operating procedures (PON) relating to the import activities of the establishment, including the PON for the implementation of the single European code, the reception and storage of cells and tissues in the establishment of importing tissues, management of reactions and adverse effects, management of product recoveries and their traceability of the donor to the recipient.

2. Documentation relating to the supplier or suppliers of the third country:

(a) Detailed description of the criteria used for the identification and assessment of the donor, the information provided to the donor or his/her family, the way in which the donor or his/her consent has been obtained family and confirmation or not of the voluntary and unpaid nature of the donation.

(b) Detailed information on the assessment centre (s) used by third country suppliers and the tests carried out by third countries.

c) Detailed information about the methods used during tissue and cell processing, including details of validation of the critical processing procedure.

d) Detailed description of the critical facilities, equipment and materials and the criteria used for quality control and the monitoring of the environment for each of the activities carried out by the supplier of the third country.

e) Detailed information on tissue and cell delivery conditions by the third country provider (s).

(f) Data for subcontractors used by third-country suppliers, including the name, location and activity performed.

g) Summary of the most recent inspection of the third country supplier by the competent authority or authorities of that third country, including the date and type of inspection, as well as the principal conclusions.

h) Summary of the most recent audit of the third-country supplier by the importing tissue establishment or on its behalf.

i) Any relevant national or international accreditation.

ANNEX XIII

Minimum requirements for the content of written agreements between importing tissue establishments and their suppliers in third countries

Except in the case of exceptional imports as defined in Article 2, which are exempt from compliance with these requirements, the written agreement between the importing tissue establishment and the third country supplier must include at least the following:

1. Detailed information on the specifications of the importing tissue establishment in order to ensure that the quality and safety standards established in this Royal Decree-Law and the roles and responsibilities of each other are met agreed by both parties to ensure that the imported tissues and cells comply with equivalent quality and safety standards.

2. A clause ensuring that the supplier of the third country shall provide the information required in Part 2 of Annex XII to the establishment of importing tissues.

3. A clause ensuring that the supplier of the third country shall inform the establishment of tissues of any suspicion or confirmation of a serious adverse reaction or effect that may influence the quality and safety of the tissues and cells which have been or are to be imported by the importing tissue establishment.

4. A clause ensuring that the supplier of the third country informs the establishment of the importing tissues of any substantial change in its activities, including the revocation or suspension, in whole or in part, by the authority or competent authorities, their authorisation to export tissues and cells or other decisions in the event of non-compliance, which may influence the quality and safety of the tissues and cells which have been or are to be imported by the establishment of importing tissues.

5. A clause conferring on the competent authority or authorities the right to inspect the activities of the third-country supplier, including on-the-spot inspections, if they so wish, in the framework of their inspection of the establishment of importing fabrics. The clause should also ensure that the right to audit a third country supplier is also ensured by the establishment of importing tissues.

6. The agreed conditions to be met for the transport of tissues and cells between the third-country supplier and the establishment of importing tissues.

7. A clause ensuring that the supplier of the third country or its subcontractor shall keep data relating to donor cells and tissues imported in line with the data protection rules of the European Union during a period of 30 years after obtaining and the appropriate arrangements for their conservation shall be adopted in the event that the supplier of the third country ceases its activity.

8. Provisions for the periodic review and, if necessary, for the revision of the written agreement, in order to reflect the possible changes in the requirements of the European Union quality and safety standards established in this Royal Decree-Law.

9. A list of all the standard operating procedures of the third-country supplier relating to the quality and safety of the imported cells and tissues and the commitment to provide them upon request. '

TITLE IV

Transposition of the European Union directive on the posting of workers

Article 6. Amendment of Law 45/1999 of 29 November on the posting of workers in the framework of the provision of transnational services.

Law 45/1999 of 29 November on the posting of workers in the framework of the provision of transnational services is amended in the following terms:

One. A paragraph 3 is added to Article 2 with the following wording:

" 3. For the purposes of mutual recognition and assistance in the cross-border notification and enforcement of administrative penalties resulting from non-compliance with the posting of workers, the following definitions shall apply:

1. "petitioning authority": the competent authority of a Member State making the request for assistance, information, notification or recovery of a penalty or a fine according to the additional provision sixth;

2. "Request receiving authority" shall mean the competent authority of a Member State to which the request for assistance, information, notification or recovery of a penalty or a fine is addressed according to the additional provision sixth. "

Two. Article 5 (1), (2) and (4) are worded as follows:

" 1. For the purpose of ensuring compliance with this law, the employer who moves workers to Spain in the framework of a transnational provision of services must communicate the posting, before the date of its commencement and regardless of its duration, to the competent Spanish labour authority for the territory in which the services are to be provided. The communication shall be made by electronic means, in such a way as to be determined by regulation. To this end, the Ministry of Employment and Social Security shall establish, in agreement with the Autonomous Communities, a central electronic register of such communications. "

" 2. The displacement communication shall contain the following data and information:

a) The identification of the company that displaces the worker.

(b) The tax domicile of that undertaking and its identification number for the purposes of Value Added Tax.

c) The personal and professional data of posted workers.

(d) The identification of the undertaking (s) and, where appropriate, of the centre (s) where the posted workers will provide their services.

e) The expected start date and duration of the offset.

(f) The determination of the provision of services to be developed by the posted workers in Spain with an indication of the assumption corresponding to those provided for in Article 2.1.1

g) The identification and contact details of a natural or legal person present in Spain who is designated by the company as its representative to serve as liaison with the competent Spanish authorities and for the shipment and receiving documents or notifications, if necessary.

h) The identification and contact details of a person who can act in Spain on behalf of the company providing services in the procedures for information and consultation of workers, and negotiation, which affect the posted workers to Spain. "

" 4. Where the undertaking moving the workers to Spain is a temporary work undertaking, the posting of travel, in addition to the provisions of paragraph 2, shall include:

(a) The accreditation that meets the requirements required by the legislation of its State of establishment to make available to another user undertaking, on a temporary basis, workers employed by it.

(b) Without prejudice to paragraph 2.f.), the accuracy of the temporary needs of the user undertaking which are to be met with the contract for making available, with an indication of the alleged conclusion that corresponds to the provisions of Article 6.2 of Law 14/1994 of 1 June 1994 governing temporary employment undertakings. '

Three. Article 6 is worded as follows:

" Article 6. Obligation to appear and to maintain and contribute documentation.

1. Employers falling within the scope of this law must, at the request of the Labour and Social Security Inspectorate, appear in the public office designated for this purpose and provide all the documentation required for them. to justify compliance with this law, including the supporting documentation of the company's valid constitution.

2. Without prejudice to the provisions of the previous paragraph, during the period of posting, employers shall have available, at the working centre or in digital format for immediate consultation, inter alia, the following documents:

(a) The contracts of employment or the documents referred to in Article 5 of Royal Decree 1659/1998 of 24 July, for the development of Article 8.5 of the Law on the Status of Workers in the field of information worker on the essential elements of the contract of employment, where the information referred to in that article is not included in the written contract of work, in respect of each worker.

b) The receipts of wages of each worker and the proof of payment of wages to each worker.

(c) The hourly records that have been made, with the indication of the beginning, end, and duration of the day of daily work.

(d) The document certifying the authorisation to work for third-country nationals under the law of the State of establishment.

3. Upon completion of the posting, employers shall provide the documents referred to in paragraph 2 where they are required by the Labour and Social Security Inspectorate.

4. Employers shall notify in writing to the Employment Authority, in the terms which they are determined to determine, the damage to the health of the posted workers who would have been produced on the occasion or as a result of the work runs in Spain.

5. The documentation referred to in the preceding paragraphs shall be translated into Spanish or the co-official languages of the territories in which the services are to be provided. "

Four. Article 8 is worded as follows:

" It is up to the Labour and Social Security Inspectorate to monitor and enforce compliance with this law, developing the functions set out in Law 23/2015, of July 21, Computer System of Inspection of Labour and Social Security. The non-compliances will be sanctioned in accordance with the provisions of the recast of the Law on Infractions and Sanctions in the Social Order, approved by the Royal Legislative Decree 5/2000 of 4 August. "

Five. A new Article 8a is incorporated, which is worded as follows:

" 1. In order to implement and ensure compliance with the posting of workers rules, the competent authorities shall carry out a comprehensive assessment of the factual elements deemed necessary, including in particular: Those referred to in paragraphs 2 and 3. The factual elements shall be of assistance to the competent authorities in the checks and checks on compliance with the requirements for movement. These elements are indicative factors in the overall assessment to be made and therefore cannot be considered in isolation.

2. In order to determine whether a company moving workers to Spain develops substantive activities in the Member State of establishment which are not purely administrative or internal management, the competent authorities shall carry out a the overall assessment of all factual elements which, taking into account a broad time frame, characterise the activities carried out by the undertaking in the Member State of establishment and, where necessary, in Spain. Some objective elements to this end may be as follows:

(a) The place where the company has its registered office and its administrative headquarters, occupies office space, pays its taxes and social security contributions and, if applicable, holds a professional license or is registered in chambers of commerce or relevant professional bodies, in accordance with national rules;

b) the place where the displaced workers are hired and the place from which they are displaced;

(c) the right applicable to contracts that the company holds with its employees, on the one hand, and with its customers, on the other;

d) the place where the company performs its core business activity and where it employs administrative staff;

(e) the number of contracts concluded and the turnover made by the undertaking in the Member State of establishment, taking into account the specific situation of, inter alia, small and medium-sized enterprises and the newly created companies.

3. In order to determine whether a worker temporarily posted to Spain performs his job in another Member State, all the factual elements characterising the work and the situation of the worker, including those of the worker, must be examined. The following can be included:

a) If the work is done in Spain for a limited period of time;

b) the start date of the offset;

(c) the Member State in which, or from which, the posted worker to Spain usually performs his or her work, in accordance with Regulation (EC) No. 593/2008 (Rome I) or with the Rome Convention;

(d) if the posted worker returns or is scheduled to return to work in the Member State from which he or she travels, once the work has been completed or the services for which he was posted to Spain have been completed;

e) the nature of the activities;

f) if the employer provides the travel, maintenance or accommodation of the worker to whom they travel or reimburse those expenses, and, if so, how they provide them or how they reimburse them;

g) the periods before the position has been occupied by himself or another posted worker.

4. The absence of one or more of the factual elements set out in the above paragraphs does not necessarily exclude that the situation can be considered a real displacement. The assessment of these elements should be adapted to each particular case and take into account the specificities of the situation.

5. The elements referred to in the preceding paragraphs may also be taken into account by the competent authorities in order to determine whether a displaced person falls within the definition of "posted worker" contained in the Article 2.1.2., to which effect, among other elements, must be guided by the facts related to the performance of the work, the subordination and the remuneration of the worker, independent of how the parties have characterized their relationship in the contract or other type of agreement that they have subscribed to. "

Six. A new paragraph 3 is added, relists as 4 the current paragraph 3 and a new paragraph 5 is added to Article 9, which are worded as follows:

" 3. Cooperation and administrative assistance may also include the sending and reporting of documents.

4. Cooperation and administrative assistance shall be provided free of charge.

5. The processing of personal data that may result in the application of this Law shall be carried out in accordance with the terms laid down in Organic Law 15/1999 of 13 December on the Protection of Personal Data. "

Seven. Article 15 is worded as follows:

" The courts of the social order shall know how many contentious questions are raised in application of this law, in accordance with the provisions of Articles 2 (n) and (2) (t) of Law 36/2011 of 10 October, regulatory of social jurisdiction. "

Eight. Article 16 is worded as follows.

" 1. The Spanish courts of the social order shall be competent to hear the disputes referred to in the preceding article where the worker is or has been temporarily posted in Spain, in accordance with Article 25 of the The Organic Law 6/1985 of 1 July of the Judiciary and without prejudice to the full validity of the competition criteria laid down in Article 21 of Regulation (EU) No 1215/2012 of the European Parliament and of the Council of 12 December 2012 2012, concerning jurisdiction and the recognition and enforcement of judgments in civil and commercial matters, and Article 5.1 of the Convention on jurisdiction and the enforcement of judgments in civil and commercial matters, signed at Lugano on 16 September 1988.

2. The jurisdiction of the Spanish courts of the social order shall be determined in accordance with the rules contained in Chapter II of Title I of Law 36/2011 of 10 October. '

Nine. Article 17 is worded as follows:

"In all that is not foreseen in this section will govern, as a supplementary right, Law 36/2011, of October 10."

Ten. Paragraph 5 of the first provision is amended with the following content:

" 5. For the purposes of Article 20 of Law 23/2015 of 21 July, the authorising officer of the System of Labour and Social Security, the Labour and Social Security Inspectorate may also initiate the procedure of its own motion in the the assumptions referred to in the previous paragraphs under the communication of the public administrations to which the monitoring of the performance of the working conditions corresponds at the place of posting. '

Once. An additional sixth provision is added with the following content:

" Additional disposal sixth. Central electronic record on posting of workers.

For the purposes of Article 5.1, the Ministry of Employment and Social Security and the Autonomous Communities shall draw up a cooperation protocol for the operation of the central electronic register. Such a protocol shall ensure adequate intercommunication and effective establishment within six months. '

Twelve. An additional seventh provision is added with the following content:

" Additional provision seventh. Mutual recognition and assistance in the cross-border notification and enforcement of administrative penalties resulting from non-compliance with the posting of workers.

1. Cross-border notification and enforcement of financial penalties and administrative fines imposed on an undertaking established in a Member State of the European Union or in a State signatory to the Agreement on the European Economic Area, which displaces workers in the framework of the provision of transnational services to another of those States for failure to comply with the applicable rules on the posting of workers, shall be subject to the principles of recognition and mutual assistance and will be carried out through the Internal Market Information System regulated in the Regulation (EU) No 1024/2012 of the European Parliament and of the Council of 25 October 2012 on administrative cooperation through the Internal Market Information System and repealing Commission Decision 2008 /49/EC ("IMI Regulation"), as provided for in the Regulation.

By designating the competent authorities in Spain for the purposes of this provision, the regulatory standard to be approved may provide for the existence of a central authority responsible for the transmission and the administrative reception of the petitions and to assist the competent labour authorities in the notification and enforcement of the penalties.

2. The competent authorities of Spain receiving a request for the notification of a decision or other documents relating to the imposition of an administrative penalty or a fine or a request for payment of the same, transmitted through of the Internal Market Information System as provided for in regulation, shall recognise the administrative penalty and the request for recovery without further formality and shall immediately take all necessary measures for its notification or recovery, unless they invoke the concurrence of any of the following grounds for refusal:

(a) That the investigation carried out by the competent authority clearly shows that the costs or resources necessary for the recovery of the penalty or fine are disproportionate in relation to the amount to be charged or to assume disproportionate difficulties;

(b) the total of the penalty or fine is less than EUR 350;

(c) that the execution of the sanction involves a violation of the fundamental rights and public freedoms of the sanctioned or violated rules of law necessary.

3. The competent Spanish authorities may transmit to the authorities of another Member State of the European Union or of a signatory State of the Agreement on the European Economic Area a request for the notification of a decision by which the imposes an administrative penalty or a fine or a request for recovery of the same in the territory of those States through the Internal Market Information System in accordance with the provisions laid down in law.

4. This provision shall apply to the cross-border notification and enforcement of the following financial penalties or administrative fines, including charges and surcharges:

(a) Those imposed by the competent Spanish authorities or confirmed by the Spanish administrative or judicial bodies responsible for the offences referred to in Article 10 of the recast of the Act on Infractions and Penalties in the Social Order approved by the Royal Legislative Decree 5/2000 of 4 August.

(b) Those imposed by the competent authorities or confirming the administrative or judicial bodies or, where appropriate, emanating from the social jurisdiction of another Member State of the European Union or State signatory to the Agreement on the European Economic Area, in accordance with its rules and procedures, relating to the non-compliance with the respective national rules for the transposition of Directive 96 /71/EC of the European Parliament and of the Council of 16 December, on the posting of workers in the framework of the provision of Directive 2014 /67/EU, of the European Parliament and of the Council of 15 May 2014 on the enforcement of Directive 96 /71/EC on the posting of workers in the framework of the provision of services to the European Parliament and of the Council services, and amending Regulation (EU) No 1024/2012 on administrative cooperation through the Internal Market Information System ('IMI Regulation ').

5. This provision shall not apply to the cross-border enforcement of sanctions falling within the scope of Law 23/2014 of 20 November 2014 on the mutual recognition of criminal decisions in the European Union, and in particular its Title IX on "Resolutions imposing financial penalties".

6. The amounts charged for the implementation of the administrative penalties and fines shall be payable in favour of the Spanish competent authority or of the Member State of the European Union or of the State signatory to the Economic Area Agreement. European that has carried out the execution of the sanction. "

Thirteen. An additional eighth provision is added with the following content:

" Additional disposal octave. Other obligations arising from the legislation of the European Union.

The provisions of Articles 5 and 6 of this Law shall be without prejudice to the fulfilment of the other obligations arising out of European Union legislation, including those arising from Council Directive 89 /391/EEC, 12 June 1989 on the implementation of measures to promote the improvement of the safety and health of workers at work and of Regulation (EC) No 883/2004 of the European Parliament and of the Council of 29 April 2004 on the coordination of social security systems or those arising from the Spanish legislation in respect of the protection or employment of workers who are equally applicable to undertakings established in Spain. '

Fourteen. An additional ninth provision is added with the following content:

" Additional provision ninth. Updating the information.

The Ministry of Employment and Social Security should keep the website of transnational posting of workers contained on the Ministry of Employment and Social Security website as well as information up to date. provided on the country tab on the European Commission's website. "

Fifteen. An additional tenth provision is added with the following content:

" Additional Disposition 10th. Support for the initiatives of the social partners.

Respecting the autonomy of the social partners, adequate support for the relevant initiatives of the social partners can be ensured in order to inform companies and workers about the conditions of employment applicable to the movement of workers within the framework of the provision of services of a transnational nature. "

Item seventh. Amendment of the recast of the Law on Infractions and Sanctions in the Social Order approved by the Royal Legislative Decree 5/2000 of 4 August.

One. Article 2 (11) is amended as follows:

" 11. Employers falling within the scope of the rules governing the posting of workers in the framework of the provision of transnational services in respect of the obligations laid down in that legislation. "

Two. The title of Subsection 3 of Section 1 of Chapter II, which is read as follows, is amended

follows:

"Subsection 3. Infringement Of Obligations laid down in the rules governing the posting of workers to Spain in the framework of the provision of transnational services"

Three. Article 10 (1), (2) and (4) are amended as follows:

" 1. They are minor infractions:

(a) The formal defects of the communication of posting of workers to Spain in the framework of the provision of transnational services, in the legally established terms.

(b) Not to give account, in time and form, to the competent labour authority, in accordance with the provisions in force, of accidents at work and of occupational diseases declared, when they are classified as mild. "

" 2. These are serious violations:

(a) The presentation of the posting of posting after its commencement or without designating either the representative of the company that serves as liaison with the competent Spanish authorities and for sending and receiving documents or notifications, whether from a person who can act in Spain on behalf of the company providing services in the procedures for informing and consulting employees, and negotiation, affecting workers Displaced to Spain.

b) Not to have available in Spain, during the posting, the documentation relating to it, in the legally established terms.

(c) Not to give account, in time and form, to the competent labour authority, in accordance with the provisions in force, of the accidents at work and of the occupational diseases declared, when they are classified as severe, very serious, or fatal.

d) Not to present the documentation required by the Labour and Social Security Inspectorate or to present any of the documents without translating. "

" 4. Without prejudice to the foregoing, it constitutes an administrative infringement not to guarantee workers displaced to Spain, whatever the law applicable to the employment contract, the working conditions laid down by the labour law. in the terms defined by Article 3 of Law 45/1999 of 29 November on the posting of workers in the framework of the provision of transnational services, regulatory provisions for their implementation, and in the collective agreements and arbitration awards applicable at the place and in the sector or branch of the activity in the case of the case, as well as the failure to comply with the obligations referred to in the seventh additional provision of the same law. The classification of such offences, their qualification as minor, serious or very serious, the penalties and the criteria for their graduation shall be in accordance with this law. '

Additional disposition first. The territorial scope of the amendments made by the third and fourth articles in relation to the exercise of actions for damages resulting from infringements of competition law.

The provisions contained in the third and fourth articles of this Royal Decree-law will apply to cases where the exercise of the damages actions is carried out in Spanish territory, irrespective of the fact that the infringement of competition law would have been declared by the European Commission or the Court of Justice of the European Union or by an authority of the Spanish jurisdiction or court or other Member State of the European Union.

Additional provision second. Application of the principles of effectiveness and equivalence in relation to the exercise of actions for damages arising from infringements of competition law.

In terms of damage compensation, the principles of effectiveness and equivalence will apply.

The principle of effectiveness requires that the rules and procedures applicable to the exercise of damages do not make the exercise of the right to compensation for damages practically impossible or excessively difficult. caused by an infringement of competition law.

The principle of equivalence requires the equalisation of the rules and procedures applicable to the exercise of the actions of damages arising from infringements of European law and national competition law, so that the national rules applicable to claims for infringements of European standards are not less favourable to those who are injured than those governing complaints for infringements of national rules.

First transient disposition. Transitional arrangements for actions for damages resulting from infringements of the competition law of the Member States and the European Union.

1. The forecasts contained in the third article of this Royal Decree-Law shall not apply with retroactive effect.

2. The forecasts contained in the fourth article of this Royal Decree-Law shall apply exclusively to proceedings initiated after their entry into force.

Second transient disposition. Implementation of the single European code provided for in Article 34 of the Royal Decree-Law 9/2014 of 4 July 2014 laying down quality and safety standards for the donation, procurement, evaluation, processing, preservation, the storage and distribution of human tissues and cells and the standards of coordination and operation are approved for use in humans, in accordance with the modification introduced by the fifth article of this Royal Decree-Law.

The tissues and cells that have been stored prior to 29 October 2016 shall be exempt from the obligations relating to the single European code referred to in Article 34 of Royal Decree-Law 9/2014 of 4 May 2016. July, laying down quality and safety standards for the donation, procurement, evaluation, processing, preservation, storage and distribution of human tissues and cells and the approval of the coordination and operation for use in humans, provided that they are put into circulation in the European Union within a period of five years from that date, and ensuring full traceability by alternative means.

In the case of tissues and cells which, having been stored prior to 29 October 2016, are kept in storage and are only put into circulation once that five-year period has expired and for the that the application of the single European code is not possible, in particular because tissues and cells are stored frozen at very low temperatures, tissue establishments should use the procedures applicable to the products with small labels set out in Article 34a (f) of Royal Decree-Law 9/2014, of 4 July.

Transitional provision third. Transitional rules on the posting of workers to Spain.

1. The posting of workers to Spain made prior to the entry into force of this royal decree shall be governed by the regulations in force at the time of its implementation.

2. As long as the planned regulatory development is carried out, the travel communications of workers to Spain may continue to be carried out by the means in which they came to the date of entry into force of this royal decree-law.

3. Without prejudice to the provisions of the above paragraphs, the amendments made to Law 45/1999 of 29 November 1999 by the present Royal Decree-Law shall apply to movements which have already begun on the date of entry into force of the Treaty. provided that the posted workers continue to provide services in Spain at that time.

Single repeal provision. Regulatory repeal.

All provisions of equal or lower rank are repealed to be opposed to the provisions of this Royal Decree-Law.

Final disposition first. Amendment of the recast text of the General Law for the Defense of Consumers and Users and other complementary laws, approved by Royal Decree Legislative 1/2007, of 16 November.

The recast text of the General Law for the Defense of Consumers and Users and other complementary laws, approved by Royal Legislative Decree 1/2007 of 16 November, is amended in the following terms:

One. Paragraph 3 is amended to Article 66a, which is worded as follows:

" 3. Where the contract has been terminated, the employer shall, without undue delay, reimburse all the amounts paid by the consumer and user under the contract. "

Two. Article 107 (1) is amended, which is worded as follows:

" 1. The employer shall reimburse any payment received from the consumer and user, including, where appropriate, the delivery costs, without undue delay and in any event before 14 calendar days have elapsed since the date on which he was informed. of the decision to withdraw the contract from the consumer and user in accordance with Article 106.

The employer shall make the reimbursement referred to in the first subparagraph using the same means of payment used by the consumer for the initial transaction, unless the consumer has expressly provided the This is the case, provided that the consumer does not incur any costs as a result of the reimbursement. "

Final provision of the second Incorporation of European Union law.

By this Royal Decree-law the following Directives are incorporated into Spanish law:

Directive 98 /26/EC of the European Parliament and of the Council of 19 May 1998 on the finality of settlement in payment and securities settlement systems, as amended by Regulation (EU) No 648/2012 of the European Parliament and of the Council European Union and the Council of 4 July 2012 on OTC derivatives, central counterparties and trade repositories.

Directive 2013 /50/EU of the European Parliament and of the Council of 22 October 2013 amending Directive 2004 /109/EC of the European Parliament and of the Council on the harmonisation of transparency requirements concerning information on issuers whose securities are admitted to trading on a regulated market, Directive 2003 /71/EC of the European Parliament and of the Council on the prospectus to be published in the event of a public offering or admission to (a) the provision of securities, and Commission Directive 2007 /14/EC laying down detailed rules for the application of certain requirements of Directive 2004 /109/EC.

Directive 2014 /104/EU of the European Parliament and of the Council of 26 November 2014 laying down certain rules governing, by virtue of national law, the actions of damages resulting from infringements of the Competition law of the Member States and of the European Union.

Commission Directive (EU) 2015/565 of 8 April 2015 amending Directive 2006 /86/EC as regards certain technical requirements for the codification of human tissues and cells.

Commission Directive (EU) 2015/566 of 8 April 2015 implementing Directive 2004 /23/EC as regards the procedures for the verification of the equivalence of quality and safety standards for the imported cells and tissues.

Directive 2014 /67/EU of the European Parliament and of the Council of 15 May 2014 on the guarantee of compliance with Directive 96 /71/EC on the posting of workers in the framework of a provision of services, and amending Regulation (EU) No 1024/2012 on administrative cooperation through the Internal Market Information System ('IMI Regulation ').

Final disposition third. Competence title.

The first and second articles of this Royal Decree-law are exercised in the exercise of exclusive powers corresponding to the State in matters of commercial law, as set out in Article 149.1.6. Spanish, bases of the management of the credit, established in Article 149.1.11., and bases and coordination of the general planning of the economic activity, established in the article 149.1.13

The third article is dictated by the provisions of article 149.1.13. of the Spanish Constitution, which attributes to the State the competence of Bases and coordination of the general planning of economic activity.

The fourth article is dictated under the jurisdiction which the State exclusively attributes to Article 149.1. 6. the Spanish Constitution on procedural matters.

The fifth article is dictated by the provisions of article 149.1.16. of the Spanish Constitution, which attributes to the State the competence in the field of bases and general coordination of health, with the exception of its paragraph two that are amenable to the exclusive competence of the State in the field of external health.

The sixth and seventh articles of this Royal Decree-law are dictated under the jurisdiction of the competences provided for in Article 149.1.5. and 7. of the Spanish Constitution, which attribute to the State exclusive powers in the the subject of the administration of justice and labour law, without prejudice to its implementation by the bodies of the Autonomous Communities.

Final disposition fourth. Regulatory enablement.

The Government is enabled to dictate how many provisions are necessary for the implementation and development of this Royal Decree-Law.

Final disposition fifth. Entry into force.

This Royal Decree-law will enter into force on the day of its publication in the "Official State Gazette".

Given in Madrid, on May 26, 2017.

FELIPE R.

The President of the Government,

MARIANO RAJOY BREY