Key Benefits:
Law of 8 February 2007 establishing a new pharmaceutical law
We Beatrix, at the grace of God, Queen of the Netherlands, Princess of Orange-Nassau, etc. etc. etc.
All of them, who will see or hear these, saluut! do know:
In this regard, we have taken the view that it is desirable to modernise legislation in the field of supply of medicinal products, and to adopt a new legislation on medicines for the purpose of the medicinal products sector;
In this way, we, the Council of State, and with the mean consultations of the States-General, have been well-regarded and understood to be right and to be understood by the following:
1 The following shall be understood in this Act and the provisions which are based thereon:
a. Our Minister: Our Minister of Health, Welfare and Sport;
b. 'medicinal product' means a substance or combination of substances which is intended to be administered or used or presented in any way as appropriate for:
1 °. curing or preventing a disease, lack, wound or pain in man,
2. the lodging of a medical diagnosis in man; or
3 °. to restore, improve or otherwise modify physiological functions in humans by achieving a pharmacological, immunological or metabolic effect;
b.1. Advanced therapy medicinal product: a medicinal product as referred to in Article 2 of Regulation (EC) No 1394/2007;
c. immunological medicinal product: a vaccine, toxin, serum or allergen;
d. blood product: a medicinal product prepared from human blood or human plasma;
e. investigational medicinal product: a medicine as specified in Article 1, first paragraph, point (o) of the Medical-Scientific Research Act with people ;
f. homeopathic medicinal product: a medicinal product which, according to a homeopathic manufacturing process, described in accordance with the Treaty on the composition of a European Pharmacopoeia of 22 July 1964, 115, compound European pharmacopoeia or, in the absence thereof, in a pharmacopoeia officially in use in a Member State, is obtained from the raw materials classified as homeopathic medicinal products in the homeopathic pharmaceutical literature raw materials;
g. herbal substance: fresh or dried plants, whole, sliced or broken plants, parts of plants, algae, fungi and lichens, defined by the plant part used and the botanical name according to the binomominal system;
h. Herbal preparation: a preparation which is obtained by subjugating herbal substances to extraction, distillation, exaltation, fractionation, purification, concentration or fermentation;
Herbal medicinal products: a medicinal product which, as active ingredients, contains only one or more herbal substances, one or more herbal preparations or a combination of one or more herbal substances and preparations;
j. biological substance: a substance produced by or extracted from a biological source and whose typing and quality determination can only be done on the basis of a combination of physico-chemical-biological agents. tests in connection with the production process and control of that process;
(k) biological medicinal product: a medicinal product of which the active substance is a biological substance;
l. radiopharmaceutical: a medicinal product containing radionuclide when it is ready for use in a patient;
(m) radionuclide generator: a system containing a bonded parent radionuclide from which a daughter radionuclide is produced which is used in a radiopharmaceutical;
n. kit: a preparation which is constructed or combined with radionuclides into a radiopharmaceutical;
o. radionuclide output: a radionuclide produced for the radiolabelling of another substance prior to its administration;
(p) reference medicinal product: a medicinal product for which a marketing authorisation has been granted in a Member State or by the European Community and referred to in the application to the College for a marketing authorisation;
q. generic medicine: a medicinal product whose composition of the active substances is both qualitatively and quantitatively the same as that of the reference medicinal product, the pharmaceutical form is the same as that of the reference medicinal product, and the biological equivalence of the reference medicinal product in scientific studies on bioavailability has been demonstrated, or is, by its nature, biologically equivalent to the reference product;
Orphan medicinal product: a medicine that Regulation (EC) No 141/2000 of the European Parliament and of the Council of 16 December 1999 (PbEG L 18) on orphan medicinal products as such have been designated;
UR medicinal product: a medicinal product which may only be placed on prescription;
s. 1. UA medicinal product: a medicinal product which may be placed in a pharmacy without a prescription and without a prescription;
t. UAD-medicinal product: a medicinal product which may be put to the service under the supervision of a drugstore without a prescription, but only in a pharmacy or a seller, other than a UA medicine;
you. AV-medicinal product: a medicinal product which may also be placed on the market outside a pharmacy or a seller, under the supervision of a drugstore, without a prescription;
u.1. falsified medicinal product a medicinal product with a false representation of:
1 °. identity, including packaging, labelling, name, composition of constituents, including auxiliary substances, or concentration of constituents;
2 °. origin, including manufacturer, country of manufacture, country of origin, or holder of the marketing authorisation; or
3 °. history, including registries or documents relating to used distribution channels;
v. pharmaceutical form: the physical form in which a medicinal product has been given for the purpose of administration or use in humans;
(w) name of a medicinal product means either an invented name or a general or scientific name, accompanied by a trade mark or the name of the holder of the marketing authorisation;
x. common name: the international name recommended by the world organisation or, failing that, the common name;
x.1. Active substance: a substance or mixture of substances intended to be used in the manufacture of a medicinal product and, consequently, an active ingredient of that medicinal product which is intended to be a pharmacological, immunological or veterinary medicinal product, or to effect metabolic effects, in order to restore, improve or alter physiological functions, to provide a medical diagnosis, respectively;
x.2. Auxiliary substance: Any component of a medicinal product other than the active substance or packaging material;
- Strength: the active substance content, expressed in terms of quantity per dose, volume or weight;
z. bioavailability: the measure of the rate and the amount of an active substance of a medicinal product when it is taken in the circulation;
aa. primary packaging: the packaging that comes directly into contact with the medicinal product;
Bb. outer packaging: the packaging in which the primary packaging is located;
cc. Member State: a State which is a member of the European Union or any other State Party to the Agreement on the European Economic Area;
dd. third country: a country other than a Member State;
ed. preparing the whole or part of the manufacture of medicinal products or the packaging or labelling thereof;
Ff. Batch: a quantity of units of a medicinal product in the same pharmaceutical form or part of a prepared medicinal product in the same physical form, prepared from a homogeneous output mass and has the same set of preparation acts undergoing;
Gg. labelling: the presentation of particulars on the outer packaging or on the immediate packaging;
hh. entering: from a third country entry into the territory of the Netherlands of medicinal products;
i. deliver: otherwise, the supply of medicinal products by the use of medicinal products by hand or by hand;
jj. export: from the territory of the Netherlands to the territory of a third country of medicinal products;
Kk. the conduct of a wholesale trade: the whole of activities consisting of buying, supplying and supplying or performing medicinal products prepared or imported by third parties;
kk. 1. Medicinal products: any activity related to the sale or purchase of medicinal products, other than the float of a wholesale trade, which does not involve any physical treatment of the medicinal products concerned, and which consists of the independent negotiation on behalf of any other natural person or legal person;
ll. to provide the direct supply or delivery of a medicinal product to the patient for whom the medicinal product is intended, or to professionals as referred to in Article 36, 14th paragraph (a) to (d) of the Act on Professions in Individual Health Care , dental hygienists or optometrists who have medicinal products for use in their patients;
mm. Manufacturer: natural or legal person established in the Netherlands to whom Article 18 permit the preparation or introduction of medicinal products and the delivery or execution of medicinal products prepared or imported by him;
nn. wholesaler: the natural or legal person established in the Netherlands to whom Article 18 a licence has been granted for the conduct of a wholesale distribution of medicinal products;
oo. Pharmacy: a local or a coherent set of premises in which medicinal products are prepared, put into service and kept in stock for the purpose of providing them, or are put into storage only and in stock for that purpose Held;
P. (a) a prescription: an occupational practitioner designated by a name and an employment address, as referred to in Article 36, fourteenth paragraph , either of the law referred to in (I) or to a competent professional in another Member State, drawn up in a document in which a person or body as referred to in point (a) is Article 61, first paragraph , a prescription is given to put a drug labelled with its dust name or brand name in the indicated amount, strength and manner of use to an identifiable patient, signed by the relevant patient. professional or, without being signed, a code of code in such a way as to enable an appropriate person or body to establish its authenticity;
qq. 'investigation file' means the file referred to in point Article 1 (p) of the Law on Medical Scientific Research with People ;
Rr. subject: the person, intended in Article 1, first paragraph, point (c) of the Medical-Scientific Research Act with people ;
ss. Adverse reaction: a reaction to a medicinal product that is harmful and unintentional;
Tt. Serious adverse reaction: an adverse reaction leading to death, life danger, hospitalization or renewal of hospital stay required, permanent disability or incapacity for work, or from within a period of time birth defect or malformation;
Uu. unexpected adverse reaction: an adverse reaction of which the nature, severity or effect is not compatible with the summary of the characteristics of the medicinal product, as intended Article 46, first paragraph ;
Misuse of medicines: a deliberate excessive use of medicinal products associated with harmful physical or psychological effects;
I'm Pharmacovigilance: the full range of activities aimed at identifying, assessing and preventing adverse reactions to medicinal products which have been granted marketing authorisation, and the approach to neighbouring medicinal products related to medicinal products problems;
ww.1. periodic safety report: a report, including the summary and scientific evaluation of benefits and risks and all available data of a medicinal product;
ww.2. Post-authorisation safety study: an investigation carried out with an authorised medicinal product to confirm the safety profile of the medicinal product, to identify safety risks, to characterise or to quantify, or to assess the effectiveness of the safety measure risk management measures;
ww.3. Risk management system: the whole of pharmacovigilance activities and interventions to determine, characterising, avoiding or minimising risk of a medicinal product, including the assessment of the effectiveness of such pharmacovigilance activities. activities and interventions;
ww.4. risk management plan: a precise description of the risk management system;
ww.5. Pharmacovigilance system: a system that holds the Marketing Authorisation Holder and the College individually to perform pharmacovigilance tasks and is applied to monitor safety and safety of the pharmacovigilance system. of authorised medicinal products and any changes in the relationship between benefits and risks of those medicinal products;
ww.6. Pharmacovigilance system master file: a detailed description of the pharmacovigilance system used by the holder of the marketing authorisation;
ww.7. European medicines web-portal: the European medicines web-portal established under Article 26 of the Regulation;
xx. 'advertising' means any form of interference with the obvious purpose of promoting the prescription, use of a medicinal product, or the issuing of a medicinal product;
Ijij. public advertising: advertising of a medicinal product which, in view of its content and the way it is being voiced, appears to be intended for others other than professionals as defined by Article 82 (a) , is intended;
Zz. 'award-award' means the provision for the provision, provision or use of funds or goods for the obvious purpose of promoting the prescription, use or use of a medicinal product, with the prospect of proposing, offering or awarding money or to promote the use of a medicinal product;
aaa. meeting: an organised meeting of professionals as defined in Article 82 (a) , which appears to have the sole purpose of promoting their scientific knowledge and knowledge in the field of medicine, pharmacy, dental art, obstart or nursing;
bbb. manifestation: an organized gathering of professionals as intended in Article 82 (a) , the aim of which is to promote the prescripting of medicinal products for the use of medicinal products;
ccc. hospitality: reimbursement of expenses of participation in a meeting or event or in travel and subsistence expenses related to it or not to charge such costs;
Ddd. Teleshopper message: a direct offer to the public in a television programme with a view to the supply of a medicinal product;
Eee. Directive 2001/83 : Directive 2001 /83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use (PbEG L 311);
fff. Regulation 726/2004: Regulation (EC) No 148/EC 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European system for the establishment of a European Community Pharmaceutical Agency (PbEG L 136);
fff.1. Regulation (EC) No 1394/2007: Regulation (EC) No 1394/2007 of the European Parliament and of the Council of 13 November 2007 on advanced therapy medicinal products and amending Directive 2001/83 and Regulation (EC) No 1394/2007 726/2004 (Pb EU L 324);
ggg. Commission: the Commission of the European Communities;
hhh. Agency: the European Medicines Agency established under Article 55 of Regulation 726/2004;
r. The Committee for Medicinal Products for Human Use, established in accordance with Article 5 of Regulation 726/2004;
iii.1. 'Coordination group' means the coordination group for the mutual recognition and decentralized procedure established pursuant to Article 27 of Directive 2001/83;
iii.2. Risk Assessment Committee: the Pharmacovigilance Risk Assessment Committee established under Article 56 of the Regulation;
iii.3. Eudravigilance database means the database and its related data processing network established pursuant to Article 24 of the Regulation;
iii.4. EudraGMP-database: the database and its related data processing network, established under Article 111 (6) of Directive 2001/83.
Yyy. Committee for Herbal Medicinal Products: the Committee established under Article 16h of Directive 2001/83 ;
Kkk. College: the College for the Evaluation of Medicinal Products, set up under Article 2 ;
lll. 'marketing authorisation' means a marketing authorisation for a medicinal product;
mmm. parallel marketing authorisation: a permit granted under the conditions of Article 48, first paragraph ;
nnn. risk associated with the use of a medicine: a risk associated with the quality, safety or efficacy of a medicine for the health of the patient or public health or the risk of unwanted effects on the patient. environment;
Ooo. Consideration of benefits and risks: the trade-off between the therapeutic effect of a medicinal product in relation to a risk referred to in part nnn;
ppp. Accession Act: the Act concerning the conditions of accession for Tjechia, Cyprus, Estonia, Latvia, Lithuania, Hungary, Malta, Poland, Slovenia and Slovakia of 16 April 2003 (PbEG L 236).
qqq. 'drugstore' means the person in possession of a certificate issued to him for a drugstore issued by an organisation designated by Our Minister;
rrr. Assistant 'drugstore': the person holding a certificate of assistant drugstore issued to him issued by the organisation referred to in section qqq.
2 For the purposes of applying to or pursuant to this Law, the provision of an offer to promote the prescription, use or use of a medicinal product shall be equivalent to the manifest objective of the provision of funds or the receive funds that are valuable or receive goods, or accept funds, services or goods in such a way after having made an offer to promote the prescription, use or use of a medicinal product.
3 For the purposes of applying to or pursuant to this Law, the following shall be taken to include:
a. (a) direct delivery or delivery of medicinal products to veterinarians in response to written request for the exercise of their practice;
(b) the supply of medicinal products to the master of a ship which is intended for use in commercial maritime or sea fishing, to the master of a ship which is used for the purpose of supplying medicinal products intended for use in the ship; Article 57 a pharmacist, or of other medicinal products other than those specified in Article 57 by a pharmacist or by a person or legal person as intended by Article 62, first paragraph, point (d) , in so far as such medicinal products are designated by ministerial arrangements.
4 For the purposes of applying to or pursuant to this Law, the salts, esters, ethers, isomers, mixtures of isomers, complexes or derivatives shall be assimilated to the active substances of a generic medicinal product as far as the properties are concerned not significantly different from this point of view as regards the safety or efficacy of the active substances concerned.
For the purposes of this Act, herbal medicinal product shall also include a medicinal product which, as an active ingredient, except one or more herbal substances, one or more herbal preparations, or a combination of one or more herbal substances, is also Herbal substances and preparations containing vitamins or minerals whose safety is guaranteed on the basis of sufficient evidence and the efficacy of the vitamins or minerals is the efficacy of the active herbal ingredients complements with respect to the specified indications.
6 If a product, in so far as it concerns its characteristics, satisfies both the definition of medicinal product and the definition of a product in another statutory scheme, this Act shall apply without prejudice to that product.
This Act does not apply to blood, plasma or blood cells of human origin, other than plasma, which has undergone an industrial process for the preparation of medicinal products. Furthermore, this law does not apply to radionuclides used in the form of sealed sources.
8 The application of the definition of a falsified medicinal product in the case of or under this Act is without prejudice to legislation on intellectual property.
1 There is a College for the evaluation of medicines.
2 The College shall have its seat in a municipality to be determined by our Minister.
3 The Framework Law on self-employed administrative bodies is applicable to the College.
The College shall be composed of a maximum of 17 members, including the President. Members shall be appointed for a period not exceeding four years and shall be eligible for reappointment.
The College shall adopt rules of management. The College shall make public its rules of procedure.
1 The College shall make public the agendas and minutes of its meetings, including the disclosure of commercial confidential information, and its decisions, including minority views and details of votes and justifications.
2 College meetings are public to the extent that they are not about making decisions where commercial confidential data and documents are being addressed.
1 The College is supported by a secretariat, whose officials are appointed by Our Minister, suspended and dismissed.
2 The officials of the Secretariat do not have any financial or other interests in the pharmaceutical industry that may compromise their impartiality. Each year, they shall make a statement on their financial interests.
1 The College is responsible for the following tasks:
(a) the adoption of decisions relating to marketing authorisations and parallel trade permits in accordance with Chapter 4 ;
(b) the taking of decisions on the classification of medicinal products in accordance with Chapter 5 ;
c. Pharmacovigilance in accordance with Chapter 8 ;
(d) implementing regulations of the Council of the European Union, Council and European Parliament, together with the European Parliament, or the Commission of the European Communities relating to tasks assigned to the College by or pursuant to this Act; shall be allocated as well as decisions taken by the Council or the Commission addressed to the College;
e. the work referred to in Article 13m, 2nd paragraph, of the Law Medical Scientific Research with People ;
f. to be part of the Dutch delegation to committees and bodies of the European Union, where appropriate;
(g) to assess, at the request of the competent authority of another Member State, of an application for a marketing authorisation for a medicinal product;
(h) provide scientific advice on pharmaceutical, pre-clinical and clinical trials of medicinal products with medicinal products to the manufacturer or researcher who has proposed to the College to apply for a marketing authorisation;
(i) giving advice on the quality, safety and usefulness of a medicinal product, at the request of a notified body referred to in Article 16 of Council Directive 93 /42/EC of 14 June 1993 concerning medical devices (PbEG L 169) that in a medical device as intended in Article 1 of the Law on Medical Devices is incorporated as an integral part;
(j) result in a request from the Office for information, documents or other forms of information, made pursuant to Regulation 726/2004, to a request from the competent authority of another Member State for such information; done under legislation of that Member State in which it is at or under Directive 2001/83 Some have been converted.
2 In so far as the College is not supported by the Secretariat in the work connected with the assessment of pharmaceutic chemical, toxicological or pharmacological aspects of the application for marketing authorisation, the offered support by the Rijksinstituut for public health and the environment.
Under ministerial arrangements, tariffs are set to cover the cost of fulfillment of the Article 9, first paragraph, points a, b, c, d, g, h, i and j , these tasks.
The College of the Netherlands, on request of the Zorginstitute Netherlands, is intended to Article 58, first paragraph, of the Zorginsurance Act , the information that the institute reasonably requires for forming a judgment in cases where it is heard by Our Minister on an application to designate a drug as belonging to the pharmaceutical concern. (i) entitlement under the statutory social health insurance scheme.
Section 4.1.2 of the General Administrative Law Act shall not apply to decisions of the College giving effect to a decision of the Commission as referred to in Article 34, third paragraph, of the Directive 2001/83 .
1 It is forbidden to prepare or introduce medicines for research without the authorization of our Minister. It is also prohibited to prepare, introduce, supply or export other medicinal products, other than those referred to in the first sentence, without the authorization of our Minister, or to drive them from a wholesale trade. It is also prohibited to conduct a wholesale trade in medicinal products for which no marketing authorisation has been granted.
2 A licence may, in order to ensure compliance with the obligations of the holder of the licence imposed by or under this Law, be subject to rules and restrictions.
3 A permit for the preparation or introduction of medicinal products shall also include a permit for the supply and export of medicinal products which are either self-prepared or imported. Our Minister carries out information relating to manufacturer licensing and wholesale licences in the EudraGMP-database. Our Minister shall also send to the Commission, or to another Member State, the relevant information concerning a licence issued by him for the conduct of a wholesale trade.
4 In the case of ministerial arrangements, detailed rules may be laid down concerning the granting, amendment and revocation of licences as referred to in the first paragraph.
The first paragraph, second sentence, does not apply to the small scale of the preparation of medicinal products for use in pharmacy by or on behalf of a pharmacist, or of a pharmacy in the pharmacy; Article 61, first paragraph, point (b) That is a general practitioner.
6 The first paragraph shall not apply to:
(a) the introduction, execution or otherwise of medicinal products which appear to be intended for their own use by the person transporting the medicinal products concerned within or outside the territory of the Netherlands;
(b) the introduction of medicinal products by a manufacturer, wholesaler or pharmacist if the State control application has granted a derogation to its application for public health purposes in order to comply with a request from a doctor for a veterinary medicinal product. special purpose specified in the derogation.
7 The prohibition in the first sentence of the first sentence shall not apply to bereidation operations in respect of an investigational medicinal product prior to use by patients in the context of a medical-scientific examination as Intended in Article 1, first paragraph, point (b) of the Law on Medical Scientific Research with People in an institution as specified in the Health care institutions Act in which a pharmacist is involved in the preparation for use or administration of the relevant investigational medicinal products for the purpose of use or administration to subjects.
1 For the treatment of an application for authorisation as intended Article 18, first paragraph, first or second sentence , or a change thereof, the applicant is owed a fee to Our Minister.
2 The holder of a licence as referred to in the first paragraph shall be subject to an annual fee to Our Minister.
3 The amount of the fees referred to in paragraphs 1 and 2 shall be determined by ministerial order and may be determined by category of licences, including variations to authorizations, or of medicinal products. Where a licence is valid for a period of less than one year, the fee referred to in paragraph 2 shall be fixed proportionately.
Except where application is given to: Article 4: 5 of the General Administrative Law Act , Our Minister shall inform the applicant within 90 days of the receipt of the application for authorisation as intended Article 18, first paragraph, first or second sentence , in knowledge of his decision.
1 An authorisation for the preparation or introduction of medicinal products shall be granted if the applicant is responsible for the particulars and documents concerned. Article 25 , has submitted and demonstrated that it will be fulfilled Articles 27 , 28 and 29 .
2 A licence for the conduct of a wholesale trade shall be granted if the applicant is responsible for the particulars and documents referred to in Article 2 (2). Article 25 , has submitted and demonstrated that it will be fulfilled Articles 36 and 37 .
A licence shall lapse if:
(a) the legal person to whom the authorisation has been granted shall be dissolved, merged and not the acquiring legal person, or shall be split;
(b) The person to whom the authorization is granted has notified to our Minister in writing that he ceased to carry out the work for which the licence was granted.
1 A licence may be withdrawn if:
(a) the holder of the authorization does not comply with any obligation imposed by or under this Chapter or any requirement or restriction attached to the authorisation;
(b) The person to whom the authorization is granted has ceased to carry out the work in respect of which the authorization was granted.
2 A licence shall not be withdrawn if an administrative penalty has already been imposed on the offender in respect of the same conduct.
1 If a licence is withdrawn following a notification by the competent authority of another Member State which is the holder of a licence as referred to in Article 18, first paragraph, first or second sentence Our Minister shall make such a decision to the competent authority of the other Member State, to the European Commission and to the European Commission, to the competent authority of the other Member State, to an obligation imposed by or under this Chapter or to a requirement or restriction attached to the authorization. the Office.
2 If, following such notification, our Minister decides not to take measures with regard to the holder of the licence, the competent authority of the other Member State, the European Commission and the Office shall be informed of the reasons for that decision.
The following documents shall be submitted when an application for authorization for the preparation or introduction of medicinal products is submitted, or for the conduct of a wholesale trade:
a form to be made available for that purpose by our Minister, which has been completed by the applicant;
b. The documents indicated on the form;
c. a permission to Our Minister to charge a fee as referred to in Article 19, second paragraph , to be recovered in cases where such reimbursement is due.
1 The manufacturer shall not make any changes to any of the facts or circumstances described in the documents provided by the manufacturer without the authorization of Our Minister, as provided for in Article 25 (a) or (b) .
2 Our Minister shall inform the manufacturer as soon as possible, but no later than 30 days after receipt of the application for authorisation as provided for in paragraph 1 of this Decision. If the change relates to business premises, technical equipment or control options, that period may be extended to 90 days.
3 Our Minister may, at the request of the manufacturer, one not in Article 25 designate a certified laboratory designating controls as intended Article 28, first paragraph, b, c or e , may be carried out, if:
a. The laboratory shall have the premises and equipment suitable therefor;
b. the checks are carried out by or on behalf of a person meeting the in Article 29 appropriate professional competence requirements.
1 The manufacturer shall ensure that the preparation of medicinal products is carried out in accordance with the rules to be adopted under ministerial arrangements concerning good manufacturing practice of medicinal products.
2 The manufacturer shall ensure that only active substances manufactured and marketed are used in accordance with the rules for good manufacturing practice of active substances to be established by Ministerial Regulation; (i) provisions on good distribution practice of active substances. Detailed rules for this purpose shall be laid down by ministerial arrangements.
The manufacturer shall only use auxiliary substances suitable for use in medicinal products. Detailed rules for this purpose shall be laid down by ministerial arrangements.
1 The manufacturer shall verify the authenticity and quality of the active substances and excipients he uses.
The manufacturer shall immediately report any information or suspicions of any falsification of medicinal products to the State Supervision of Public Health and the relevant Marketing Authorisation Holder.
1 The manufacturer is responsible for one or more persons with the task:
(a) to ensure that the preparation of medicinal products is carried out in accordance with the relevant provisions of Article 27 rules laid down;
(b) ensure that the preparation of each batch of medicinal products, non-investigational medicinal products, and the quality control thereto are in accordance with the requirements laid down in the dossier on the basis of which the The marketing authorisation shall be granted;
(c) in the case of the importation of medicinal products, non-investigational medicinal products: to ensure that each charge undergoes such qualitative and quantitative analyses, tests and controls, and the quantitative analyses of all the products concerned; including active substances, ensuring that the quality of the medicinal products is in accordance with its description in the dossier on the basis of which the marketing authorisation has been granted;
(d) If a batch of medicinal products, other than pharmaceutical products, is ready to be marketed, on the basis of the report provided for in paragraph 2 and the documents provided for in the second paragraph of this Article. Article 30, first paragraph, points (a) and (b) , or, in the case of import, on the basis of the documents provided for in Article 30, second paragraph, point (a) , sign a document stating that the batch satisfies the requirements set out in subparagraph (c) below;
e. to ensure that the preparation of each batch of investigational medicinal products and their quality control is in accordance with the requirements set out in the product specification and in the research dossier;
f. if a batch of investigational medicinal products has been prepared or imported for examination, on the basis of the report referred to in paragraph 2, to sign a document stating that the charge meets the requirements set out in paragraph (e);
g. to ensure that safety features are defined as Article 69, first paragraph , shall be placed on the packaging of medicinal products intended for placing on the market.
2 The manufacturer shall ensure that the persons referred to in paragraph 1 properly exercise the tasks with which they are entrusted and report their findings in the implementation of these tasks.
3 If the manufacturer is a natural person who satisfies the requirements of Article 29 The obligation to impose such professional competence on the tasks referred to in paragraphs 1 and 2 shall not apply to others.
4 The obligation to carry out the analyses, tests and inspections referred to in point (c) of the first paragraph shall not apply where tests, analyses and controls are carried out in the third country in which the medicinal product has been prepared. An agreement has been concluded between the European Community and the third country and that each of the Parties shall ensure that the rules governing good manufacturing practice of medicinal products are equivalent to those applicable to the other Contracting Parties. acknowledges. Our Minister shall ensure that such agreements are published in the Official Journal.
5 The first paragraph (d) under (f) does not apply to the partial preparation of a medicinal product.
6 Batches of medicinal products designated under ministerial arrangements and prepared or imported into the Netherlands shall be delivered first after a person or body designated by a ministerial arrangement has established that the medicinal products which have been designated by a ministerial arrangement have been identified as having been paragraphs (b) and (c), under the conditions referred to in point (e), are fulfilled. The rules shall lay down rules on the data to be submitted for the purpose of carrying out an investigation as referred to in the first sentence and in respect of compensation due for the execution of such research. The level of compensation may be determined differently for different categories of medicinal products.
Those responsible for the tasks in question Article 28, first paragraph , carry out, comply with requirements to be laid down by ministerial arrangement with regard to their professional competence.
1 The manufacturer shall ensure that in respect of each batch of medicinal products, non-medicinal products for examination, which he prepares:
(a) a numbered protocol shall be kept showing that the preparation has been made in accordance with the procedure laid down in the file on the basis of which the marketing authorisation was granted;
(b) numbered protocols shall be kept showing that all the analyses, tests and checks carried out on the components used for the preparation and on the medicinal product itself have been carried out in accordance with the conditions laid down in the dossier on the basis of which the the marketing authorisation has been granted, described analysis and control methods;
c. any quantity of samples shall be taken to ensure that the quality of the medicinal product and its constituents can be adequately controlled.
2 The manufacturer shall ensure that he/she ensures that, in respect of each batch of medicinal products, non-medicinal products for examination, he imports:
(a) holds a copy of the protocols certifying that the preparation and verification in the third country has been done in accordance with the requirements set out in the dossier on the basis of which the marketing authorisation is to be obtained. issued and maintained by the person who prepared the medicinal product in the third country;
b. has sufficient samples to carry out analyses, trials and controls as specified in Article 28, first paragraph, point (c) , to be able to perform.
3 The manufacturer which packages and label medicinal products, other than medicinal products, prepared and labelled in another Member State from or from a third country is in possession of a copy of the document referred to in Article 3 (1) of this Regulation. Article 28, first paragraph, point (d) , and of the report of analyses, tests and checks carried out on imported medicinal products drawn up and signed by the person in charge of the relevant in the Member State concerned. Article 28, first paragraph , these tasks.
4 The manufacturer shall ensure that, in respect of each batch of investigational medicinal products he is importing, he holds a copy of the protocols certifying that their preparation and the verification thereof in the third country is country has been made in accordance with rules equivalent to the relevant under Article 27 the requirements laid down, and in accordance with the requirements set out in the product specification and the investigation file.
5 If an investigational medicinal product which has already been granted a marketing authorization for comparison and for which a marketing authorisation has already been granted, the manufacturer shall not have documents indicating that each batch has been prepared in accordance with rules equivalent to the relevant under Article 27 the manufacturer shall ensure that checks, tests and analyses are carried out that are necessary to ensure that the quality of the relevant investigational medicinal products is in conformity with the requirements, Intended in Article 28, first paragraph, point (e) .
1 The manufacturer shall keep the document referred to in Article 28, first paragraph, point (d) or (f) , the protocols referred to in Article 30, first paragraph, point (a) and (b), second paragraph, point (a) and (4th) , as well as the report and the document referred to in Article 30, third paragraph , up to a year after the date on which the suitability for use of the medicinal products covered by the relevant batch has expired, but not less than five years from the date on which the relevant documents have been drawn up.
2 The manufacturer shall keep the samples specified in the Article 30, first paragraph, point (c) and second paragraph, point (b) , in a proper manner and in such a package that it cannot be opened without any obvious damage. The manufacturer shall also keep the protocols relating to the relevant samples. The period during which these samples and protocols are to be kept shall end on the date on which the suitability for the use of the sample is terminated as a medicinal product.
The manufacturer shall ensure that the primary packaging or the outer packaging of such a buckle provides that the opening of the packaging leads to visible damage to it.
If the manufacturer delivers medicinal products to those who put it on hand, he shall ensure that it can be traced through the batch number to which it belongs, up to and including those to whom he has delivered.
1 Medicinal products are delivered by the manufacturer only to other manufacturers, wholesalers and to those who are competent to provide the medicinal products concerned.
2 By way of derogation from the first paragraph, investigational medicinal products shall be delivered by the manufacturer only to:
a. Those who conduct a medical-scientific research as intended Article 1, first paragraph, point (f) of the Law on Medical Scientific Research with People , and dispose of a pharmacy in which a pharmacist is employed;
b. A pharmacist who is registered in the register of established pharmacists as intended for Article 61, fifth paragraph , and those carried out by the person carrying out an investigation as referred to in point (a), other than on the basis of a service, is involved in that investigation.
1 The wholesaler shall not, without the authorization of Our Minister, make any changes to the facts or circumstances described in the documents which it provides, which is intended to be Article 25 (a) and (b) .
2 By way of derogation from Article 20 , Our Minister shall inform the wholesaler as soon as possible, but no later than 30 days after receipt of the application for authorisation of a change which does not concern storage or distribution rooms, of its decision.
1 The wholesaler shall ensure that the purchase, storage and marketing of medicinal products is carried out in accordance with the rules to be adopted under ministerial rules on good distribution practices for medicinal products and acts in accordance with Articles 80 and 82 of Directive 2001/83. In order to carry out this task, he shall have a person who has successfully completed an accredited training for that purpose.
2 The wholesaler also ensures that it has an assortment of medicinal products in such a way that it can quickly satisfy the demand for medicinal products from those who are authorized to use medicinal products. -
3 The first paragraph, second sentence, shall not apply where the wholesaler is a natural person who is himself qualified to carry out the task referred to in the first paragraph, and shall do so.
4 If the wholesaler is not also the holder of the marketing authorization, he shall inform the holder of the marketing authorisation and the competent authority of the Member State of destination of its intended wholesale activities. Where the marketing authorisation has been granted pursuant to Regulation 726/2004, it shall also inform the Agency accordingly.
1 The wholesaler is subject to the existence of a falsified medicinal product by the safety features of the product concerned. Article 69, first paragraph , to be checked in accordance with rules to be laid down by Ministerial Regulations.
2 If the wholesaler identifies a falsified medicinal product, at least a suspicion that there is a falsified medicinal product, it shall immediately inform the State Public Health and the Marketing Authorisation Holder thereof. Knowledge.
3 Medicinal products are only delivered by the wholesaler to other wholesalers and to those who are competent to provide the medicinal products concerned.
1 It shall be prohibited to prepare, enter, supply, export or market active substances without registration.
Registration as referred to in paragraph 1 shall be made by means of registration in a register kept by Our Minister by means of a registration form to be made available by Our Minister. The registration and access to registration data for the implementation of Directive 2001/83 are subject to detailed rules under the Ministerial procedure.
1 Our Minister confirms the date of receipt of the registration form intended in Article 38, second paragraph .
2 The manufacturer or wholesaler of active substances does not commence previously with an activity as referred to in Article 38, first paragraph , then 60 days after the date of receipt, referred to in the first paragraph.
3 Without prejudice to the provisions of Chapter 11 of this Act, the State Supervision of Public Health may carry out an inspection on the basis of a risk assessment in response to the registration form referred to in paragraph 1. In the event that the latter is decided upon, our Minister shall inform the manufacturer or wholesaler of active substances thereof within 60 days of the date of receipt referred to in paragraph 1. By way of derogation from the second paragraph, the manufacturer or wholesaler shall not commence the activity concerned after the express consent of our Minister.
1 The manufacturer or wholesaler of active substances shall ensure that the preparation, import, delivery, export or marketing of active substances is carried out in accordance with the good rules to be laid down in the Ministerial Regulations. manufacturing practice of active substances, subject to the rules on good distribution practice of active substances.
The manufacturer of active substances shall respect the provisions of Article 46b, second and third paragraphs of Directive 2001/83 on the importation of active substances.
3 The provisions of paragraph 2 may be waived by our Minister in accordance with rules to be laid down by ministerial rules.
1 The manufacturer or wholesaler of active substances shall annually submit to our Minister a summary of amendments which have taken place in the information which he has provided on registration.
2 By way of derogation from the second paragraph, the manufacturer or wholesaler of active substances shall immediately inform our Minister of any change which may have an effect on the quality or safety of the active substances concerned.
If the manufacturer or wholesaler of active substances does not comply with the provisions of this Chapter, our Minister may, in accordance with the provisions of this Chapter, be registered in the Article 38 -We're going through.
1 It is prohibited to mediate any medicinal product without registration.
2 Registration as referred to in paragraph 1 shall be made by registration in a register kept by Our Minister by means of a registration form to be made available by Our Minister. The registration and access to registration data for the implementation of Directive 2001/83 are subject to detailed rules under the Ministerial procedure.
1 Without prejudice to the provisions of Chapter 11 The mediator, acting under the first paragraph of Article 85b of Directive 2001/83, considers that the rules relating to good distribution practice in respect of medicinal products are to be established by means of a ministerial arrangement.
2 If the mediator does not comply with the provisions of the first paragraph, Our Minister may register, intended to Article 39, second paragraph -We're going through.
1 It is prohibited to place a medicinal product on trade without a Community trade permit granted under Regulation 726/2004 or under that Regulation in conjunction with Regulation 1394/2007, or of the College, granted under this Chapter.
2 It shall be prohibited to have in stock, sell, supply, carry, import or otherwise bring into or outside the territory of the Netherlands a medicinal product for which no marketing authorization is applicable.
3 A prohibition as referred to in the first or second paragraph shall not apply:
a. on medicines taken by or on behalf of a pharmacist or a general practitioner, as intended by Article 61, first paragraph, point (b) , in the small scale of his pharmacy, are prepared and put to the service;
b. investigational medicinal products;
c. on medicinal products delivered after prior authorisation by the State Government on public health, and in accordance with rules to be determined by ministerial arrangement, following an order made at the initiative of a doctor; which are intended for use by individual patients of that doctor under his supervision and which are either prepared in accordance with specifications or in another Member State or in a third country and which have been imported at his request, or otherwise have been brought within the territory of the Netherlands;
d. On advanced therapy medicinal products prepared with the consent of the State Public Health, according to a prescription for an order made drug that for a given patient is prepared on a non-routine basis, according to specific quality standards and be used within the same Member State in a hospital under the exclusive professional responsibility of a doctor;
e. if the medicinal product is subject to a parallel marketing authorisation by the College, as provided for by Article 48 was granted;
f. where it concerns a medicinal product for which either an application for marketing authorization has been submitted to the Agency or is subject to clinical trials and is available in accordance with conditions to be laid down by ministerial arrangement has been put for use in harrowing cases as referred to in Article 83 of Regulation 726/2004;
g. if our Minister has waived a natural or legal person designated by the waiver for marketing a medicinal product with a view to the distribution of an exemption from our Minister for the purpose of exemption from the exemption of the designated pathogen, toxic agent, chemical agent or nuclear radiation which may be harmful to public health, shall be the subject of a period of derogation specified in the derogation;
h. if it concerns a medicinal product imported or exported by a manufacturer or from another Member State, by a wholesaler.
4 It is also prohibited to place generators of radionuclides, kits, precursors for radiopharmaceuticals and industrially prepared radiopharmaceuticals without marketing authorization.
5 If a medicinal product will be placed on the market under the same name in more than one pharmaceutical form or in different quantitative compositions, a separate authorization for each form and composition shall be required. To make permits separately granted for the purposes of this Act, except for: Article 54 , part of the marketing authorisation granted for the medicinal product.
If a medicinal product is placed on the market in a pharmaceutical form to be pooled with a liquid and on the package or in the package insert for use or use different concentrations which are have different qualitable effects, a separate licence shall be required for each concentration.
7 It is prohibited to act in respect of medicinal products for which a marketing authorization has been granted by the Community, in breach of Article 16, first or second paragraph, 23 or 24, first, second, third or fifth paragraph, first and second subparagraph, of Regulation 726/2004.
8 The State Supervision shall ensure that in the preparation of an advanced therapy medicinal product referred to in paragraph 3 (d), the requirements for traceability, pharmacovigilance and quality of the product shall be equivalent to: those which apply to the preparation of medicinal products for advanced therapies for which a marketing authorisation is required by Regulation 726/2004.
1 Without prejudice to the second paragraph, except for the State of the Netherlands, no one can be held liable for the damage to the health of a person if Our Minister uses a medicinal product for an indication which is not included in the dossier on the basis of which the marketing authorisation has been granted or of a medicinal product which is not subject to a marketing authorisation has recommended, or has therefore requested, an urgent request, in order to ensure that the spread of the product concerned is alleged or found. a pathogen, a toxic agent, a chemical agent or a nuclear radiation which may be harmful To combat it, to combat public health.
2 The State of the Netherlands is not liable for the damage of the use of a medicinal product on the basis of the provisions of the first paragraph, to the extent that liability for the medicinal product in question applies to the use of the medicinal product in question, as regards the use of a medicinal product. Articles 185 to 193 of Book 6 of the Civil Code .
1 The marketing authorisation shall be granted by the College only upon application by a natural or legal person established in the Netherlands or in another Member State.
2 The information and documents shall be determined by ministerial procedure and shall be drawn up on the application and drawn up and signed by experts to be determined by the scheme. The rules may be used to distinguish between categories of medicinal products to be communicated and to a modest distinction between categories of medicinal products. Pharmaceutical, preclinical and clinical information is part of the data to be provided and modest.
3 The applicant is not required to submit pre-clinical and clinical data where the application relates to homeopathic medicinal products which meet the following conditions:
a. The means of use is for oral or external use,
b. Neither in or on its package nor in the package leaflet is mentioned of any therapeutic indication; and
c. The degree of dilution shall be such that the product is guaranteed to be harmless and in any case no more than one part per 10 000 of the primal tincture or one hundredth of the smallest dose used in allopathic medicine substances that are present in an UR medicinal product.
4 Without prejudice to paragraph 2, special rules may be laid down in ministerial arrangements with regard to homeopathic medicinal products other than those referred to in the third paragraph, with regard to the presentation of preclinical and clinical conditions. data and documents.
5 Without prejudice to the law relating to the protection of industrial and commercial property, the applicant shall not be required to submit the results of pre-clinical and clinical trials if:
(a) shows that the medicinal product to which the application relates is generic in relation to a reference product for which a marketing authorisation has been granted in the Community for at least eight years before the date of application;
(b) using appropriate scientific literature to provide evidence that the active substances of the medicinal product subject to the application are already used in medical practice for at least 10 years in the Community and a to provide scientifically recognised efficacy and an acceptable level of safety in accordance with the conditions set out in Annex 1 to this Regulation Directive 2001/83 , or
c. It is an application for a medicinal product with the same qualitative and quantitative composition in active substances and with the same pharmaceutical form as the reference medicinal product and the applicant with the consent of the holder of the the marketing authorisation for the reference medicinal product uses the pharmaceutical, pre-clinical and clinical documentation included in the dossier on the basis of which the marketing authorisation was granted.
6 If the application concerns a medicinal product:
a. which does not comply with the definition of generic medicine,
b. The biologic equivalence of which cannot be demonstrated by scientific studies on bioavailability,
c. of which the concentration, pharmaceutical form or method of administration is modified in relation to that of the reference medicinal product; or
d. The active substances or therapeutic indications of which are modified in relation to the reference medicinal product,
The applicant for the marketing authorisation in terms of preclinical and clinical data and documentation shall be sufficient to provide the results of pre-clinical or clinical trials with a view to the difference with those of the relevant the reference medicinal product must be bridged.
7 If, in the application for a marketing authorization, the reference medicinal product is a biological medicinal product and the medicinal product for which the marketing authorisation is claimed is biologically equivalent to the reference product but not on the same basis way is prepared if the reference medicinal product or does not use the same raw materials, the applicant shall be required to carry out the results of preclinical and clinical trials on the relevant aspects of the medicinal product. differs from the reference product, to be submitted. Such additional information as regards number and nature of compliance with the relevant criteria referred to in Annex 1 to this Regulation shall be fulfilled. Directive 2001/83 and to the relevant guidelines adopted by the Commission pursuant to that Directive.
8 Without prejudice to the right relating to the protection of industrial and commercial property, the applicant shall not submit clinical and pre-clinical data if the application relates to a herbal medicinal product which meets the following conditions:
a. the means has indications that only apply to a herbal medicinal product designed and designed as a medicinal product for its purpose and intended for use as a medicinal product designed and designed for use without medical intervention,
b. The product is intended solely for the purpose of being administered at a specified concentration and dosage,
c. It is a means of oral or external use or inhalation use,
(d) the product or equivalent or similar means of use for at least 30 years prior to the date of application for marketing authorization in medical practice, of which at least 15 years have been used in the marketing year of the Community,
e. sufficient data are available to show that the product is traditional and is harmless; and
f. through the long-term use and experience gained from it, it is likely that the product has a pharmacological effect or is otherwise effective.
9 If a medicinal product contains active substances contained in medicinal products which have already been authorised for marketing, but which have not previously been pooled for therapeutic purposes in a single medicinal product, the application for a medicinal product shall be submitted for The results of the new pre-clinical or clinical trials in respect of the aggregation have been submitted. The submission of the documentation relating to the active substances can be omitted separately.
1 The College shall, upon receipt of a request from the competent authority of another Member State to whom an application for a marketing authorization for a generic medicinal product has been submitted, send a notice of confirmation within one month if it is in favour of the application of the marketing authorisation. the reference medicine mentioned in the Netherlands has been granted a marketing authorisation, together with the composition of the reference product and other information deemed to be relevant by the College.
2 A medicinal product for which the use of Article 42, fifth paragraph, point (a), (sixth) and (7) , a marketing authorisation has been granted, it shall not be marketed before the expiry of a period of 10 years following the date on which the marketing authorisation for the reference medicinal product has been granted. This period of protection for the reference medicinal product shall be extended to a maximum of 11 years if the marketing authorisation for the reference medicinal product:
a. Within a period of eight years after it has been granted, in the case of a decision of the College, the competent authority of another Member State or the European Commission, a new indication which may be regarded as an important one. clinical benefit in relation to existing indications, or
b. In the case of a decision of the College, the competent authority of another Member State or the European Commission is enlarged by a new indication for a known substance and with regard to the new indication the necessary preclinical and Clinical trials have been conducted.
1 The College confirms receipt of an application for a marketing authorization or a supplement thereto as intended. Article 4: 5 of the General Administrative Law Act , in writing within a week.
2 The College shall take a decision on whether a marketing authorisation is granted within 210 days of receipt of an application. That period shall be suspended for a period specified by the College within which the applicant has the opportunity to submit additional information requested by the College.
3 In the case of a ministerial arrangement, rules shall be laid down for the purposes of the temporary or simultaneous granting of a marketing authorization for the same medicinal product in more than one Member State, with regard to the rules to be used by the applicant and the College. follow procedure. The 210-day period referred to in the second paragraph shall not apply.
When an application for marketing authorization has been submitted to the College and the College finds that an application for marketing authorization for the same medicinal product has already been applied in another Member State, it shall cease to be treated and communicated the applicant shall inform the Commission that the procedure referred to in the third paragraph shall apply.
5 If the application concerns a medicinal product which has already been granted a marketing authorization in another Member State and the application has not been submitted in accordance with the procedure referred to in paragraph 3, the College shall reject the application.
6 Except where applicable Article 79 The College shall, in cases referred to in Articles 30 (1) and 31 (1) of Directive 2001/83, refer an arbitration procedure to the Pharmaceutical Committee. The College shall be in accordance with Articles 31 to 34 of this Directive.
7 The applicant for or holder of a marketing authorization may also refer the arbitration procedure referred to in paragraph 6 if it considers that a situation such as that for the medicinal product for which such marketing authorization is granted is to be considered as is applicable in that paragraph.
1 The College grants a marketing authorisation for a drug, other than a herbal medicine as intended in Article 42, eighth paragraph If, after examination of the information submitted and records, it appears that:
a. The consideration of benefits and risks is beneficial,
(b) the medicinal product has its therapeutic effect;
(c) the medicinal product has the declared qualitative and quantitative composition; and
(d) the information or documents provided in support of the application shall be in accordance with the provisions of this law.
2 The College grants a marketing authorisation for a herbal medicine as intended Article 42, eighth paragraph ,-the marketing authorisation for a traditional herbal medicinal product (hereinafter referred to as the marketing authorisation), if the following tests show that:
a. to the conditions specified in Article 42, eighth paragraph , is satisfied,
(b) the product is harmless under normal conditions of use,
(c) the product has pharmacological effects or has an efficacy,
d. pharmaceutical quality has been adequately demonstrated and
e. the product is not a homeopathic medicinal product as intended in Article 42, third paragraph It is concerned.
3 The applicant or holder of a marketing authorization shall be responsible for the accuracy of the particulars and documents submitted.
4 In its assessment of an application for a marketing authorisation for a traditional herbal medicinal product, Community herbal monographs and, if necessary, marketing authorisations for herbal medicinal products have been drawn up by the Committee on Veterinary Medicinal Products. like those which are similar to those granted in another Member State.
5 The College shall inform the Commission, as well as the competent authority of another Member State, of a decision which it has taken to refuse a marketing authorisation for a traditional herbal medicinal product.
1 The College may attach to the marketing authorization laid down by Ministerial Regulations. The College shall always inform the Office.
2 For the purposes of implementing the Directive, detailed rules shall be laid down under a ministerial arrangement on the conditions to be met in order to obtain the marketing authorization and the rules which the College may have to comply with the marketing authorization. connect.
1 In exceptional circumstances, the College may grant a conditional marketing authorization, under which conditions the permit may be granted, and which requirements may be subject to the authorization. connected. The College shall always inform the Office.
2 The renewal of a marketing authorisation as referred to in the first paragraph shall be linked to an annual re-evaluation.
1 The College shall draw up an assessment report in respect of the medicinal product in question and shall decide on the application for the marketing authorisation, subject to the rules to be laid down by ministerial rules.
2 Where the marketing authorisation is granted, it shall also include the approval of the summary of product characteristics.
3 As regards access to decisions and documents from the College for the purposes of State supervision of public health, the Office or the public shall be subject to the rules of ministerial order.
1 A marketing authorisation shall be valid for five years, without prejudice to the third and fourth members.
2 The marketing authorisation holder shall submit to the College a consolidated version of the file relating to the quality, safety and efficacy of the marketing authorisation at least nine months before the expiry of the marketing authorisation. the medicinal product, which includes:
(a) changes made since the marketing authorisation has been granted; and
b. Assessment of reports of suspected adverse reactions and periodic safety reports which have been reported in accordance with Chapter 8 of this law have been submitted.
3 After consideration of the benefits and risks, the College shall extend the marketing authorisation for an indefinite period of time, or once for a period of five years, if the pharmacovigilance of the medicinal product or the lack of patients is not sufficient for the duration of the marketing authorisation. medicinal product concerned has been exposed.
4 If a medicinal product has not actually been placed on the market or has been placed on the market for three consecutive years, the marketing authorisation concerned shall lapse. In exceptional circumstances, the College may, for reasons of public health, maintain the marketing authorisation.
1 The College grants, on application, a parallel marketing authorisation within 45 days if the medicinal product to which the application relates is from another Member State and is equal to or substantially the same as a reference product for which the College has granted a marketing authorisation.
2 A parallel marketing authorisation applies to the same indications, contra-indications, adverse reactions, posology, method of use and administration of the reference medicinal product. It according to Article 46, first paragraph , adopted decision to approve the summary of the characteristics of the reference medicinal product, shall also apply to the medicinal product for which the parallel marketing authorisation concerned has been granted.
3 The College suspends a parallel marketing authorisation as long as the marketing authorisation for the reference medicinal product has been suspended.
4 The College draws up a parallel marketing authorisation as soon as the marketing authorization for the reference medicinal product is withdrawn, other than at the request of the holder, or expiring no later than.
5 The holder of a parallel marketing authorisation shall without delay inform the holder of the marketing authorisation of the reference medicinal product that it has been granted a parallel marketing authorisation by the College.
6 After revocation of the trade permit for the reference medicine at the request of the holder, the parallel trade permit remains in effect, unless the College decides that the drug in trade is a real danger to the market. Health of persons is created.
7 If the application relates to a medicinal product protected by patent law or by means of a supplementary protection certificate in the Netherlands, which is covered by Estonia, Hungary, Latvia, Lithuania, Poland, Slovenia, Slovakia or Slovenia; The Czech Republic and before that such protection could not be obtained in the new Member State concerned at the time of registration of the patent or supplementary protection certificate, shall be applied to the application for a parallel marketing authorisation. also presented a copy of the written notification to the holder of the patent or supplementary protection certificate or the beneficiary of that protection in respect of the reference medicinal product showing that the notification was made at least 1 month prior to the day on which the application was submitted.
1 The holder of the marketing authorization shall, subject to the prior consent of the College, amend the methods of preparation of a medicinal product and check it if it is intended to bring the medicinal product into line with the requirements of the methods of scientific and technical progress and the adaptation of the documents submitted in the application for marketing authorisation in relation to the methods.
2 The Marketing Authorisation Holder shall ensure the adaptation of the product information to current scientific knowledge, including the conclusions of assessments and recommendations made publicly available through the European Web Portal of medicinal products.
3 The Marketing Authorisation Holder shall immediately inform the College of any new information which may lead to amendment of the particulars and documents referred to in Article 3 (2). 42, second paragraph , and in Annex 1 to Directive 2001/83 .
4 The Marketing Authorisation Holder shall immediately inform the College of any prohibitions and restrictions imposed by the competent authorities of other Member States as well as any other new information on the consideration of the advantages and benefits of the risks of the medicine may be affected. The information concerns both positive and negative results of clinical trials or other examinations for indications and populations, whether included in the marketing authorisation, as well as data on the use of the medicinal product in derogation from the requirements of the marketing authorisation.
5 The marketing authorisation holder shall, at any time, at the request of the College, provide information showing that the risk-benefit balance of the medicinal product remains favourable. At the request of the College or State Surveillance Authority, the holder of the marketing authorisation shall provide a copy of the pharmacovigilance system master file within seven days.
6 The marketing authorisation holder shall inform the College of the date on which the medicinal product is actually placed on the market.
7 Having regard to Article 123 (2) to (2b) of Directive 2001/83, the holder of the marketing authorization shall without delay inform the College and the competent authorities of the Member States concerned, but in any case two months before the date on which it is to be placed on the market. the suspension of a medicinal product shall be interrupted, and for reasons of reasons, as follows:
a. Suspending the trade of a medicinal product;
b. Taking out a medicinal product from the market;
(c) the application for revocation of a marketing authorisation; or
(d) the non-application of an application for renewal of a marketing authorisation.
8 Without prejudice Article 77, first paragraph, point (d) , the holder of the marketing authorization for a medicinal product on request to the College shall provide information on the volume of sales of the medicinal product and the particulars in its possession concerning the number of prescriptions.
9 The holder of a marketing authorisation shall ensure that the medicinal product to which the marketing authorisation relates is sufficiently advanced for wholesalers or pharmacists to meet the needs of patients.
1 The holder of a marketing authorization shall not make any change to a medicinal product without the prior consent of the College, if that amendment necessates adjustment of the particulars and documents submitted to the application. In the case of a marketing authorisation for a traditional herbal medicinal product, the holder shall also request the College to amend the particulars or documents submitted on the application, subject to the request of the Committee for the purpose of medicinal products containing a new Community herbal monograph which may reasonably be presumed to be necessary for the adaptation of such data or records.
2 The holder of a marketing authorization shall submit any proposed changes to the outer packaging, the immediate packaging, or the text of the package leaflet to the College.
3 The holder of a marketing authorization shall notify the College of a change in the methods of preparation and of an amendment to the non-active substances of a medicinal product, to the extent that such changes may reasonably be made to is not affected by the action of the medicinal product. If the College considers that a change as referred to in the first sentence does affect the operation of a medicinal product, it shall forthwith communicate this to the Commission and shall treat this communication as a request for authorisation of a change as referred to in the first paragraph.
1 The College shall suspend, amend or revoke a marketing authorization if:
a. the medicine is harmful,
therapeutic effect is lacking or if consideration of benefits and risks is not favourable,
(c) the medicinal product does not possess the specified qualitative and quantitative characteristics;
d. the Article 42 presented data and documents are incorrect or not modified in accordance with Article 49 ,
e. the in Article 28, first paragraph , the checks referred to have not been carried out,
f. the labelling or package leaflet does not comply with the labelling Chapter 7 requirements,
g. not subject to requirements under Article 45a or 45b Is satisfied,
h. The Marketing Authorisation Holder: Chapter 8 does not comply with its obligations, or
i. if the coordination group has decided on the basis of Article 107g of Directive 2001/83,
j. if the preparation or quality control by the manufacturer is not in accordance with the requirements set out in the dossier on the basis of which the relevant marketing authorisation has been granted.
2 If active ingredients of a herbal medicinal product as specified in Article 42, eighth paragraph The marketing authorisation for a traditional herbal medicinal product shall be taken from the list drawn up by the Committee on Herbal Medicinal Products, which shall be the subject of a marketing authorisation.
3 The College shall revoke a marketing authorisation upon written request from the holder.
4 In the case of ministerial arrangements, detailed rules may be laid down concerning the granting, amendment, suspension or revocation of a marketing authorisation.
5 The College shall make a decision on suspension or revocation of a marketing authorisation open to the public.
6 In applying this Article, the College shall respect Article 31, third paragraph, of Directive 2001/83.
1 The College may, for reasons of public health, grant a marketing authorisation to a legal person eligible for the grant, who may agree to grant it, if the medicinal product concerned is not in the Netherlands It is, however, in another Member State.
The College shall inform the holder of the marketing authorisation in the other Member State of its intention to grant an authorisation at the foot of the first paragraph.
3 The College may request the competent authority of the other Member State to send a copy of the assessment report and to the marketing authorisation in force in the other Member State. If the College receives a request from another Member State, the College shall, within 30 days of receipt of the request, dispatch the requested documents.
4 The College shall inform the Commission of the granting of a marketing authorisation in accordance with the first paragraph. Such notification shall be accompanied by an indication of the name and address of the legal person to whom the authorisation has been granted. The same shall apply if the College withdraws the marketing authorization concerned.
The College shall keep a public register of medicinal products for which it has been granted a marketing authorisation or a parallel marketing authorisation. This register shall contain at least the indication of the number under which the medicinal product has been registered, the name of the medicinal product and the name of the holder of the authorisation. The College shall register suspensions of a marketing authorization and issue medicinal products whose marketing authorization has been revoked or which has expired automatically, from the register.
1 For the examination of an application for a marketing authorisation or for a parallel marketing authorisation, the applicant shall be entitled to the College for a fee.
2 The holder of a marketing authorization also owes a fee for the consideration of a request for consent to make a change as intended. Article 49, first paragraph , or 50, 1st Member .
3 For the purpose of maintaining the registration of a marketing authorisation or a parallel marketing authorization in the public register, Article 53 , the holder of such authorization shall be liable to the College for each year to pay a fee.
4 Without prejudice Article 10 , the rate of the fees referred to in the first, second and third paragraphs shall be fixed by ministerial arrangement.
1 The Articles 44, third, fourth and fifth members , and 46, third and fourth members , this Act, together with Articles 32, 33 and 34 of Directive 2001/83 do not apply to herbal medicinal products as intended to be included in the Directive. Article 42, eighth paragraph , except as regards the herbal medicinal product in question, a Community herbal monograph referred to in Article 45, sixth paragraph , prepared or active ingredients, on a list as referred to in Article 51, second paragraph -To prevent it.
2 Article 45, second paragraph, points (b) and (c) , does not apply when active ingredients of a herbal medicinal product are considered to be Article 42, eighth paragraph , on the list, intended in Article 51, second paragraph They're placed.
3 The Articles 44, third, fourth and fifth members , 46, third and fourth members , do not apply to homeopathic medicinal products other than those specified in the Article 42, third paragraph .
4 Articles 32, 33 and 34 of Directive 2001/83 shall not apply to homeopathic medicinal products.
5 Article 45, first paragraph, point (b) , does not apply to homeopathic medicinal products as intended in Article 42, third paragraph .
The College shall also decide on the classification of a medicinal product when granting a marketing authorization. A medicinal product shall be classified in one of the following categories:
a. UR medicine;
b. UA medicine;
c. UAD-drug;
AV medicinal product.
1 The College decides on the classification of a medicinal product as an UR-medicinal product if it:
a. In the case of normal use, it may also directly or indirectly pose a risk where it is used without medical supervision,
b. frequently and widely not used in accordance with the requirements of use, as a result of which the health may be directly or indirectly endangered,
c. contains a substance or preparation which, because of its novelty, must be further studied for its efficacy or side effects; or
d. is for parenteral administration.
2 The College may decide that a marketing authorisation for an UR medicinal product is granted under the condition that it:
a. to be used solely for hand or to be administered in a Article 5 of the Law authorising health care institutions institution designated as a general or psychiatric hospital, or
b. may be prescribed solely by a doctor or dentist who is enrolled in a college designated by the College. Article 14 of the Act on appeals in individual health care set up register of medical or dental specialists.
1 The College decides on the classification of a medicinal product as a medicinal product if, in its opinion, it is necessary from the point of view of medication surveillance, information or guidance in the case of the supply.
The College decides on the classification of a medicinal product as an AV medicinal product if it is justified in its opinion from a safe use, having regard to the active substance, the dosage and the packaging size.
3 The College decides on the classification of a medicinal product as an UAD-medicinal product if it is not considered for classification as a UA medicine or as an AV medicine.
4 If a medicinal product is not classified as an UR medicinal product when granting a marketing authorization by the Community, the College shall determine the classification by reference to the first, second and third paragraphs.
5 In the case of ministerial arrangements, detailed rules are laid down for the criteria on which the College decides on the classification of a medicinal product as a medicinal product or as an AV medicinal product. The design of the scheme shall be submitted to the Second Chamber of the States-General at least 4 weeks prior to its adoption.
1 The College shall, in accordance with the criteria set out in the Articles 57 and 58 , again, a decision on the classification of a medicinal product if the College of new information which has been informed has shown that it is necessary to amend the classification.
2 Our Minister may ask the College to reassess the classification of a medicinal product designated by Our Minister.
3 If, at the request of the Marketing Authorisation Holder, the College has changed the classification of a medicinal product based on significant preclinical or clinical trials, the College may, for a period of one year, be date of the new classification decision of the College, do not change the classification of another medicine on the basis of those tests.
4 If, other than at the request of the Marketing Authorisation Holder, the College wishes to change the classification of a drug, the decision to change the classification shall not be taken than after the marketing authorisation holder, within one by the College indicated time limit, the file on the basis of which the marketing authorisation was granted has adapted to the new classification.
The College draws up a list of UR medicines, of UA medicines, of UADs, and of AV medicines. These lists are generally available. The College shall update these lists at least once a year.
1 Without prejudice to the provisions of this Act, any person shall be prohibited from buying or providing for sale UR medicinal products or UA medicines, with the exception of:
a. Pharmacists who exercise their profession in a pharmacy;
b. A doctor who holds a licence as referred to in the tenth or eleventh member;
(c) persons and bodies designated for that purpose by ministerial arrangement in the circumstances referred to in the procedure.
2 It is an individual, except for pharmacists exercising their profession in a pharmacy, and prohibited by a ministerial order, to use medicinal products for investigation.
3 The pharmacist or the pharmacist ' s pharmacies may only carry out the medicine in one pharmacy.
4 In the absence of the pharmacist, he shall provide for observation within the occupational group.
5 However, pharmacists acting in a pharmacy do not have the power to use UR medicinal products only after the person in charge of the pharmacy, at their request, is registered in the case of the pharmacy. Public health control established by established pharmacists. The address of the pharmacy shall be recorded in the register.
6 An entry in the register of established pharmacists shall be refused if the applicant is not registered in the Article 3, 1st paragraph, of the Act on the professions in the individual health care a register of pharmacists or his registration has been suspended in that register. Registration shall also be refused if the pharmacist concerned has already been registered in the register for another pharmacy.
7 The registration in the register of established pharmacists shall expire automatically if the person concerned is no longer registered in the Article 3 of the Act on Professions in Individual Health Care the register of pharmacists. The invitation to tender shall be resold if so requested by the person concerned.
8 To professionals as referred to in Article 1 (ll) and (third) Medicinal products shall be put into service only after receipt of a written request for that purpose. The application shall state the name, address and capacity of the applicant, as well as the name and quantity of the medicinal product.
9 The pharmacist who works in a pharmacy shall be prohibited from taking an UR medicinal product by hand without a prescription being produced. However, it shall be empowered to provide an UR medicinal product in the event of an emergency situation without the presentation of a prescription, if he has provided sufficient assurance that a risk of abuse cannot arise.
10 Our Minister, on request of a general practitioner practic in medical practice in a contiguous area, grants authorisation to prepare and hand UR or UA medicinal products to patients of his practice, if the distance between the most close to that area and the most close to that pharmacy resident in that area is measured at least 4,5 kilometres on the road intended for the use of motorised traffic. If the distance referred to in the first sentence is less than 4,5 kilometres, but more than 3.5 kilometres, our Minister shall authorise the authorisation if this is in the interest of the supply of medicinal products.
11 Our Minister shall grant to the general practitioner who exercises medical practice together with a general practitioner to whom a licence as referred to in the 10th paragraph has been granted, on request, a licence to grant UR or UA medicinal products for the benefit of the prepare the patients he treats, prepare them in the pharmacy of the general practitioner with whom he exercises the practice.
12 A licence as referred to in the 10th paragraph shall expire automatically if the holder of the authorization ends the medical practice or is no longer registered in accordance with Article 3 of the Act on Professions in Individual Health Care the register of doctors established.
13 Our Minister shall revoke a licence as referred to in the 10th paragraph where the grounds for the granting of such authorization have expired.
14 A licence as referred to in paragraph 11 shall be cancelled if the general practitioner with whom the holder of that licence exercises the practice is no longer in possession of a licence as referred to in the 10th paragraph.
15 The costs associated with the examination of the application and the issue of the licences referred to in the 10th and 11th paragraphs may be charged to the applicant for the document. An annual fee may be charged to the holder of a licence. The amounts to be reimbursed for the costs and the amount of the annual fee shall be determined by means of a ministerial arrangement.
1 Without prejudice to what is provided elsewhere in this Act, all persons shall be prohibited from buying or providing for sale UADmedicines, with the exception of:
a. Pharmacists who exercise their profession in a pharmacy;
b. homers as intended in Article 61, first paragraph, point (b) ;
c. the under Article 61, first paragraph, point (c) , designated persons or bodies;
d. Dregists exercising their profession in a drugstore or in any other point of sale of UADs.
2 The person who carries out sales activities in the exercise of a business and, in that context, by the persons referred to in point (d) of the first paragraph, has to provide UADs with medicines for the hand, should provide responsible care. In any case, the provision of responsible care shall mean that:
a. The terhand shall be carried out under the responsibility and under the supervision of a drugstore;
(b) The person to whom an UAD medicinal product is placed is informed in a clear manner of what he should reasonably know about the nature and purpose of the medicinal product and its likely consequences and risks for his/her own health, unless it has indicated that there is no need to have it;
c. may only provide a drugstore or an assistant drugstore with the information referred to in subparagraph (b); and
d. In the point of sale, there are sufficient droists and droists who can provide this information to customers.
3 Without prejudice to the provisions of this Act, any person shall be prohibited from buying or providing for sale AV medicinal products, with the exception of the persons or bodies referred to in points (a), (b), (c) and (d) of the first paragraph, and exception of those who carry out sales activities in the exercise of a business and are registered for that purpose in the Commercial Register, referred to in Article 2 of the Commercial Registry Act 2007 .
The Articles 61 and 62 shall not apply to doctors and pharmacists who are employed by the Ministry of Defence in that capacity.
It is doctors and pharmacists as intended Article 63 -prohibit the use of medicinal products to persons outside the armed forces unless it is manifestly necessary for the performance of tasks entrusted to the armed forces.
In the case of a general measure of administration, rules may be laid down for the supply of medicinal products within the armed forces. If this is manifestly necessary for the operational deployment of the armed forces or their preparation, it may be derogated from by this Law.
1 In the case of, or under general management, detailed rules may be laid down regarding the preparation and the use of medicinal products in pharmacy.
2 The pharmacists and pharmacists shall ensure that prescriptions, medicinal products, preparations for the preparation of medicinal products and substances referred to in List I or List II of the veterinary medicinal product are given in Opium Law Non-medicinal products shall be kept in accordance with rules to be laid down by ministerial rules.
1 The pharmacist may, if the patient has given his consent to the patient, seek to obtain the care required by him for the purpose of providing the patient with the marketing of a medicinal product, consult and retain. The pharmacist asks the laboratory results for the person who is responsible for the results and the person who provides them.
2 In the case of ministerial arrangements, rules shall be laid down:
a. the laboratory data necessary for the use of medicinal products, which may vary for different categories of medicinal products; and
The method of transmission of the laboratory data to the pharmacist.
It is prohibited to prescribe drugs to any person who has never met the prescriber personally, or who does not know the prescriber or whose prescriber the medical history has not been available.
1 Without prejudice to the provisions of Articles 61 , 62 and 67 , it is prohibited to offer or put to hand sale of medicinal products remotely other than according to the rules to be laid down by Ministerial Regulations for the implementation of Directive 2001/83.
2 Further rules may be laid down for the purpose of providing for the sale or use of medicinal products for the purpose of protecting public health, or on the basis of a general rule of management.
1 Our Minister is responsible for a national website on the distance marketing of medicines. A ministerial arrangement lays down rules for the implementation of Directive 2001/83 on the provision of information through this website.
2 In collaboration with the Commission and the Office, our Minister organises or promotes information campaigns on the dangers of falsified medicines.
1 The prescription of medicinal products outside the board of the College is permitted only if they have been developed within the occupational group of protocols or standards within the framework of the professional group. If the protocols and standards are still under development, consultations between the treating physician and pharmacist are necessary.
2 In cases to be determined by ministerial order, the prescription shall state the reason for the prescription.
1 The manufacturer shall ensure the labelling of a medicinal product, other than an investigational medicinal product, or for advanced therapy, or a medicinal product prepared in a pharmacy, including the affixing of safety features to the medicinal product. provided for in Article 54 (o) of Directive 2001/83, in compliance with the rules to be laid down by ministerial rules.
2 The manufacturer is also responsible for the presence of a package leaflet in the package of a medicinal product, other than a medicine used to study or for advanced therapy, or to a medicinal product prepared in a pharmacy, taking into account of the rules to be laid down by ministerial arrangements.
3 In the case of, or under general management, rules shall be laid down for the labelling of medicinal products for examination or for medicinal products prepared in a pharmacy.
4 The College may exempt from or pursuant to this Chapter the rules to be laid down by Ministerial Regulations.
The State Supervision of Public Health shall inform the Commission of non-prescription-only medicinal products at risk of falsification and may inform the Commission of any medicinal products covered by the criteria set out in Article 54a, Second paragraph, part b of Directive 2001/83, it may be considered that there is no risk of distortion.
This Chapter shall not apply to medicinal products which:
a. have been repackaged by a doctor who is employed by the Ministry of Defence in that capacity; or
b. To be put into service by trained military personnel, provided that they are carried out under operational conditions, or in the course of the preparation of the military personnel.
1 The College is responsible for pharmacovigilance. The College shall apply a pharmacovigilance system to carry out its tasks in this field and to participate in the pharmacovigilance activities of the European Union.
2 The rules on pharmacovigilance tasks and powers of the College shall be subject to a ministerial arrangement.
3 Our Minister promotes the creation of and cooperation between institutions of professionals and patient organisations in health care whose purpose is to provide data on adverse reactions and the use and misuse of medicines for which a the marketing authorisation has been granted to collect, register and analyse, and other organisations operate in this field.
1 The holder of the marketing authorisation shall contribute to the monitoring of medicinal products subject to the marketing authorisation by applying a pharmacovigilance system consistent with the pharmacovigilance system provided for in this Directive, which is intended to be used in the marketing authorisation procedure. Article 76, first paragraph .
2 In the case of a ministerial arrangement, detailed rules on the pharmacovigilance tasks of the holder of the marketing authorisation shall be laid down.
1 The College shall ensure a national web portal for medicinal products that corresponds to the European medicines web-portal.
2 Under ministerial arrangements, rules are laid down on public transfers by the College through the national medicines web-portal.
The holder of the Marketing Authorisation and the College shall each separately provide public communications based on pharmacovigilance data on risk in the use of medicinal products. These public communications shall be subject to ministerial rules.
1 The marketing authorisation holder shall record all suspected adverse reactions occurring within the European Union or in third countries and notified to it, regardless of the reporting system or study after admission to which they are issued. The registration and notification of suspected adverse reactions by the Marketing Authorisation Holder shall be subject to detailed rules under ministerial arrangements.
2 The College records all suspected adverse reactions occurring in Dutch territory which are reported to him by professionals and patients, and makes reference to the rules to be laid down by ministerial rules.
3 Professional professionals report immediately any suspected serious adverse reaction to an organ of professionals and patient organisations as referred to in Article 76, third paragraph , as well as any suspected transfer through a medicinal product from infectious agents.
4 The body referred to in paragraph 3 shall ensure that all the reported signals are accessible to all, with due regard to the rules applicable to the protection of privacy. The institution shall forward to the College an overview of all the signs of adverse reactions at least every three months.
1 The Marketing Authorisation Holder shall submit electronic periodic safety update reports to the Agency.
2 In the case of ministerial arrangements, detailed rules on the content, transmission and transmission frequency of periodic safety update reports shall be laid down.
1 The College assesses periodic safety reports in order to identify new or changed risks or changes in the balance of benefits and risks of medicinal products.
2 On the basis of the assessment referred to in paragraph 1, the College shall, if necessary, take measures concerning the marketing authorisation of the medicinal product concerned.
In the event of any of the following cases, Articles 107i to 107k of Directive 2001/83 shall apply:
a. Where a marketing authorisation is envisaged to be suspended or withdrawn;
(b) when considering the prohibition of the provision of a medicinal product;
(c) where it is envisaged to refuse renewal of a marketing authorisation;
If the holder of the marketing authorization has notified the interruption of the marketing of a medicinal product, or has taken measures to withdraw a marketing authorization, at least it intends to take such measures; a marketing authorisation has not been applied for, due to risks relating to the safety of a medicinal product, or to an application for renewal of a marketing authorisation;
e. when a new contraindication, a reduction in the recommended dosage or a restriction of the indications is considered necessary.
Non-interventional safety studies after admission are not performed when the conduct of the study would promote the use of a drug.
2 For their participation in non-interventional safety post-authorisation safety studies, professionals only receive compensation for the time spent and costs incurred.
3 Our Minister charged one or more bodies with the assessment of draft protocols of non-interventional safety studies after admission as referred to in Article 107quani of Directive 2001/83 taking place exclusively in the Netherlands. In the performance of its tasks, the notified body shall comply with the provisions of Article 107quini to 107q of Directive 2001/83.
4 The implementation of non-interventional safety studies after authorisation and the duties and powers of the Marketing Authorisation Holder and of the College shall be subject to detailed rules.
This chapter does not apply to homeopathic medicinal products as referred to in Article 42, third paragraph -From this law.
In the framework of work on signal detection with regard to this chapter, the College and the Marketing Authorisation Holder shall respect the provisions of Article 107h, first and third paragraphs, of Directive 2001/83.
1 The College may delegate to the maximum of one competent authority of another Member State its pharmacovigilance tasks under this Chapter or the pharmacovigilance tasks of up to one competent authority of another Member State in writing, provided that the competent authority agrees in writing.
2 If delegation as referred to in the first paragraph takes place, the College shall inform in writing the State Public Health, the Commission, the Agency and all the other Member States in writing. The College shall also make this information accessible to the public.
1 In this chapter, the following definitions shall apply:
a. Professional person: a doctor, pharmacist, dentist, obstetrician, nurse as intended Article 36, fourteenth member, point (d) of the Act on Occupation in Individual Health Care , pharmacist's assistant or a natural person or a legal person as referred to in Article 62, first paragraph, point (d) and (3) ;
b. entrepreneur: the holder of a marketing authorisation or of a marketing authorisation as referred to in Article 18, first paragraph, second sentence .
2 For the purposes of applying Article 94 (b) In so far as a meeting is concerned, a professional practitioner shall also mean a nurse who, in the exercise of his profession, is assigned or provided to patients by a doctor, dentist or midwifery medicinal product.
This Chapter shall not apply to:
a. investigational medicinal products, other than those for which a marketing authorisation has been granted and which are used as a comparison material in a medical-scientific study with humans;
b. the package leaflet and the labelling of a medicinal product;
c. a letter or an email notice in order to request information on a medicinal product;
d. information on health or disease in humans.
1 Advertising for, or award of, a medicinal product for which no marketing authorisation has been granted shall be prohibited.
2 Data other than those referred to in Article 73, second paragraph, points (a) to (l) , are not to be advertised for homeopathic medicinal products as intended in Article 42, third paragraph I'm using it. All aspects of advertising for medicinal products other than those referred to in the first sentence shall be in accordance with the information contained in the summary of the product characteristics of the medicinal product concerned.
3 Advertising that does not promote the rational use of a medicinal product due to the lack of an objective representation of the product shall be prohibited.
4 Misleading advertising is prohibited.
Advertising to the general public shall be prohibited for medicinal products which:
a. may only be made available on prescription;
b. may be placed in service without a prescription and containing means of a kind used in accordance with list I or Opium law II .
1 Public advertising shall meet the following requirements:
a. The advertising is displayed in such a way that the message is sent to the public and to the public quite clearly that it is a medicinal product;
b. the advertising shall contain the name and the common name if the medicinal product contains only one active substance;
c. The advertising contains information that is essential for the proper use of the medicinal product;
d. The advertising includes the express request to read the Package Leaflet or the text on the outer carton.
2 The first paragraph (c) and (d) shall not apply where advertising is intended solely for the purpose of recalling the name of the medicinal product to the public.
Advertising of a herbal medicinal product as intended Article 42, eighth paragraph The indication is that it is a traditional herbal medicinal product, in which indications it is used and that the indications are based solely on long-standing use.
Advertising of the general public shall be prohibited if it is stated or by its formulations or images that it may indicate that:
a. The use of the medicinal product makes a medical examination or surgery unnecessary;
(b) the medicinal product does not have any side effects or that the effect is superior to or equal to the functioning of another medicinal product or any other medical treatment;
c. the normal good health of a person by the use of the medicinal product may be improved;
d. the normal good health of a person may be affected if the medicine is not used;
(e) the safety or efficacy of the medicinal product is due to the fact that it is a natural substance.
The advertising of the general public shall also be prohibited if:
a. This is intended solely or primarily for children;
b. This is a commendation or a reference to a commendation of scientific practitioners, professionals or persons known to the public;
c. in which the medicinal product is equated with a foodstuff, a cosmetic product or other goods;
d. may result in incorrect self-diagnosis by the description or the detailed depiction of a disease history;
e. it makes a misleading reference to a statement of genealquestions;
f. it is made in a frightening or misleading way that images of changes of the human body as a result of an illness or injury or of the action of the medicinal product in the human body are used;
(g) indicating that the medicinal product has a right to claim under the statutory social health insurance schemes.
The prohibitions referred to in the Articles 85 , 88, point (d) , and 89 (g) , do not apply to general advertising for the promotion of participation in the vaccination programme, Article 4a, first paragraph, of the Public Health Act .
1 Without prejudice Article 84 , indicate advertisements aimed at professional persons:
a. the composition, therapeutic indications, contra-indications, functioning and adverse reactions of the medicinal product corresponding to the summary of the characteristics of the medicinal product;
(b) the classification of the medicinal product with regard to the terhand setting.
2 Documents recorded in documents handed over to or sent to professionals shall indicate, in addition to the information referred to in paragraph 1, the following:
(a) or to the provision of the medicinal product, which is a claim under the statutory social health insurance scheme;
(b) the date on which the documents were drawn up or last amended.
3 The information contained in the documents referred to in paragraph 2 shall be such that it is accurate, up to date, verifiable and in full that the practitioner may consider the therapeutic value of the medicinal product.
4 quotations or tables or other illustrations drawn from scientific publications or medical journals are presented in documents as referred to in the second paragraph and are presented exactly with accurate source words.
5 The first to fourth paragraphs shall not apply where advertising is intended solely for the purpose of recalling the name of the medicinal product in the case of professionals.
1 It shall be prohibited to provide samples of a medicinal product free of charge, unless:
a. For that purpose, a duly dated and personally signed application by a professional person empowered to prescribe UR medicinal products has been submitted to the economic operator concerned;
(b) the sample size does not exceed the smallest packaging in the market;
c. to be provided to a professional person referred to in point (a) not more than 2 samples of the same medicinal product in each calendar year,
(d) the sample indicates that it is free of charge and must not be sold,
e. a copy of the summary of the characteristics of the medicinal product has been added to the sample; and
f. The person providing the sample free of charge, keeps records of who, by which date and in what quantity it has been provided.
2 It shall be prohibited to provide to a professional person any samples containing means as intended for the purpose of list I or Opium law II .
The economic operator shall ensure that the person who, on behalf of or on behalf of him, visits doctors, pharmacists, dentists or midwives in order to advertise and provide information on a medicinal product:
a. having a good consequence of training to a visitor to a visitor that he has sufficient scientific knowledge to give details of the medicinal products for which it is advertising, and to give as complete information as possible;
(b) on each visit to a doctor, pharmacist, dentist or obstetrician, give the summary of the characteristics of the medicinal product to the person concerned or to the person concerned;
c. at the Article 95 the scientific service referred to him by a doctor, pharmacist, dentist or midwife, reports on unwanted side effects of medicinal products for which he is advertising, and on all other aspects related to the use of the medicinal product concerned. the use or operation of those medicinal products.
Award of award shall be prohibited unless:
a. Against the funds offered, offered or awarded to a professional practitioner or on money valuable services or goods or in the form of funds, services or goods accepted or received by a professional practitioner; on the basis of a written agreement, a performance is carried out by the professional practitioner in a reasonable proportion of the goods, services or goods and of interest in the exercise of medicine, pharmacy, the dental or obstarts,
b. a meeting or manifestation in which the hospitality offered is limited to what is strictly necessary to participate in the meeting or the event,
c. the money or money-valued services or goods, other than a meeting or manifestation, in respect of which there is no performance of the professional person, which have a low value and are relevant to the exercise of the medicine, pharmacy, dental or obstarts; or
d. It is a question of discounts and bonuses relating to the procurement of medicinal products by persons and legal persons as referred to in Article 4 (2). Article 62, first paragraph, points a, b and d .
1 The holder of the marketing authorization shall have a scientific service responsible for providing information on the medicinal products which he places on the market.
2 The economic operator shall keep a copy of any advertising message which has been sent to him, including the category of persons, including legal persons, to whom the advertising has been directed, of the way in which the advertising is distributed and of the advertising the date of first distribution, at the disposal of the public health officials responsible for monitoring compliance with this Law, or shall transmit it, if requested.
The transmission of teleshopper shopping is prohibited.
1 Our Minister shall ensure that a request from the Office or an authority in another Member State is responsible for the granting of licences as referred to in Article 4 (1) of the Treaty. Article 18, first paragraph , in order to provide information about the compliance with legal obligations or the conditions attached to a permit that apply to a manufacturer or a wholesaler, is given as soon as possible. The same shall apply to a request from the Office or from such a body for information relating to a certificate as referred to in Article 100b, first to third paragraphs .
2 The College shall ensure that a request from the Office or an authority in another Member State is responsible for issuing marketing authorisations for medicinal products for the purpose of providing information on compliance with the requirements of this Directive. the legal obligations or the conditions attached to a marketing authorization which are applicable to the holder of a marketing authorisation shall be taken as soon as possible.
3 A certificate issued in another Member State pursuant to a provision which corresponds to a material equivalent to Article 100b, first to third paragraphs , has the same legal effect as a certificate issued in the Netherlands under the relevant provision.
4 A report drawn up in another Member State pursuant to a provision which corresponds to equipment Article 100a, first paragraph , has the same legal effect as a report drawn up in the Netherlands under that provision.
5 If, for reasons relating to public health, our Minister considers that a certificate issued in another Member State as referred to in paragraph 3, or a report drawn up in another Member State, as referred to in the fourth paragraph, the Netherlands should not have the same legal effects as the legal effects of the other Member State, it shall immediately inform the Commission, the Agency and the Member State concerned accordingly.
6 If another Member State considers that a certificate issued in the Netherlands as referred to in paragraph 3, or a report drawn up in the Netherlands, as referred to in Article 100a, first paragraph , if the legal consequences thereof in the Netherlands and the Commission of the inspector who carried out the inspection are requested to carry out a new inspection, this request shall be taken as a result.
1 Our Minister shall ensure that action is taken on a request made by a public authority of a third country, a manufacturer or a wholesaler who carries out medicinal products, to permit the authorisation of medicinal products for medicinal products from a third country. to certify a manufacturer. Certification shall be carried out in accordance with the relevant administrative rules of the World Health Organisation and shall be accompanied by a copy of the relevant certificates issued in accordance with Article 46, first paragraph , approved summary of the characteristics of the medicinal product.
2 If the manufacturer does not have a marketing authorization, he shall, if requested by the first member of the marketing authorisation, make a statement to our Minister, if requested, for a statement explaining the reason for the marketing authorization.
3 The costs associated with the examination of the application by the manufacturer or wholesaler and the issue of the certificate provided for in paragraph 1 may be charged to the applicant for the document. The amounts to be reimbursed for the costs shall be determined by ministerial arrangements.
1 At the request of the Commission, the Agency, the College, the supervisory authority of another Member State, or the body competent to grant marketing authorisations in another Member State, the State Supervision of Public Health may carry out inspection with a manufacturer, a wholesaler, a manufacturer or wholesaler of active substances, or a manufacturer or importer of excipients.
2 A manufacturer may request the State Supervision of Public Health to carry out an inspection at manufacturers or wholesalers of active substances or excipients.
1 With the monitoring of compliance with or pursuant to this Act, officials of the State Supervision shall be responsible for the public health determined by the decision of Our Minister. Notice of such decision shall be taken by the State Official Gazette.
2 By way of derogation from the first paragraph, the supervision of compliance with this law on board ships intended for use in commercial shipping or sea fishing shall be the responsibility of the decision of our Minister for Infrastructure and Environment designated officials of the Environment and Transport Inspectorate.
3 By way of derogation from the first paragraph, our Minister of Defence shall be in charge of the supervision of compliance with this Act as far as it relates to its execution within the Dutch armed forces.
4 For the purposes of this Chapter, our Minister shall also mean our Minister of Infrastructure and the Environment or our Minister of Defence to the extent that the supervision of compliance with this Law takes place on the basis of the second Member of the third party.
5 The officials referred to in paragraphs 1 and 2, and officials assigned by or on behalf of our Minister of Defence for the task referred to in the third paragraph:
(a) ensure that inspections are carried out in accordance with rules to be laid down by Ministerial Regulations; and
b. do not have any interest, financial or otherwise, in the pharmaceutical industry that can bring conflicts of interest with them. They shall make a statement on their financial interests to the Minister for whom it is responsible.
If an inspection is carried out in connection with the supervision of compliance with this Act, a report shall be drawn up. The State surveillance of public health shall ensure that the content of the report is communicated to the person carrying out the inspection, and shall be given the opportunity to comment before the report is taken. 3.
2 If during an inspection it is found that the holder of the marketing authorisation does not comply with the pharmacovigilance system as described in the pharmacovigilance system in question or other obligations on the system of pharmacovigilance, or land of Chapter 8 of this Act, the State Supervision of Public Health shall designate him thereon and shall give him the opportunity to comment. The State Supervision of Public Health shall inform the College, the other Member States, the Agency and the Commission thereof.
3 If an inspection points out that there is non-compliance with regulations as referred to in Articles 27, 1st or 2nd Member , 36, 1st Member , respectively 38b, 1st Member , the State Supervision of Public Health reported on this in the EudraGMP-database, to Our Minister and to the College.
4 They work together in the field of coordination of inspections in third countries. On a reasoned request, the State Government shall report on public health, as referred to in the first paragraph, to another Member State or to the Agency electronically.
1 Where a report as referred to in Article 100a, first paragraph , to this end, the person in receipt of an inspection of the compliance with the requirements of the Regulation shall receive Articles 27, 1st or 2nd Member , 36, 1st Member , respectively 38b, 1st Member , within 90 days of the inspection, a certificate in which the relevant compliance was recorded.
2 If the person concerned is established in a third country and rules equivalent to those laid down in paragraph 1, the certificate shall also be expressed in the certificate.
3 If an inspection has been carried out under the Convention under the Convention, Article 1 (f) (f) , established procedure for obtaining a certificate of conformity to the European Pharmacopoeia monographs, shall provide the State public health surveillance certificate to the person who requested the inspection. A copy of the certificate shall be issued to the person on whom the inspection was carried out.
4 The State Supervision of Public Health shall ensure that a copy of a certificate referred to in paragraphs 1 to 3 is sent to the Office with the request to include it in the EudraGMP-database.
5 The costs associated with the issue of a certificate as referred to in paragraph 1 may be charged to the applicant for the document. The amounts to be reimbursed for the costs shall be determined by ministerial arrangements.
The State Supervision on Public Health, the College and the Agency shall inform each other of planned and implemented inspections. They shall cooperate in the coordination of inspections in third countries.
1 Our Minister may impose an administrative fine of up to € 450,000 in respect of an infringement of the provisions of, or under Article 18 , 26 , 27 , 27a , 28 , 29 , 30 , 31 , 32 , 33 , 34 , 35 , 36 , 37 , 38, 1st Member , 38a, 2nd and 4th Member , 38b, 1st and 2nd Member , 38c , 39, 1st Member , 39a, 1st Member , 40 , 48 , 49 , 50 , 61 , 62 , 64 , 65 , 66 , 66a , 67 , 67a, 1st Member , 69, first and second members , 76a, first member , 77a , 78, first and third members , 78a, first member , 80, first and second members , 84 , 85 , 86 , 87 , 88 , 89 , 91 , 92 , 93 , 94 , 95 , 96 or 122a .
2 Conduct as referred to in the first paragraph which is not an economic offence within the meaning of the Law on economic crimes , is a criminal offence if, in the preceding 24 months, it has been charged twice as an administrative fine on the same conduct.
3 With custody not exceeding six months or a fine of the third category, the person who commits an offence referred to in the second paragraph shall be punished.
4 An offence referred to in the second paragraph shall be an infringement.
Public health officials are responsible for the imposition of a charge under administrative constraints in order to maintain an order as referred to in Article 3 (1) of the EC Treaty. Article 115 , and the Article 5:20, 1st paragraph, of the General Law governing the administrative law obligation.
1
In order to prevent any damage to public health, the officials of the State Supervision shall be empowered to give an order:
(a) suspend or terminate the preparation, delivery, trade, import, export or sale of a medicinal product, or a substance which is apparently intended for the preparation of medicinal products;
(b) allow a medicinal product or substance to be removed from the market of a substance which is apparently intended for the preparation of medicinal products;
c. to close a pharmacy if, in their opinion, the pharmacy does not have the necessary guarantees for the safe preparation, storage or sale of medicinal products.
The State surveillance of public health shall ensure that a decision on the marketing or prohibition of the delivery of a medicinal product is notified to the Office forthwith. If such a decision is likely to affect public health in a third country, the World Health Organization shall be informed thereof.
3 In applying this Article, the State Supervision of Public Health shall respect Article 31 (3) of Directive 2001/83.
1 Public health officials, persons, persons, designated at or under the control of the State Article 141 of the Code of Criminal Procedure and the officials of the tax authority responsible for customs administration are responsible for the investigation of the offences referred to in the Article 101 .
2 The officials referred to in paragraph 1 shall be seized at any time and shall be seized upon seizure of the extradition of the substances and articles which may serve the purpose of discovery of the truth or of which the persons concerned may have the right to surrender their goods. Confiscation, withdrawal of traffic, destruction or deactivation may be ordered.
1 The authorisations granted under the law prior to the entry into force of this Act Act on the Supply of Medicinal Products have been granted for the preparation and delivery of medicinal products, shall be treated as permits for the preparation and delivery of such equipment for the purposes of this Law.
2 The authorisations granted before the entry into force of this Act Act on the Supply of Medicinal Products have been granted only for the supply of medicinal products after importation, shall be treated in the same way as authorisations for the introduction of such funds for the purposes of this Law.
3 The licences issued prior to the entry into force of this Act Act on the Supply of Medicinal Products have been granted for the exclusive delivery of medicinal products other than after importation, for the purposes of this Law shall be treated as licences for the conduct of a wholesale trade.
4 Tenders in a register as referred to in Article 3 of the Act on the Provision of Medicinal Products which have been either made before the entry into force of this Act or the authorisations granted under that Act for the packaging, labelling and delivery of medicinal products concerned from another Member State for the purposes of this Act Trade licences shall be treated in the same way as parallel trade licences.
5 The tenders in a register referred to in Article 3 of the Act on the Provision of Medicinal Products for the purposes of this Law, applications for registration which have been submitted before the date of entry into force of this Law and which have not yet been decided shall be treated as In the case of marketing authorisations, commercial licences shall be subject to a marketing authorisation. However, the equalization provided for in the first sentence shall not apply to the application of the provisions of Article 42, fifth paragraph, point (a) , and 43, second paragraph Those periods referring to reference medicinal products for which registration or application for registration as referred to in the first sentence was made before the entry into force of this Law has been submitted and not yet submitted to it. Irrevocable is decided. For tenders submitted in the register referred to in the first sentence, which were effected before 30 October 2005, and the applications for registration lodged before that date, the period of protection shall continue to be covered by the period of protection of the Member States. Article 2, eighth paragraph, introductory wording and point (a) of the Decision on registration of medicinal products provided that it was applicable before the entry into force of this Act, without prejudice to the law relating to the protection of industrial and commercial property.
6 [ Red: Expated.]
7 The medicinal products referred to in Annexes VII, IX, XI, XII and XIII to the Act of Accession which have been subject to a marketing authorization in Cyprus, Lithuania, Malta, Poland and Slovenia are not eligible for treatment by the following: College under the procedure, referred to in Article 44, third paragraph , until such medicinal products have been brought into conformity with the provisions of this Law on the quality, safety and efficacy of medicinal products, but not later than 31 December 2005, 1 January 2007, 31 December 2006, 31 December 2006, December 2008 and 31 December 2007.
8 Applications for authorisation to prepare and deliver or deliver the exclusive supply of medicinal products which have been submitted before the entry into force of this Act and to which is not yet irrevocably decided shall be applied for the purposes of this Act. Equivalent to applications for licences referred to in Article 18, first paragraph, second and third sentences .
9 Licences granted prior to the entry into force of this Act Act on the Supply of Medicinal Products have been granted for the preparation or introduction of investigational medicinal products, for the purposes of this Law shall be treated as permits for the preparation or introduction of investigational medicinal products. Applications for authorisation for the preparation or introduction of investigational medicinal products submitted before the entry into force of this Act and on which decisions have not yet been taken shall be treated as such for the purposes of this Law: applications pursuant to this Act.
10 A recognition of a laboratory which, prior to the date of entry into force of this Act, Article 5, fourth paragraph, of the Decision preparation and delivery of pharmaceutical products is granted, shall be treated as a designation as intended for the purposes of this Law; Article 26, third paragraph .
1 [ Red: Expated.]
2 [ Red: Expated.]
3 In respect of products which comply with the College's opinion, Article 42, eighth paragraph , the application for a marketing authorisation for a traditional herbal medicinal product shall be submitted within one year and eight months after the entry into force of this Act, on submission of the relevant under Article 42, second paragraph , designated data and documents.
4 At the request of the applicant, the College may, up to four years and eight months after the entry into force of this Act, defer the submission of the particulars and documents referred to in paragraph 3.
The doctor who immediately prior to the entry into force of this Act Article 6 of the Act on the Provision of Medicinal Products has the power to exercise the medical authority in a pharmacy which is exclusive to him, it is empowered to provide medicinal products to the patients of his practice. If the power referred to in the first sentence is obtained by a licence, the licence shall be deemed to be equivalent to the licences referred to in Article 61, 10th of the 11th paragraph of Article 61 .
1 [ Red: Expated.]
2 [ Red: Expated.]
3 A change to:
a. Directive 85 /374/EEC the Council of 25 July 1985 on the approximation of the laws, regulations and administrative provisions of the Member States concerning liability for defective products (PbEG L 210),
b. Directive 87 /22/EEC of the Council of the European Communities of 22 December 1986 on the approximation of national measures relating to the placing on the market of hightechnology medicinal products (PbEG L), in particular those derived from biotechnology 15); or
c. Directive 2001/83 ,
shall apply for the purposes of this Act from the date of implementation of the amending Directive concerned.
1 The following Article 6, fourth, fifth, sixth or seventh paragraph, of the Act on the Supply of Medicinal Products Decisions taken after the repeal of that law retain their legal force.
2 The matters pending at the time of that revocation become at the foot of the Article 6 of the Act on Medicines certain handled.
1 For trading licences issued before July 21, 2012, the marketing authorisation holder is required to apply, imposed on and under Article 76a, second paragraph , from this Act to maintain a pharmacovigilance system master file and to make it available on request, from the date on which those marketing authorisations are renewed, but not later than 21 July 2015.
2 Article 80 of this Act shall apply only to post-authorisation safety studies which have been established after 21 July 2012.
3 The obligation of the holder of the marketing authorisation to and under Article 78 This law to report suspected adverse reactions to the Eudravigilance database shall apply from six months after the function specifications of the Eudravigilance database have been established and have been published by the Agency.
4 Until the Agency has taken care to ensure that the Eudravigilance database complies with the function specifications referred to in the third paragraph:
a. The holder of the marketing authorization shall notify the competent authority of the Member State in which they have taken place within 15 days of the presence of serious adverse reactions occurring within the European Union. occurred. In the case of a third country, the holder of the marketing authorization shall also report to the Agency and, on request, to the competent authorities of the Member States in which the medicinal product is authorised;
(b) may require the holder of the marketing authorization to notify him of any suspected adverse reactions occurring within the territory of the Netherlands, no later than 90 days after the date of introduction of the licence;
(c) the College shall ensure that reports of suspected serious adverse reactions concerning the territory of the Netherlands are communicated to the Eudravigilance database without delay, but at the latest within 15 days of becoming aware of the information.
5 The obligation on the holder of the marketing authorisation to be at or under Article 78a Periodic safety update reports shall be communicated to the Agency from 12 months after the establishment of the central register of periodic safety update reports and shall be known by the Agency. Made.
6 Until the Agency has taken care that the register of periodic safety update reports complies with the agreed function specifications, the Marketing Authorisation Holder shall send periodic safety update reports to the Member States in which it is medicine is allowed.
For the purposes of implementing regulations or directives adopted pursuant to the Treaty establishing the European Community, the Agreement on the European Economic Area or the Treaty establishing the Benelux Economic Union relating to the subjects covered by this Act, rules may be imposed by a general measure of administration.
The Act on the Supply of Medicinal Products shall be withdrawn.
This Act shall enter into force on a date to be determined by Royal Decree, which may be adopted in a different way for the various articles and parts of the Member State.
This law is cited as: Medicinal product law.
Burdens and orders that it will be placed in the Official Gazette, and that all ministries, authorities, colleges and officials who so concern will keep their hands on the precise execution.
Given at The Hague, 8 February 2007
Beatrix
The Minister for Health, Welfare and Sport,
J. F. Hoogervorst
Issued the 20th of March 2007The Minister of Justice,
E. M. H. Hirsch Ballin
