Name of law Law amending and supplementing the law on medicinal products for human use the Name Bill a bill amending and supplementing the law on medicinal products for human use acceptance date 26/01/2011 number/year Official Gazette 12/2011 DECREE No 16
On the grounds of art. 98, paragraph 4 of the Constitution of the Republic of Bulgaria
I DECLARE:
To be published in the Official Gazette the law amending and supplementing the law on medicinal products for human use, adopted by the National Assembly of the HLI 26 January 2011.
Issued in Sofia on 3 February 2011.
The President of the Republic: Georgi Parvanov
Stamped with the State seal.
Minister of Justice: Margarita Popova
LAW
amending and supplementing the law on medicinal products for human use (official SG. 31 of 2007; amend., SG. 19 of 2008; Decision of the Constitutional Court No. 5 of 2008-65/2008; amend., no. 71 of 2008, no. 10, 23, 41, 88 and 102 of 2009 and no. 59 and 98 of 2010.)
§ 1. In art. 22, para. 2 make the following amendments and additions:
1. In the text before paragraph 1, after the words "art. 14, para. 3 "is added" art. 114, para. 4 "and a comma and the words" art. 262, para. 6 ' shall be replaced by "art. 262, para. 7. "
2. In paragraph 5, the words "para. 6 ' shall be replaced by "para. 7. "
§ 2. In art. created 28 para. 8:
"(8) where the medicinal product has been granted authorisation for use initially in accordance with art. 23, of any change in the quantity of the active substance in the formulation, in the quantity in the package, in the path of implementation of the medicinal product, and any other change or extension of the authorization for use shall also be granted in accordance with the requirements of this Act or the initial authorisation for use is completed. All these permissions are considered as belonging to a global authorisation for the use of the medicinal product for the purposes of the application of this article. "
§ 3. In art. 54, para. 1 the words "on which the medicinal product will be placed on the market ' shall be replaced by ' of the actual marketing of the medicinal product in the Republic of Bulgaria".
§ 4. In art. 60 is made the following changes and additions:
1. In paragraph 8. 1 the word "immediately" is deleted.
2. Paragraphs 2, 3 and 4 are hereby amended:
(2) changes can be of type IA, type IB, type II, an extension of the marketing authorisation and urgent safety measures.
(3) the conditions and criteria for the classification of the change shall be determined by the Ordinance under art. 42.
(4) a change that is not expanding the scope and classification remains uncertain after the application of the conditions and criteria laid down in the Ordinance under art. 42, is considered a variation of type IB default. "
3. a para. 5:
"(5) by way of derogation from para. 4 change which extension of the scope and classification remains uncertain after the application of the conditions and criteria of the Ordinance under art. 42, is considered a variation of type II in the following cases:
1. at the request of the holder of the marketing authorisation, reflected in the application for a change;
2. when the FDA after an assessment of the validity of the notification according to art. 63 considers that the change may have a significant impact on the quality, safety or efficacy of the medicinal product. "
§ 5. Article 61 shall be replaced by the following: "art. 61. (1) For each change of type IA, type IB, type II or an extension the holder of the marketing authorisation for the medicinal product submitted to the FDA, respectively separate notification application.
(2) where a variation leads to a change in the data of the summary of product characteristics, packaging and/or in the package insert, these changes shall be considered as part of the requested changes and for them not to submit a separate application.
(3) the holder of the marketing authorisation may group the changes when:
1. shall notify it simultaneously to the same changes type IA in the conditions of one or more permissions for use;
2. States several changes in the conditions of use permits belonging to the global permission for use under art. 28, para. 8 of the medicinal product, provided that the relevant changes fall within one of the following cases:
one of the changes) is an extension of the marketing authorisation;
(b)) one of the variations in the group is changing type II, and all other variations in the group are changes that are a consequence of the change type II;
in) one of the changes in the Group's changes type IB and all other variations in the group are changes that are a consequence of the change type IB;
d) all variations in the Group relate only to changes of an administrative nature in the summary of product characteristics, package leaflet for the patient or the packaging;
e) all variations in the group are changes in the basic documentation of the active substance master file or the plasma master file;
is) all variations in the group are in connection with the project, intended to improve the production process and the quality of the medicinal product or his/its active/active substance/substances;
(g)) all variations in the group are changes that affect the quality of a pandemic flu vaccine;
h) all variations in the group are changes in the system of drug safety under Chapter eight;
and) all variations in the group are consequential to a specific emergency measure for safety and are filed in accordance with art. 66;
k) all variations in the Group relate to the inclusion of information about a pharmaco-therapeutic class;
l) all variations in the group are the result of the assessment of periodic safety report;
m) all variations in the group are consequential to a study after obtaining permission for use, conducted under the supervision of the holder of the marketing authorisation;
n) all variations in the group are a consequence of the implementation of the condition in the permission for use under art. 56;
3. requested changes to the terms of the same permission for use does not fall within the cases referred to in paragraph 2, provided that the FDA has agreed to these changes, to apply the same procedure.
(4) upon grouping of changes under para. 3, item 2 and 3 the holder of the marketing authorisation submitted to the FDA:
1. single notification when at least one of the variations is a type IB and all the rest are type IA or type IB;
2. single application, when the main change is a type II and none of the other changes is not an extension of the marketing authorisation;
3. single application, when the main change was the extension of the scope of the permission for use.
(5) together with the application, the notification under paragraph 1 accordingly. 1 or 4, the holder of the marketing authorisation shall submit:
1. documentation associated with changes determined by the Ordinance under art. 42;
2. a document for paid fee fixed by the tariff referred to in art. 21, para. 2.
(6) the Executive Director of the FDA approve models of application, notification under paragraph 1. 1 and 4, which shall be published on the website of the FDA. "
§ 6. Article 62 is amended as follows:
"Art. 62. (1) the holder of the marketing authorisation holder may submit a notification for changes type IA within 12 months of their application with the exception of changes that require immediate notification.
(2) change the type IA that require immediate notification shall be determined by the Ordinance under art. 42.
(3) in the cases referred to in para. 2 the holder of the authorisation submits a notification about changing type IA immediately after its implementation.
(4) within 30 days of receipt of the notification under paragraph 1. 1, respectively, at para. 3, the FDA will notify the holder of the marketing authorisation:
1. whether the change/change is accepted/accepted or not; When the change/modify not accepted/accepted, stating the reasons therefor, and
2. whether the change/change leads/lead to change the data in the issued permission for use; When you have a change in the issued permission for use is applied art. 64. (5) the holder of the marketing authorisation holder shall immediately suspend the application of the relevant/corresponding changes/changes type IA after receipt of the notification under paragraph 1. 4, item 1 of non-acceptance. "
§ 7. Article 63 shall be amended as follows:
"Art. 63. (1) where the notification of the change type IB variation complies with the requirements of art. 61, the FDA will notify the holder of the marketing authorisation that is valid and the notification shall indicate the date from which the time limit under paragraph 1. 2 runs.
(2) within 30 days of receipt of a valid notification the FDA assesses the submitted documentation and shall inform the holder of the marketing authorisation holder:
1. does approve the change or not; When the change is not approved, shall state the reasons for it, and
2. If the change results in a change to the data in the issued permission for use; When you have a change in the issued permission for use is applied art. 64.
(3) where, within the period referred to in paragraph 1. 2 FDA finds discrepancies in the documentation supplied with the requirements of the law and the Ordinance under art. 42, it shall inform the holder of the marketing authorisation.
(4) within 30 days of receipt of the notification under paragraph 1. 3 the holder of the marketing authorisation may modify or supplement the documentation.
(5) where, within the period referred to in paragraph 1. 4 the holder of the authorisation holder does not submit the changed or supplemented documentation, the procedure terminates BDA and shall inform the holder of the marketing authorisation.
(6) within 30 days of receipt of the changed documentation under para. 4 the FDA will notify the holder of the marketing authorisation:
1. does approve the change or not; When the change is not approved, shall state the reasons for it, and
2. If the change results in a change to the data in the issued permission for use; When you have a change in the issued permission for use is applied art. 64.
(7) the holder of the marketing authorisation holder applies the approved changes type IB after receipt of the notification under paragraph 1. 2, paragraph 1, respectively, at para. 6, item 1 for approval of the change. "
§ 8. Article 64 shall be amended as follows:
"Art. 64. (1) where an application for type II change meets the requirements of art. 61, the FDA will notify the holder of the marketing authorisation for use, that the application is valid, stating the date on which the period under para. 2 runs.
(2) within 60 days of receipt of a valid application shall draw up an evaluation report on the FDA the change.
(3) the time limit referred to in paragraph 1. 2 may be:
1. reduced in urgent cases that are related to the safe use of the medicinal product, or
2. extended to 90 days for change, which amends or adds a therapeutic indication.
(4) When the FDA finds discrepancies in the documentation supplied with the requirements of the law and the Ordinance under art. 42, it shall inform the holder of the marketing authorisation and shall set a deadline for the provision of additional information and documentation.
(5) in the cases referred to in para. the time limit referred to in paragraph 4. 2 shall be suspended pending the submission of additional information and documentation.
(6) within 15 days of the preparation of the assessment report, the Executive Director of the BDA:
1. Approves the change or makes a reasoned refusal and shall inform the holder of the marketing authorisation;
2. notify the holder of the marketing authorisation if the approved change leads to a change of data in the issued permission for use; When you have a change in the issued permission for use is applied art. 64.
(7) the holder of the marketing authorisation may apply the approved change type II only after the granting of permission to change under art. 64. "
§ 9. Create art. 64 and 64 (b):
"Art. 64. The Executive Director of the BDA issue permission for a change in the permit for use within:
1.30 days of issuance of notification according to art. 62, para. 4, item 2, art. 63, para. 2, item 2, according to art. 63, para. 6, paragraph 2 or article. 64, para. 6, item 2, where the change results in an extension of six months of the period referred to in article 13 (1) and (2) of Regulation No 1768/92 (EEC) of 18 June 1992 concerning the creation of a supplementary protection certificate for medicinal products in accordance with art. 36 of Regulation (EC) no 1901/2006;
2.60 days of issuance of notification according to art. 62, para. 4, item 2 – changes type IA which do not require immediate notification;
3.60 days of issuance of notification according to art. 64, para. 6, item 2 – type II changes;
4. one hundred and eighty days – in all other cases.
Art. 64B. (1) in the event of changes relating to the changes in the active substance for the purposes of the annual update on flu vaccines, the holder of the marketing authorisation submitted to the FDA application, accompanied by the documents specified by the Ordinance under art. 42. Within 7 days the FDA checks the completeness of the submitted documentation.
(2) where an application meets the requirements of paragraphs 1 and 2. 1, the FDA will notify the holder of the marketing authorisation for use, that the application is valid, stating the date on which the period under para. 3 runs.
(3) within 45 days of the receipt of a valid application, the FDA evaluated documentation and shall draw up an evaluation report.
(4) the drug agency may require the marketing authorisation holder to submit clinical data and data on the stability of the medicinal product. The holder of the marketing authorisation submitted in the required data the FDA within 12 days from the expiry of the period referred to in para. 3.
(5) the drug agency assessed the documentation and make a final decision within 10 days of receipt of the data referred to in para. 4, issue the change permission or denial. "
§ 10. In art. 66 para. 1 shall be amended as follows:
(1) the holder of an authorisation for the use of the medicinal product shall submit an application for extension of a permit for use if:
1. change of the active/active substance/substances:
and the replacement of chemical) active substance complex/derivative with a different salt/ester, with the same therapeutic moiety where the efficacy/safety characteristics are not significantly different;
b) replacement by a different isomer, a different mixture of isomers, replacement of a mixture by an isolated isomer (e.g. racemate by a single enantiomer where the), where the efficacy/safety characteristics are not significantly different;
in replacement of) a biological active substance with one that has a slightly different molecular structure, where the efficacy/safety characteristics are not significantly different, with the exception of the changes to the active substance of seasonal, pre-pandemic or pandemic influenza vaccine for human use;
d) modification of the vector used to produce the Antigen or the source material, including a new major cell bank from a different source where the efficacy/safety characteristics are not significantly different;
(e)) a new ligand or coupling mechanism for a radiopharmaceutical, where the efficacy/safety characteristics are not significantly different;
is a change in solvent extraction) or herbal substance ratio/vegetable preparation where the efficacy/safety characteristics are not significantly different;
2. change in the quantity of the active substance formulation and route of entry:
a) change of bioavailability;
(b)) change in pharmacokinetics e.g. change in rate of release;
c) change or addition of a new quantity of active substance/activity;
d) change or addition of a new pharmaceutical form;
e) change or addition of a new route of administration – when parenteral is necessary to make a distinction between intraarterialen, intravenous, intramuscular, subcutaneous and other routes. "
§ 11. In art. 80, the words "Regulation (EC) no 1084/2003 of the European Commission" shall be replaced by ' Regulation (EC) No 1234/2008 of 24 November 2008 concerning the examination of variations to the terms of marketing authorisations for medicinal products for human use and veterinary medicinal products (OJ L 334/7 of 12 December 2008).
§ 12. In art. 114 Al is created. 4:
"(4) for the submission of applications for obtaining the opinion of the Ethics Committee Department of health collects a fee fixed by the tariff referred to in art. 21, para. 2. "
§ 13. In chapter IV, section IX "Neintervencionalno" survey "is replaced by" chapter four "and" Neintervencionalni ".
§ 14. In art. 145 following amendments and supplements shall be made:
1. In paragraph 8. 1 creating the second sentence: "participants in studies Of neintervencionalni do not apply diagnostic or monitoring procedures, different from usual practice, as for the analysis of the data obtained using epidemiological methods."
2. in the Al. 2 the words "the relevant Ethics Committee ' shall be replaced by" the Commission under art. 103, para. 1. "
3. Paragraph 3 is replaced by the following:
(3) Conducting of study neintervencionalno can start, if within one month of the submission in the BDA, respectively in the Commission under art. 103, para. 1, of the documents referred to in para. 2 the applicant does not receive explicit refusal by the Director of the BDA, accordingly negative opinion from the Commission under art. 103, para. 1. "
4. Al are created. 4, 5 and 6:
"(4) Neintervencionalni studies may be conducted in hospitals under art. 8, al. 1, paragraphs 1 and 2, art. 9 and art. 10, t. 1, 2 and 3 of the law on medical institutions.
(5) in the neintervencionalni studies can engage physicians and dental practitioners.
(6) Neintervencionalno research is conducted after informing the participants in it, except in cases in which is processed anonymously and retrospectively medical information. "
§ 15. In art. 160 following amendments and supplements shall be made:
1. In paragraph 8. 1:
a) in paragraph 4, the words ' according to medicinal products designed to test, in accordance with the "shall be replaced by the words" subject to ";
(b)) section 5 is repealed.
2. a para. 8:
"(8) on the basis of the manufacturing authorization issued under this section, the holder may carry out the import of active and Excipients, necessary for the manufacture of the medicinal products referred to in the manufacturing authorisation."
§ 16. In art. 163, para. 10 the words "item 4, 5, and 7 ' shall be replaced by ' paragraph 4 and 7.
§ 17. Art is created. 163:
"Art. 163. (1) where the FDA found shortcomings and deficiencies in the documentation provided, it shall inform the applicant in writing and give written instructions.
(2) in the cases referred to in para. 1 the term of art. 164, para. 1 stop running to bring the documentation in accordance with the requirements. "
§ 18. In art. 214, para. 2, the words "under the same name" shall be deleted.
§ 19. In art. 215, para. 2, item 3, finally a comma and add "of a medicinal product intended for parallel imports".
§ 20. In art. 223, para. 2, the words "or to work on another site" shall be deleted.
§ 21. In art. 230, para. 1, paragraph 3, the words "personal data and address" shall be replaced by "personal identification number".
§ 22. In art. 236, para. 2, first sentence, the words "temporary disability, pregnancy, childbirth or adoption and raising a child" shall be replaced by "temporary incapacity due to sickness, pregnancy and childbirth or adoption and leave for raising a small child under the labour code".
§ 23. In § 1 of the additional provisions are made the following amendments and additions:
1. In point 37:
a) in point (b), the words "the manufacturer" shall be replaced by "of the holder of the marketing authorisation. ';
(b)) in (c), the words "the manufacturer" shall be replaced by "of the holder of the marketing authorisation."
2. Create t. 89, 90 and 91:
"89." change type IA "is change with minimal impact or no impact on the quality, safety or efficacy of the medicinal product concerned.
90. "change type IB" is a change that is neither a type IA or type II change or extension of the authorization for use.
91. "change" type II is a change which extension of the scope of the authorisation and which may have a significant impact on the quality, safety or efficacy of the medicinal product concerned. "
Transitional and final provisions
§ 24. The submitted valid applications and notifications of changes in permissions for use prior to the entry into force of this law shall be dealt with in the previous row.
§ 25. Health Minister brought into conformity with this Act, the Ordinance under art. 42 within three months of its entry into force.
§ 26. In the law on the control of narcotic substances and precursors (promulgated, SG. 30 of 1999; amend., 63/2000, no. 74, 75 and 120 of 2002, no. 56 of 2003, issue 76, 79 and 103 by 2005, issue 30, 75 and 82 of 2006, no. 31 and 55 in 2007, issue 36, 43 and 69 since 2008. , PC. 41, 74, 82 and 93 from 2009, PCs. 22, 23, 29, 59 and 98 of 2010 and PC. 8 of 2011.) make the following changes and additions:
1. In art. 32 (b):
(a)) in the Al. 1:
AA) in item 2 Finally a comma and add "SIC";
BB) in paragraph 8, the words "and data of identity document" shall be deleted;
(b)) in the Al. 3 Add "and data of the identity of the responsible person referred to in art. 34 ".
2. In art. 33 (b):
(a)) in the Al. 1:
AA) in item 2 Finally a comma and add "SIC";
BB) in paragraph 7, the words "and data of identity document" shall be deleted;
(b)) in the Al. 3 Add "and data of the ID of pharmacists under art. 34 ".
3. In art. 47, para. 1 the words "laid down by the Minister" shall be replaced by ' laid down by Decree of the Minister of health ".
4. In art. 54, para. 2 words, "Ordinance of the Minister of health" are replaced by "the Ordinance under art. 47, para. 1. "
5. Annex 1 to the art. 3, al. 2 shall be amended as follows:
' Annex No 1 to art. 3, al. 2
Plants and substances with a high degree of risk to public health due to the harmful effects of the misuse of them, banned for use in human and veterinary medicine
a-methylamino-butirofenon (Bufedron)
Alpha-metilfentanil
Alpha-metiltiofentanil
Amphetamine
Aporfin
Acetyl-alpha-metilfentanil
Acetorfin 1-benzyl piperazine Beta-hydroxy-3-metilfentanil
Beta-bromo-hidroksifentanil benzodifuranil-izopropilamin (Bromo-DragonFLY)
4-bromo-2.5-dimetoksifenetilamin (2SV)
Brolamfetamin
1-butyl-3-(1-naftoil) indole (JWH-073)
Deksamfetamin
Delta-9-tetrahydrocannabinol and its isomers stereohimičeskite DET
Dezomorfin
DMA
DMHP
DMT
DOET Dimetokain (larokain)
2.5-dimethoxy-4-jodoamfetamin (DOI)
2.5-dimethoxy-4-jodofenetilamin (2C-I) 2.5-dimethoxy-4-etiltiofenetilamin (2C-T-2) 2.5-dimethoxy-4-(n)-propiltiofenetilamin (2C-T-7)
2.5-dimethoxy-4-hloramfetamin (DOC)
Etilamfetamin (N-etilamfetamin)
Eticiklidin
Etkatinon
M-99
Etriptamin
Cathinone
Ketobemidon
The coca bush
Hemp (marijuana)
Concentrate of poppy straw
Coca leaves
Levamfetamin
Levometamfetamin
(+)-lizergid
Poppy straw
MDMA
Mezokarb
Mescaline
Methamphetamine
4-metilaminoreks 1-methyl-4-benzylpiperazine (MBZP)
3.4-methylenedioxy-N-metilkatinon (bk-MDMA, metilon)
Metilendioksipirovaleron (MDPV)
3.4-methylenedioxy-a-pirolidinbutiofenon (MDPBP)
4-metiletkatinon (4-MEC)
4-methylmethcathinone (4-MMC, mephedrone)
4-methyl-a-pirolidinbutiofenon (MPBP)
4-metiltioamfetamin (4-MTA)
3-metiltiofentanil
3-metilfentanil
Metkatinon
4-methoxy-metkatinon (metedron)
MMDA
MPPP (MRRR)
Naftilpirovaleron (Nafiron)
N-ethyl MDA
N, N-dialil-5-methoxytryptamine (5-MEO-DALT)
N-hydroxy MDA
Opium
Opium
Steam-metoksimetamfetamin (PMMA)
Steam-fluorofentanil
Paraheksil
1-pentil-3-(4-methyl-1-naftoil) indole (JWH 122)
1-pentil-3-(2-metoksifenilacetil) indole (JWH 250)
1-pentil-3-(1-naftoil) indole (JWH-018)
Pepap (Rerar)
PMA
Psilocybin
Psilocin (psilotsin)
Methamphetamine racemate
Roliciklidin
STP (DOM)
Tenamfetamin
Tenociklidin
Tetrahydrocannabinol
Tiofentanil
TMA
2, 4, 5-trimetoksiamfetamin (TMA-2)
Fenetilin
Fenilpiperazin and its halogen derivatives 4-Fluorine-metkatinon (flefedron)
Hash
Cannabinoid oil
1-Hexyl-3-(1-naftoil) indole (JWH-019)
Heroin (Diacetylmorphine)
2-(3-hidroksicikloheksil)-5-(2-metiloktan-2-yl) phenol (CP 47.497) and its dimetilheksil, dimetiloktil and dimetilnonil homologues
4-chloro-2.5-dimetoksifenetilamin (2C-C)
and the isomers, esters, ethers and salts of substances included in this list, in all cases where these isomers, esters, ethers and salts (including those salts of esters, ethers and isomers) may exist. "
§ 27. The law shall enter into force on the day of its publication in the Official Gazette.
The law was adopted by 41-Otto National Assembly on 26 January 2011 and is stamped with the official seal of the National Assembly.
President of the National Assembly: Anastas Anastasov
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