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Document 32012R0712
Commission Regulation (EU) No 712/2012 of 3 August 2012 amending Regulation (EC) No 1234/2008 concerning the examination of variations to the terms of marketing authorisations for medicinal products for human use and veterinary medicinal products Text with EEA relevance
Commission Regulation (EU) No 712/2012 of 3 August 2012 amending Regulation (EC) No 1234/2008 concerning the examination of variations to the terms of marketing authorisations for medicinal products for human use and veterinary medicinal products Text with EEA relevance
Commission Regulation (EU) No 712/2012 of 3 August 2012 amending Regulation (EC) No 1234/2008 concerning the examination of variations to the terms of marketing authorisations for medicinal products for human use and veterinary medicinal products Text with EEA relevance
OJ L 209, 4.8.2012, p. 4–14
(BG, ES, CS, DA, DE, ET, EL, EN, FR, IT, LV, LT, HU, MT, NL, PL, PT, RO, SK, SL, FI, SV) This document has been published in a special edition(s)
(HR)
In force
4.8.2012 |
EN |
Official Journal of the European Union |
L 209/4 |
COMMISSION REGULATION (EU) No 712/2012
of 3 August 2012
amending Regulation (EC) No 1234/2008 concerning the examination of variations to the terms of marketing authorisations for medicinal products for human use and veterinary medicinal products
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Directive 2001/82/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to veterinary medicinal products (1), and in particular Article 27b thereof,
Having regard to 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 (2), and in particular Article 23b(1) thereof,
Having regard to Regulation (EC) No 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 Medicines Agency (3), and in particular Article 16(4) and Article 41(6) thereof,
Whereas:
(1) |
Directive 2009/53/EC of the European Parliament and of the Council of 18 June 2009 amending Directive 2001/82/EC and Directive 2001/83/EC, as regards variations to the terms of marketing authorisations for medicinal products (4), requires the Commission to adopt appropriate arrangements for the examination of variations to the terms of marketing authorisations granted in accordance with Directives 2001/82/EC and 2001/83/EC not yet covered by Commission Regulation (EC) No 1234/2008 (5). It is therefore appropriate to extend the scope of Regulation (EC) No 1234/2008. The variations of all marketing authorisations granted in the EU in accordance with the acquis should be subject to the procedures laid down in Regulation (EC) No 1234/2008. |
(2) |
The definition of variation should be clarified and updated in particular to take into consideration the provisions of Regulation (EU) No 1235/2010 of the European Parliament and of the Council of 15 December 2010 amending, as regards pharmacovigilance of medicinal products for human use, Regulation (EC) No 726/2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency, and Regulation (EC) No 1394/2007 on advanced therapy medicinal products (6), and the provisions of Directive 2010/84/EU of the European Parliament and of the Council of 15 December 2010 amending, as regards pharmacovigilance, Directive 2001/83/EC on the Community code relating to medicinal products for human use (7). |
(3) |
For reasons of consistency and with a view to reducing the administrative burden, variations to purely national marketing authorisations should be processed in accordance with the same principles that apply to variations of marketing authorisations granted under the mutual recognition procedure and the decentralised procedure. However, the possibilities for grouping variations should be adapted to the specific characteristics of purely national marketing authorisations. |
(4) |
It should be possible to process variations to purely national marketing authorisations in accordance with the worksharing procedure under certain conditions. Where the use of the worksharing procedure has lead to the harmonisation of a section of the summary of product characteristics, it should not be possible for the holder to later undermine the harmonisation achieved by submitting applications for variations to the section thus harmonised in some of the concerned Member States only. |
(5) |
Grouping of several variations in a single submission is possible in some cases. It should be clarified that, where several variations are grouped, the procedure for the handling of the variations in the group and the rules for the implementation of those variations should be those of the variation of the highest grade. In order to facilitate the acceptance of complex groupings by the relevant authorities, it should be possible to extend the assessment period. |
(6) |
The worksharing procedure is intended to avoid duplication of work. Accordingly, it should be possible for competent authorities to process under the same procedure variations to purely national marketing authorisations, variations to marketing authorisations granted under the mutual recognition or decentralised procedure, and variations to centralised marketing authorisations. |
(7) |
The procedure for the variation of human influenza vaccines should be streamlined. Competent authorities should still be able to start the assessment in the absence of clinical and stability data and take a decision if no additional information is considered necessary. However, if clinical and stability data is requested, the competent authorities should not be required to take a decision until the assessment thereof has been finalised. |
(8) |
For medicinal products authorised under Regulation (EC) No 726/2004, the refusal of the European Medicines Agency to accept a variation should terminate the procedure. Likewise, a Commission decision should not be required regarding variations that do not amend the terms of the decision granting the marketing authorisation. |
(9) |
The European Medicines Agency has the expertise to assess the need for urgent safety restrictions regarding medicinal products authorised under the centralised procedure. Marketing authorisation holders of medicinal products authorised under Regulation (EC) No 726/2004 should therefore inform the Agency if they consider that urgent safety measures are necessary. |
(10) |
A proliferation of variation procedures leading to frequent changes in the terms of the decision granting the marketing authorisation for centralised marketing authorisations has been identified. Changes that are critical for public health should be reflected in the decision granting the marketing authorisation promptly. However, other changes should be reflected in the decision granting the marketing authorisation according to timelines that ensure reasonable periodic updates of the decision granting the marketing authorisations while facilitating the identification of variations with the greatest impact on public health. |
(11) |
The principles governing the implementation of variations should be adjusted while keeping the principle that it should be possible for the marketing authorisation holder to implement certain variations prior to the relevant marketing authorisation being changed. |
(12) |
The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Medicinal Products for Human Use and the Standing Committee on Veterinary Medicinal Products, |
HAS ADOPTED THIS REGULATION:
Article 1
Amendments to Regulation (EC) No 1234/2008
Regulation (EC) No 1234/2008 is amended as follows:
(1) |
Article 1 is amended as follows:
|
(2) |
Article 2 is amended as follows:
|
(3) |
Article 3 is amended as follows:
|
(4) |
Article 4 is replaced by the following: ‘Article 4 Guidelines 1. The Commission shall, after consulting the Member States and the Agency, draw up guidelines on the details of the various categories of variations, on the operation of the procedures laid down in Chapters II, IIa, III and IV of this Regulation, and on the documentation to be submitted pursuant to those procedures. 2. The guidelines referred to in paragraph 1 shall be regularly updated.’; |
(5) |
Article 5 is amended as follows:
|
(6) |
Article 7 is replaced by the following: ‘Article 7 Grouping of variations 1. Where several variations are notified or applied for, a separate notification or application in accordance with Chapters II, III, or Article 19 as appropriate shall be submitted in respect of each variation sought. 2. By way of derogation from paragraph 1, the following shall apply:
The submission referred to in subparagraphs (b) and (c) shall be made simultaneously to all relevant authorities by means of the following:
|
(7) |
in Article 9, the following paragraph 5 is added: ‘5. This Article shall not apply where a type IB variation request is submitted in a grouping that includes a variation type II and does not contain an extension. In such case, the prior approval procedure in Article 10 shall apply. This Article shall not apply where a type IB variation request is submitted in a grouping that includes an extension. In such case, the procedure in Article 19 shall apply.’; |
(8) |
Article 10 is amended as follows:
|
(9) |
Article 12 is amended as follows:
|
(10) |
the following Chapter IIa is inserted after Article 13: ‘CHAPTER IIa VARIATIONS TO PURELY NATIONAL MARKETING AUTHORISATIONS Article 13a Notification procedure for minor variations of type IA 1. Where a minor variation of type IA is made, the holder shall submit to the competent authority a notification containing the elements listed in Annex IV. This notification shall be submitted within 12 months following the implementation of the variation. However, the notification shall be submitted immediately after the implementation of the variation in the case of minor variations requiring immediate notification for the continuous supervision of the medicinal product concerned. 2. Within 30 days following receipt of the notification, the measures provided for in Article 13e shall be taken. Article 13b Notification procedure for minor variations of type IB 1. The holder shall submit to the competent authority a notification containing the elements listed in Annex IV. If the notification fulfils the requirement laid down in the first subparagraph, the competent authority shall acknowledge receipt of a valid notification. 2. If within 30 days following the acknowledgement of receipt of a valid notification, the competent authority has not sent the holder an unfavourable opinion, the notification shall be deemed accepted by the competent authority. Where the notification is accepted by the competent authority, the measures provided for in Article 13e shall be taken. 3. Where the competent authority is of the opinion that the notification cannot be accepted, it shall inform the holder, stating the grounds on which its unfavourable opinion is based. Within 30 days following the receipt of the unfavourable opinion, the holder may submit to the competent authority an amended notification in order to take due account of the grounds laid down in that opinion. If the holder does not amend the notification in accordance with the second subparagraph, the notification shall be deemed rejected. 4. Where an amended notification has been submitted, the competent authority shall assess it within 30 days following its receipt and the measures provided for in Article 13e shall be taken. 5. This Article shall not apply where a type IB variation request is submitted in a grouping that includes a variation type II and does not contain an extension. In such case, the prior approval procedure in Article 13c shall apply. This Article shall not apply where a type IB variation request is submitted in a grouping that includes an extension. In such case, the procedure in Article 19 shall apply. Article 13c “Prior Approval” procedure for major variations of type II 1. The holder shall submit to the competent authority an application containing the elements listed in Annex IV. If the application fulfils the requirements laid down in the first subparagraph, the competent authority shall acknowledge receipt of a valid application. 2. Within 60 days following the acknowledgement of receipt of a valid application, the competent authority shall conclude the assessment. The competent authority may reduce the period referred to in the first subparagraph, having regard to the urgency of the matter, or extend it to 90 days for variations listed in Part 1 of Annex V or for grouping of variations in accordance with Article 13d(2)(c). The period referred to in the first subparagraph shall be 90 days for variations listed in Part 2 of Annex V. 3. Within the periods referred to in paragraph 2, the competent authority may request the holder to provide supplementary information within a time limit set by the competent authority. In this case the procedure shall be suspended until such supplementary information has been provided and the competent authority may extend the period referred to in paragraph 2. 4. Within 30 days after the conclusion of the assessment, the measures provided for in Article 13e shall be taken. 5. This Article shall not apply where a type II variation request is submitted in a grouping that includes an extension. In such case, the procedure in Article 19 shall apply. Article 13d Grouping of variations to purely national marketing authorisations 1. Where several variations are notified or applied for, a separate notification or application in accordance with Articles 13a, 13b, 13c, or 19 as appropriate shall be submitted to the competent authority in respect of each variation sought. 2. By way of derogation from paragraph 1 the following shall apply:
The submission referred to in points (b) and (c) shall be made by means of the following:
Article 13e Measures to close the procedures of Articles 13a to 13c Where reference is made to this Article, the competent authority shall take the following measures:
Article 13f Human influenza vaccines 1. By way of derogation from Article 13c, the procedure laid down in paragraphs 2 to 4 shall apply to the examination of variations concerning changes to the active substance for the purposes of the annual update of a human influenza vaccine. 2. The holder shall submit to the competent authority an application containing the elements listed in Annex IV. If the application fulfils the requirements laid down in the first subparagraph, the competent authority shall acknowledge receipt of a valid application. 3. The competent authority shall assess the application submitted. Where deemed necessary, the competent authority may request additional data to the holder in order to complete its assessment. 4. The competent authority shall adopt a decision within 45 days from the receipt of a valid application and shall take the measures provided for in Article 13e. The 45-day period referred to in the first subparagraph shall be suspended from the moment when the additional data referred to in paragraph 3 is requested until the data is submitted.’; |
(11) |
Article 15 is amended as follows:
|
(12) |
Article 16 is amended as follows:
|
(13) |
Article 17 is replaced by the following: ‘Article 17 Measures to close the procedures of Articles 14 to 16 1. Where reference is made to this Article, the Agency shall take the following measures:
2. In the cases identified under paragraph 1(c), the Commission, having regard to the opinion from the Agency and within the time limit foreseen in Article 23(1a), shall amend where necessary the decision granting the marketing authorisation. The Community Register of Medicinal Products provided for in Article 13(1) and Article 38(1) of Regulation (EC) No 726/2004 shall be updated accordingly.’; |
(14) |
Article 18 is amended as follows:
|
(15) |
Article 20 is amended as follows:
|
(16) |
in Article 21, paragraph 1 is replaced by the following: ‘1. By way of derogation from Chapters I, II, IIa and III, where a pandemic situation with respect to human influenza is duly recognised by the World Health Organisation or by the Union in the framework of Decision 2119/98/EC of the European Parliament and of the Council (*2), the relevant authorities or, in the case of centralised marketing authorisations, the Commission may exceptionally and temporarily accept a variation to the terms of a marketing authorisation for a human influenza vaccine, where certain non-clinical or clinical data are missing. |
(17) |
in Article 22, paragraph 1 is replaced by the following: ‘1. Where, in the event of a risk to public health in the case of medicinal products for human use or, in the case of veterinary medicinal products, in the event of a risk to human or animal health or to the environment, the holder takes urgent safety restrictions on its own initiative, it shall forthwith inform all relevant authorities and, in the case of a centralised marketing authorisation, the Agency. If the relevant authority or, in the case of a centralised marketing authorisation, the Agency has not raised objections within 24 hours following receipt of that information, the urgent safety restrictions shall be deemed accepted.’; |
(18) |
Article 23 is amended as follows:
|
(19) |
the following Article 23a is inserted after Article 23: ‘Article 23a The statement indicating compliance with the agreed completed paediatric investigation plan provided for under Article 28(3) of Regulation (EC) No 1901/2006 shall be included within the technical dossier of the marketing authorisation. The relevant authority shall provide the holder with a confirmation that the statement is included in the technical dossier within 30 days after the relevant assessment has been concluded.’; |
(20) |
Article 24 is replaced by the following: ‘Article 24 Implementation of variations 1. Minor variations of type IA may be implemented any time before completion of the procedures laid down in Articles 8, 13a and 14. Where a notification concerning one or several minor variations of type IA is rejected, the holder shall cease to apply the concerned variation(s) immediately after receipt of the information referred to in Articles 11(1)(a), 13e(a), and 17(1)(a). 2. Minor variations of type IB may only be implemented in the following cases:
3. Major variations of type II may only be implemented in the following cases:
4. An extension may only be implemented after the relevant authority or, in the case of extensions to a centralised marketing authorisation, the Commission has amended the decision granting the marketing authorisation and notified the holder accordingly. 5. Urgent safety restrictions and variations which are related to safety issues shall be implemented within a time frame agreed by the holder and the relevant authority and, in the case of a centralised marketing authorisation, the Agency. By way of derogation from the first subparagraph, urgent safety restrictions and variations related to safety issues which concern marketing authorisations granted in accordance with Chapter 4 of Directive 2001/82/EC or Chapter 4 of Directive 2001/83/EC shall be implemented within a time frame agreed by the holder and the competent authority of the reference Member State, in consultation with the other relevant authorities.’; |
(21) |
the title of Annex III is replaced by the following: ‘ Cases for grouping variations referred to in Article 7(2)(b) and Article 13d(2)(b) ’; |
(22) |
the following Article 24a is inserted after Article 24: ‘Article 24a Application of national provisions on variations to purely national marketing authorisations Member States that, in accordance with Article 23b(4) of Directive 2001/83/EC, may continue to apply their national provisions on variations to certain purely national marketing authorisations are listed in Annex VI to this Regulation.’; |
(23) |
the Annex set out in the Annex to this Regulation is added. |
Article 2
Transitional arrangements
From 2 November 2012, the following changes shall apply:
(a) |
in Article 23(1) of Regulation (EC) No 1234/2008, the reference to ‘Chapters II and III’ is replaced by ‘Chapter II’; |
(b) |
in Article 23(1) of Regulation (EC) No 1234/2008, subparagraph (a) is deleted. |
Article 3
Entry into force and application
1. This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
2. It shall apply from 2 November 2012.
However, points (10), (15), (18)(a) and (c), (21), (22) and (23) of Article 1 shall apply from 4 August 2013.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 3 August 2012.
For the Commission
The President
José Manuel BARROSO
(1) OJ L 311, 28.11.2001, p. 1.
(2) OJ L 311, 28.11.2001, p. 67.
(3) OJ L 136, 30.4.2004, p. 1.
(4) OJ L 168, 30.6.2009, p. 33.
(5) OJ L 334, 12.12.2008, p. 7.
ANNEX
‘ANNEX VI
List of Member States referred in Article 24a
the Republic of Bulgaria, |
the Federal Republic of Germany.’ |