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:

(4) Article 4 is replaced by the following: ‘Article 4 Guidelines

(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.’;

(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. (2) OJ L 268, 3.10.1998, p. 1.’;"

(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.’;

(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.’;

(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

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.

(6) OJ L 348, 31.12.2010, p. 1.

(7) OJ L 348, 31.12.2010, p. 74.