Commission 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 (Text with EEA relevance)
Modified by
  • Commission Regulation (EU) No 712/2012of 3 August 2012amending 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), 32012R0712, August 4, 2012
  • Commission Delegated Regulation (EU) 2021/756of 24 March 2021amending 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), 32021R0756, May 10, 2021
Commission Regulation (EC) No 1234/2008of 24 November 2008concerning the examination of variations to the terms of marketing authorisations for medicinal products for human use and veterinary medicinal products(Text with EEA relevance) CHAPTER IGENERAL PROVISIONS
Article 1Subject matter and scope1.This Regulation lays down provisions concerning the examination of variations to the terms of all marketing authorisations for medicinal products for human use and veterinary medicinal products granted in accordance with Regulation (EC) No 726/2004, Directive 2001/83/EC, Directive 2001/82/EC, and Council Directive 87/22/EECOJ L 15, 17.1.1987, p. 38..2.This Regulation shall not apply to transfers of a marketing authorisation from one marketing authorisation holder (hereinafter holder) to another.3.Chapter II shall apply only to variations to the terms of marketing authorisations granted in accordance with Directive 87/22/EEC, Chapter 4 of Directive 2001/82/EC or Chapter 4 of Directive 2001/83/EC.3a.Chapter IIa shall apply only to variations to the terms of purely national marketing authorisations.4.Chapter III shall apply only to variations to the terms of marketing authorisations granted in accordance with Regulation (EC) No 726/2004 (hereinafter centralised marketing authorisations).
Article 2DefinitionsFor the purposes of this Regulation, the following definitions shall apply:1."Variation to the terms of a marketing authorisation" or "variation" means any amendment to:(a)the information referred to in Articles 12(3) to 14 of Directive 2001/82/EC and Annex I thereto, Articles 8(3) to 11 of Directive 2001/83/EC and Annex I thereto, Articles 6(2) and 31(2) of Regulation (EC) No 726/2004, or Article 7 of Regulation (EC) No 1394/2007;(b)the terms of the decision granting the marketing authorisation for a medicinal product for human use, including the summary of the product characteristics and any conditions, obligations, or restrictions affecting the marketing authorisation, or changes to the labelling or the package leaflet connected with changes to the summary of the product characteristics;(c)the terms of the decision granting the marketing authorisation for a veterinary medicinal product, including the summary of the product characteristics and any conditions, obligations, or restrictions affecting the marketing authorisation, or changes to the labelling or the package leaflet.2."Minor variation of type IA" means a variation which has only a minimal impact, or no impact at all, on the quality, safety or efficacy of the medicinal product concerned;3."Major variation of type II" means a variation which is not an extension and which may have a significant impact on the quality, safety or efficacy of the medicinal product concerned;4."Extension of a marketing authorisation" or "extension" means a variation which is listed in Annex I and fulfils the conditions laid down therein;5."Minor variation of type IB" means a variation which is neither a minor variation of type IA nor a major variation of type II nor an extension;6."Member State concerned" means a Member State whose competent authority has granted a marketing authorisation for the medicinal product in question;7."Relevant authority" means:(a)the competent authority of each Member State concerned;(b)in the case of centralised marketing authorisations, the Agency;8."Urgent safety restriction" means an interim change in the terms of the marketing authorisation due to new information having a bearing on the safe use of the medicinal product;9."Purely national marketing authorisation" means any marketing authorisation granted by a Member State in accordance with the acquis outside the mutual recognition or decentralised procedure and that has not been subject to a complete harmonisation following a referral procedure.
Article 3Classification of variations1.In relation to any variation which is not an extension the classification laid down in Annex II shall apply.2.A variation which is not an extension and whose classification is undetermined after application of the rules provided for in this Regulation, taking into account the guidelines referred to in Article 4(1) and, where relevant, any recommendations delivered pursuant to Article 5, shall by default be considered a minor variation of type IB.3.By way of derogation from paragraph 2, a variation which is not an extension and whose classification is undetermined after application of the rules provided for in this Regulation shall be considered a major variation of type II in the following cases:(a)upon request from the holder when submitting the variation;(b)where the competent authority of the reference Member State as referred to in Article 32 of Directive 2001/82/EC and Article 28 of Directive 2001/83/EC (hereinafter "the reference Member State"), in consultation with the other Member States concerned, or the Agency in the case of a centralised marketing authorisation, or the competent authority in the case of a purely national marketing authorisation, concludes, following the assessment of validity of a notification in accordance with Article 9(1), Article 13b(1), or Article 15(1) and taking into account the recommendations delivered pursuant to Article 5, that the variation may have a significant impact on the quality, safety or efficacy of the medicinal product concerned.
Article 4Guidelines1.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.
Article 5Recommendation on unforeseen variations1.Prior to the submission of a variation whose classification is not provided for in this Regulation, a holder may request a recommendation on the classification of the variation as follows:(a)to the Agency, where the variation refers to a marketing authorisation granted under Regulation (EC) No 726/2004;(b)to the competent authority of the Member State concerned, where the variation refers to a purely national marketing authorisation;(c)to the competent authority of the reference Member State, in the other cases.The recommendation referred to in the first subparagraph shall be consistent with the guidelines referred to in Article 4(1). It shall be delivered within 45 days following receipt of the request and sent to the holder, the Agency, and the coordination group referred to in Article 31 of Directive 2001/82/EC or in Article 27 of Directive 2001/83/EC.The 45-day period referred to in the second subparagraph may be extended by 25 days where the relevant authority deems it necessary to consult with the coordination group.1a.Prior to the examination of a variation whose classification is not provided for in this Regulation, a competent authority of a Member State may request a recommendation on the classification of the variation to the coordination group.The recommendation referred to in the first subparagraph shall be consistent with the guidelines referred to in Article 4(1). It shall be delivered within 45 days following receipt of the request and sent to the holder, the Agency, and the competent authorities of all Member States.2.The Agency and the two coordination groups referred to in paragraph 1 shall cooperate to ensure the coherence of the recommendations delivered in accordance with that paragraph and publish those recommendations after deletion of all information of commercial confidential nature.
Article 6Variations leading to the revision of product informationWhere a variation leads to the revision of the summary of product characteristics, labelling or package leaflet, this revision shall be considered as part of that variation.
Article 7Grouping of variations1.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:(a)where the same minor variation(s) of type IA to the terms of one or more marketing authorisations owned by the same holder are notified at the same time to the same relevant authority, a single notification as referred to in Article 8 or 14 may cover all such variations;(b)where several variations to the terms of the same marketing authorisation are submitted at the same time, a single submission may cover all such variations provided that the variations concerned fall within one of the cases listed in Annex III;(c)where several variations to the terms of the same marketing authorisation are submitted at the same time and the variations do not fall within one of the cases listed in Annex III, a single submission may cover all such variations provided that the competent authority of the reference Member State in consultation with the competent authorities of the Member States concerned or, in the case of a centralised marketing authorisation, the Agency agrees to such single submission.The submission referred to in subparagraphs (b) and (c) shall be made simultaneously to all relevant authorities by means of the following:(i)a single notification in accordance with Article 9 or 15 where at least one of the variations is a minor variation of type IB and the remaining variations are minor variations;(ii)a single application in accordance with Article 10 or 16 where at least one of the variations is a major variation of type II and none of the variations is an extension;(iii)a single application in accordance with Article 19 where at least one of the variations is an extension.
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