Commission Delegated Regulation (EU) 2024/1701 of 11 March 2024 amending Regulation (EC) No 1234/2008 as regards the examination of variations to the terms of marketing authorisations for medicinal products for human use

‘1 This Regulation lays down provisions concerning the examination of variations to the terms of marketing authorisations for medicinal products for human use granted in accordance with Regulation (EC) No 726/2004 or Directive 2001/83/EC.’

‘3 Chapter II shall apply only to variations to the terms of marketing authorisations granted in accordance with Chapter 4 of Directive 2001/83/EC.’

‘6a “Reference authority” means: (a) the Agency where at least one of the marketing authorisations concerned is a centralised marketing authorisation; (b) the competent authority of the Member State chosen by the holder and accepted by that competent authority, or chosen by the coordination group referred to in Article 27 of Directive 2001/83/EC if none of the competent authorities of the Member States agrees to act as the reference authority, in the other cases;’

‘3 The Commission may publish the electronic version of the guidelines on its website. This electronic version may include new classification of variations and necessary updates to the guidelines before the regular update pursuant to paragraph 2.’

‘1 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) from the Agency, where the variation refers to a marketing authorisation granted under Regulation (EC) No 726/2004; (b) from the competent authority of the Member State concerned, where the variation refers to a purely national marketing authorisation; (c) from the competent authority of the reference Member State, in the other cases. Where a recommendation is requested from the Agency as set out in the first subparagraph, point (a), it shall consult the coordination group if the recommendation is expected to result in a new classification of variation. Where a recommendation is requested from the competent authority of the Member State concerned or of the reference Member State as set out in the first subparagraph, points (b) and (c), the relevant authority shall consult the coordination group and the Agency, if the recommendation is expected to result in a new classification of variation. The recommendations shall be consistent with the guidelines referred to in Article 4(1). It shall be delivered within 60 days following receipt of the request and sent to the holder, the Agency, and the coordination group.’

‘3 The recommendation referred to in paragraph 1 that results in a new classification of variation shall be regularly integrated in the guidelines referred to in Article 4(1) in accordance with Article 4(2), third subparagraph.’

For certain changes to the chemical, pharmaceutical and biological information for a medicinal product a holder may rely on a range of process parameters, quality attributes, protocols or summary documents, upon agreement of the relevant authority and subject to the conditions referred to in the Annexes and the guidelines referred to in Article 4(1) with regard to the specific regulatory tool.’

1 By way of derogation from Articles 7 and 13d, the holder may submit a single notification of variations to the terms of more than one marketing authorisation referred to in Chapters II, IIa and III owned by the same holder where the same or several minor variations of type IA referred to in Article 8, Article 13a or Article 14 are notified at the same time and fall within one of the cases of super-grouping of variations listed in the guidelines referred to in Article 4(1) (“super-grouping”).

2 A single notification as referred to in paragraph 1 shall be made simultaneously to the reference authority and all relevant authorities.’

1 By way of derogation from Chapters I, II, IIa and III, where a public health emergency at Union level is recognised by the Commission pursuant to Regulation (EU) 2022/2371 of the European Parliament and of the Council the relevant authorities, or in the case of centralised marketing authorisations, the Commission may, where certain pharmaceutical, non-clinical or clinical data are missing, exceptionally and temporarily accept a variation to the terms of a marketing authorisation for a human vaccine pertaining to the pathogen causing the public health emergency.

2 The relevant authority may request the holder to provide supplementary information in order to complete its assessment within a time limit set by it.

3 Variations may be accepted pursuant to paragraph 1 only if the benefit-risk balance of the medicinal product is favourable.

4 Where a variation is accepted pursuant to paragraph 1, the holder shall submit the missing pharmaceutical, non-clinical and clinical data within a time limit set by the relevant authority.

5 In the case of centralised marketing authorisations, the missing data and the time limit for submission or compliance shall be specified in the conditions to the marketing authorisation. Where the marketing authorisation has been granted in accordance with Article 14-a of Regulation (EC) No 726/2004 this may be done as part of the specific obligations referred to in paragraph 4 of that Article.

This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union. It shall apply from 1 January 2025.