Commission Delegated Regulation (EU) 2021/756 of 24 March 2021 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)

1 By way of derogation from Chapters I, II, IIa and III, where a pandemic situation with respect to human influenza or human coronavirus is duly recognised by the World Health Organization or by the Union in the framework of Decision No 1082/2013/EU 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 influenza vaccine or a human coronavirus vaccine.

2 The relevant authority may request the applicant 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 third day following that of its publication in the Official Journal of the European Union.