Article 21: Public health emergency

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 ( 1 ) 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.