Pandemic situation with respect to human influenza and human coronavirus
Article 1
Open ↗Regulation (EC) No 1234/2008 is amended as follows: (1) Article 21 is replaced by the following ‘Article 21 Pandemic situation with respect to human influenza and human coronavirus (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 ( *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 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. ( *1 ) Decision No 1082/2013/EU of the European Parliament and of the Council of 22 October 2013 on serious cross-border threats to health and repealing Decision No 2119/98/EC ( OJ L 293, 5.11.2013, p. 1 ).’ " (2) In point (a) of Article 23(1 a ) the following point (ix) is added: ‘(ix) variations related to changes to the active substance of a human coronavirus vaccine, including replacement or addition of a serotype, strain, antigen or coding sequence or combination of serotypes, strains, antigens or coding sequences;’ (3) In point 1 of Annex I, point (c) is replaced by the following: ‘(c) replacement of a biological active substance with one of a slightly different molecular structure where the efficacy and/or safety characteristics are not significantly different, with the exception of: — changes to the active substance of a seasonal, pre-pandemic or pandemic vaccine against human influenza; — replacement or addition of a serotype, strain, antigen or coding sequence or combination of serotypes, strains, antigens or coding sequences for a human coronavirus vaccine; — replacement or addition of a serotype, strain, antigen or combination of serotypes, strains or antigens for a veterinary vaccine against avian influenza, foot-and-mouth disease or bluetongue; — replacement of a strain for a veterinary vaccine against equine influenza;’ (4) In point 2 of Annex II the following point (l) is added: ‘(l) variations related to the replacement or addition of a serotype, strain, antigen or coding sequence or combination of serotypes, strains, antigens or coding sequences for a human coronavirus vaccine.’