1. Amendments to the decision granting the marketing authorisation resulting from the procedures laid down in Chapters II and IIa shall be made:
(a) in the case of major variations of type II, within two months following receipt of the information referred to in
Article 11(1)(c) and
Article 13e(a), provided that the documents necessary for the amendment of the marketing authorisation have been transmitted to the Member States concerned;
(b) in the other cases, within six months following receipt of the information referred to in
Article 11(1)(c) and
Article 13e(a), provided that the documents necessary for the amendment of the marketing authorisation have been transmi tted to the Member States concerned.
1a. Amendments to the decision granting the marketing authorisation resulting from the procedures laid down in Chapter III shall be made:
(a) within two months following receipt of the information referred to in
Article 17(1)(c) for the following variations:
(i) variations related to the addition of a new therapeutic indication or to the modification of an existing one;
(ii) variations related to the addition of a new contraindication;
(iii) variations related to a change in posology;
(vi) variations related to changes to the active substance of a seasonal, pre-pandemic or pandemic vaccine against human influenza;
(viii) other type II variations that are intended to implement changes to the decision granting the marketing authorisation due to a significant public health concern;
(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;
(x) variations related to the replacement or addition of a serotype, strain, antigen or coding sequence or combination of serotypes, strains, antigens or coding sequences of a human vaccine that has the potential to address a public health emergency;
(b) within 12 months following receipt of the information referred to in Article 17(1)(c) in the other cases.
The Agency shall determine the variations referred to in point (a)(viii) and provide reasons for such determination.
2. Where the decision granting a marketing authorisation is amended as a result of one of the procedures laid down in Chapters II, IIa, III and IV, the relevant authority or, in the case of centralised marketing authorisations, the Commission shall notify the amended decision without delay to the holder.