variation
as defined in Proposal for a DIRECTIVE OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on the…, Article 4(1), point (54)
(54)‘variation’ or ‘variation of the terms of a marketing authorisation’ means any amendment to:
(a)the contents of the particulars and documents referred to in Article 6(2), Articles 9 to 14 and Article 62, Annex I and Annex II thereto and Article 6 of the [revised Regulation (EC) No 726/2004]; or
(b)the terms of the decision granting the marketing authorisation for a medicinal product, including the summary of product characteristics and any conditions, obligations, or restrictions affecting the marketing authorisation, or changes to the labelling or the package leaflet related to changes to the summary of product characteristics;
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Also defined in
- Regulation (EU) 2019/6 of the European Parliament and of the Council of 11 December 2018 on veterinary medicinal… 32019R0006, Article 4, point (39)
a change to the terms of the marketing authorisation for a veterinary medicinal product as referred to in Article 36;