CHAPTER IV

POST-MARKETING AUTHORISATION MEASURES
Section 3

Changes to the terms of the marketing authorisations

Work-sharing procedure
Article 65
1
When the marketing authorisation holder applies for one or more variations which are identical in all relevant Member States and which do not appear in the list established in accordance with Article 60(1) regarding several marketing authorisations which are held by the same marketing authorisation holder and which have been granted by different competent authorities or the Commission, that marketing authorisation holder shall submit an identical application to competent authorities in all relevant Member States and, where a variation to a centrally authorised veterinary medicinal product is included, to the Agency.
2
Where any of the marketing authorisations referred to in paragraph 1 of this Article is a centralised marketing authorisation, the Agency shall assess the application in accordance with the procedure laid down in Article 66.
3
Where none of the marketing authorisations referred to in paragraph 1 of this Article is a centralised marketing authorisation, the coordination group shall agree upon a competent authority among those having granted the marketing authorisations to assess the application in accordance with the procedure laid down in Article 66.
4
The Commission may, by means of implementing acts, adopt the necessary arrangements regarding the functioning of the worksharing procedure. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 145(2).