TITLE IIIMARKETING

F2CHAPTER 4Mutual recognition procedure and decentralised procedure

Annotations:

Article 39

1

Any application by the marketing authorization holder to vary a marketing authorization which has been granted in accordance with the provisions of this Chapter shall be submitted to all the Member States which have previously authorized the veterinary medicinal product concerned.

The Commission shall, in consultation with the Agency, adopt appropriate arrangements for the examination of variations to the terms of a marketing authorization.

F1. . . . .

These arrangements shall be adopted by the Commission in the form of an implementing regulation in accordance with the procedure referred to in Article 89(2).

2

In case of arbitration submitted to the Commission, the procedure laid down in Articles 36, 37 and 38 shall apply by analogy to variations made to marketing authorizations.