CHAPTER IVPOST-MARKETING AUTHORISATION MEASURES

Section 3 Changes to the terms of the marketing authorisations

Article 60Variations

1.

The Commission shall, by means of implementing acts, establish a list of variations not requiring assessment. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 145(2).

2.

The Commission shall take account of the following criteria when adopting the implementing acts referred to in paragraph 1:

(a)

the need for a scientific assessment of changes in order to determine the risk to public or animal health or to the environment;

(b)

whether changes have an impact on the quality, safety or efficacy of the veterinary medicinal product;

(c)

whether changes imply no more than a minor alteration to the summary of product characteristics;

(d)

whether changes are of an administrative nature.