Small and medium-sized enterprises

Member States shall, in accordance with their national law, take appropriate measures to advise small and medium-sized enterprises on compliance with the requirements of this Regulation.

Section 3

Changes to the terms of the marketing authorisations

Article 60

Variations

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;

(d) whether changes are of an administrative nature.

Article 61

Variations that do not require assessment

1. Where a variation is included in the list established in accordance with Article 60(1), the marketing authorisation holder shall record the change including, as applicable, the summary of product characteristics, labelling or package leaflet in languages referred to in Article 7, in the product database within 30 days following the implementation of that variation.

2. If necessary, competent authorities or, where the veterinary medicinal product is authorised under the centralised marketing authorisation procedure, the Commission shall, by means of implementing acts, amend the marketing authorisation in accordance with the change recorded as referred to in paragraph 1 of this Article. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 145(2).

3. The competent authority of the reference Member State or, in the case of variation to the terms of a national marketing authorisation, the competent authority of the relevant Member State, or the Commission, as applicable, shall inform the marketing authorisation holder and the competent authorities in the relevant Member States as to whether the variation is approved or rejected by recording that information in the product database.

Article 62

Application for variations requiring assessment

1. Where a variation is not included in the list established in accordance with Article 60(1), the marketing authorisation holder shall submit an application for a variation requiring assessment to the competent authority which has granted the marketing authorisation or to the Agency, as applicable. The applications shall be submitted electronically.

2. The application referred to in paragraph 1 shall contain:

(a) a description of the variation;