Regulation (EU) 2019/6 of the European Parliament and of the CouncilDangos y teitl llawn

Article 102 Parallel trade in veterinary medicinal products

1. For the purpose of parallel trade in veterinary medicinal products, the wholesale distributor shall ensure that the veterinary medicinal product it intends to obtain from a Member State (‘source Member State’) and distribute in another Member State (‘destination Member State’) share a common origin with the veterinary medicinal product already authorised in the destination Member State. The veterinary medicinal products are considered as sharing a common origin if they fulfil all the following conditions:

(a) they have the same qualitative and quantitative composition in terms of active substances and excipients;

(b) they have the same pharmaceutical form;

(c) they have the same clinical information and, if applicable, withdrawal period; and

(d) they have been manufactured by the same manufacturer or by a manufacturer working under licence according to the same formulation.

2. The veterinary medicinal product obtained from a source Member State shall comply with the labelling and language requirements of the destination Member State.

3. Competent authorities shall lay down administrative procedures for the parallel trade in veterinary medicinal products and administrative procedure for the approval of the application for parallel trade in such products.

4. Competent authorities of the destination Member State shall, in the product database as referred to in Article 55, make available to public the list of veterinary medicinal products that are parallel traded in that Member State.

5. A wholesale distributor that is not the marketing authorisation holder shall notify the marketing authorisation holder and the competent authority of the source Member State of its intention to parallel trade the veterinary medicinal product to a destination Member State.

6. Each wholesale distributor intending to parallel trade a veterinary medicinal product to a destination Member State shall comply with at least the following obligations:

(a) submit a declaration to the competent authority in the destination Member State and take appropriate measures to ensure that the wholesale distributor in the source Member State will keep it informed of any pharmacovigilance issues;

(b) notify the marketing authorisation holder in the destination Member State about the veterinary medicinal product to be obtained from the source Member State and intended to be placed on the market in the destination Member State at least one month prior to submitting to the competent authority the application for parallel trade in that veterinary medicinal product;

(c) submit a written declaration to the competent authority of the destination Member State that the marketing authorisation holder in the destination Member State was notified in accordance with point (b) together with a copy of that notification;

(d) not trade a veterinary medicinal product which has been recalled from the market of the source Member State or destination Member State for quality, safety or efficacy reasons;

(e) collect suspected adverse events and report them to the marketing authorisation holder of the parallel-traded veterinary medicinal product.

7. The following information shall be attached to the list referred to in paragraph 4 in respect of all veterinary medicinal products:

(a) name of the veterinary medicinal products;

(b) active substances;

(c) pharmaceutical forms;

(d) classification of the veterinary medicinal products in the destination Member State;

(e) marketing authorisation number of the veterinary medicinal products in the source Member State;

(f) marketing authorisation number of the veterinary medicinal products in the destination Member State;

(g) name or company name and permanent address or registered place of business of the wholesale distributor in the source Member State and of the wholesale distributor in the destination Member State.

8. This Article shall not apply to centrally authorised veterinary medicinal products.