Regulation (EU) 2019/6 of the European Parliament and of the CouncilShow full title

Section 1 General provisions

Article 5 Marketing authorisations

1. A veterinary medicinal product shall be placed on the market only when a competent authority or the Commission, as applicable, has granted a marketing authorisation for that product in accordance with Article 44, 47, 49, 52, 53 or 54.

2. A marketing authorisation for a veterinary medicinal product shall be valid for an unlimited period of time.

3. Decisions to grant, refuse, suspend, revoke or amend by way of a variation a marketing authorisation shall be made public.

4. A marketing authorisation for a veterinary medicinal product shall only be granted to an applicant established in the Union. The requirement to be established in the Union shall also apply to marketing authorisation holders.

5. A marketing authorisation for a veterinary medicinal product intended for one or more food-producing animal species may only be granted if the pharmacologically active substance is allowed in accordance with Regulation (EC) No 470/2009 and any acts adopted on the basis thereof for the animal species concerned.

6. In the case of veterinary medicinal products intended for animals which are exclusively kept as pets: aquarium or pond animals, ornamental fish, cage birds, homing pigeons, terrarium animals, small rodents, ferrets and rabbits, Member States may allow exemptions from this Article, provided that such veterinary medicinal products are not subject to a veterinary prescription and that all necessary measures are in place in the Member State to prevent unauthorised use of those veterinary medicinal products for other animals.

Article 6 Submission of applications for marketing authorisations

1. Applications for marketing authorisations shall be submitted to the competent authority where they concern the granting of marketing authorisations in accordance with any of the following procedures:

(a) the national procedure laid down in Articles 46 and 47;

(b) the decentralised procedure laid down in Articles 48 and 49;

(c) the mutual recognition procedure laid down in Articles 51 and 52;

(d) the subsequent recognition procedure laid down in Article 53.

2. Applications for marketing authorisations shall be submitted to the Agency where they concern the granting of marketing authorisations in accordance with the centralised marketing authorisation procedure laid down in Articles 42 to 45.

3. Applications referred to in paragraphs 1 and 2 shall be submitted electronically and the formats made available by the Agency shall be used.

4. The applicant shall be responsible for the accuracy of the information and documentation submitted with respect to its application.

5. Within 15 days of receipt of the application, the competent authority or the Agency, as applicable, shall notify the applicant as to whether all the information and documentation required in accordance with Article 8 have been submitted and whether the application is valid.

6. Where the competent authority or the Agency, as applicable, considers that the application is incomplete, it shall inform the applicant accordingly and shall set a time limit for submitting the missing information and documentation. If the applicant fails to provide the missing information and documentation within the time limit set, the application shall be considered to have been withdrawn.

7. If the applicant fails to provide a complete translation of the required documentation within a period of six months after having received the information referred to in Article 49(7), 52(8) or 53(2), the application shall be considered to have been withdrawn.

Article 7 Languages

1. The language or languages of the summary of the product characteristics and the information on the labelling and on the package leaflet shall, unless the Member State determines otherwise, be an official language or languages of the Member State where the veterinary medicinal product is made available on the market.

2. Veterinary medicinal products may be labelled in several languages.