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

Article 40 U.K. Prolongation and additional periods of the protection of technical documentation

1. Where the first marketing authorisation is granted for more than one animal species referred to in point (a) or (b) of Article 39(1) or a variation is approved in accordance with Article 67 extending the marketing authorisation to another species referred to in point (a) or (b) of Article 39(1), the period of the protection provided for in Article 39 shall be prolonged by one year for each additional target species, provided that, in the case of a variation, the application has been submitted at least three years before the expiration of the protection period laid down in point (a) or (b) of Article 39(1).

2. Where the first marketing authorisation is granted for more than one animal species referred to in point (d) of Article 39(1), or a variation is approved in accordance with Article 67 extending the marketing authorisation to another animal species not referred to in point (a) of Article 39(1), the period of the protection provided for in Article 39 shall be prolonged by four years, provided that, in the case of a variation, the application has been submitted at least three years before the expiration of the protection period laid down in point (d) of Article 39(1).

3. The period of the protection of technical documentation provided for in Article 39 of the first marketing authorisation, prolonged by any additional periods of protection due to any variations or new authorisations belonging to the same marketing authorisation, shall not exceed 18 years.

4. Where an applicant for a marketing authorisation for a veterinary medicinal product or for a variation to the terms of a marketing authorisation submits an application in accordance with Regulation (EC) No 470/2009 for the establishment of a maximum residue limit, together with safety and residues tests and pre-clinical studies and clinical trials during the application procedure, other applicants shall not refer to results of those tests, studies and trials for a period of five years from the granting of the marketing authorisation for which they were carried out. The prohibition on using those results shall not apply, insofar as the other applicants have obtained a letter of access with regard to those tests, studies and trials.

5. If a variation to the terms of the marketing authorisation approved in accordance with Article 67 involves a change to the pharmaceutical form, administration route or dosage, which is assessed by the Agency or the competent authorities referred to in Article 66 to have demonstrated:

(a) a reduction in the antimicrobial or antiparasitic resistance; or

(b) an improvement of the benefit-risk balance of the veterinary medicinal product,

the results of the concerned pre-clinical studies or clinical trials shall benefit from four years protection.

The prohibition on using those results shall not apply, insofar as the other applicants have obtained a letter of access with regard to those studies and trials.