CHAPTER IIMARKETING AUTHORISATIONS – GENERAL PROVISIONS AND RULES ON APPLICATIONS

Section 8 Protection of technical documentation

Article 39Periods of the protection of technical documentation

1.

The period of the protection of technical documentation shall be:

(a)

10 years for veterinary medicinal products for cattle, sheep for meat production, pigs, chickens, dogs and cats;

(b)

14 years for antimicrobial veterinary medicinal products for cattle, sheep for meat production, pigs, chickens, dogs and cats containing an antimicrobial active substance which has not been an active substance in a veterinary medicinal product authorised within the Union on the date of the submission of the application;

(c)

18 years for veterinary medicinal products for bees;

(d)

14 years for veterinary medicinal products for animal species other than those referred to in points (a) and (c).

2.

The protection of technical documentation shall apply from the day when the marketing authorisation for the veterinary medicinal product was granted in accordance with Article 5(1).