Regulation 73 New paragraphs 60A and 60B

After paragraph 60 insert—

“Pharmacovigilance inspections by Secretary of State

60A.

(1)

The Secretary of State must, from time to time, inspect the pharmacovigilance systems of marketing authorisation holders for the purpose of verifying compliance with the provisions of this Schedule in relation to pharmacovigilance.

(2)

The frequency of inspections under sub-paragraph (1) must be based on the risks associated with each marketing authorisation holder’s history and the nature of the products included in their pharmacovigilance system.

(3)

Within 90 days after an inspection, the Secretary of State must issue an inspection report to the holder of the marketing authorisation if the inspection established compliance with best practice in good veterinary pharmacovigilance practice.

Powers of Secretary of State in relation to signal management process

60B.

The Secretary of State may decide to perform a targeted signal management process for a given veterinary medicinal product or a group of veterinary medicinal products.”.