SCHEDULE 1Marketing authorisations F1in Great BritainF2in Northern Ireland

Annotations:
Amendments (Textual)

PART 3Grant of a marketing authorisation

Supply of information28

1

A marketing authorisation holder must immediately inform the Secretary of State on receipt of any new information that might adversely affect the risk-benefit balance of the veterinary medicinal product.

2

The holder must immediately inform the Secretary of State of any prohibition or restriction imposed by the competent authorities of any country in which the veterinary medicinal product is authorised.

3

The Secretary of State may at any time require the marketing authorisation holder to provide data relating to the risk-benefit balance.