SCHEDULE 1Marketing authorisations

PART 8Pharmacovigilance

Release of information by the marketing authorisation holder60

1

A marketing authorisation holder must not communicate information relating to pharmacovigilance concerns to the general public in relation to its authorised veterinary medicinal product without giving prior or simultaneous notification to the Secretary of State.

2

The marketing authorisation holder must ensure that such information is presented objectively and is not misleading.

3

It is an offence to fail to comply with this paragraph.