Paragraph 9 Administration under an animal test certificateE1

A medicinal product may be administered in accordance with an animal test certificate granted for F1clinical trials by the Secretary of State.

An application for an animal test certificate may be refused if this is necessary for the protection of animal or public health or the environment, and the animal test certificate may be varied, suspended or revoked in the same way as a marketing authorisation.

The holder of an animal test certificate may not supply a product for administration that is not within the terms of the animal test certificate.

The holder of an animal test certificate test who becomes aware of any F2adverse event following the administration of a product under an animal test certificate must report the reaction to the Secretary of State within F330 days of learning of it.