Paragraph 37 Compulsory variationI1

If the Secretary of State decides, in order to protect human or animal heath or the environment, that a variation to a marketing authorisation is necessary, he shall notify the marketing authorisation holder in writing of the required variation, together with his reasons.

In the notification he may specify a time limit within which the marketing authorisation holder must apply for the variation.

If the marketing authorisation holder fails to apply within that time limit the Secretary of State may suspend or revoke the marketing authorisation.