Explanatory note

These Regulations apply only in relation to medicinal products in respect of which there is a product licence of right. The regulations provide that the issue of advertisements relating to such medicinal products is prohibited unless the relevant product licence includes certain provisions relating to advertisements or the licensing authority have given their consent or they have not specified, within a limited time, that a particular advertisement should not be issued. Regulation 3 makes temporary provisions permitting the issue of advertisements for a limited period where an application to vary the product licence has been made and regulation 4 provides that it shall be an offence to contravene the regulations and imposes penalties.