Regulation 24 Standard provisions of licences

The standard provisions set out in Schedule 4 may be incorporated by the licensing authority in a licence under this Part granted on or after the date on which these Regulations come into force.

The standard provisions may be incorporated in a licence with or without modifications and either generally or in relation to medicinal products of a particular class.

In Schedule 4, in relation to a licence holder in Great Britain, references to the principles and guidelines set out in the Good Manufacturing Practice Directive are to those principles and guidelines as they apply under or by virtue of regulation B17.