OpenLegislation

Explanatory note

Original text. Later amendments are not shown.

These Regulations further amend the Medicines (Standard Provisions for Licences and Certificates) Regulations 1971 and add to the Schedules to those regulations. Regulation 3 provides for further standard provisions which may be incorporated in manufacturer's licences. Regulation 4 provides for further standard provisions which may be incorporated in wholesale dealer's licences. To the extent that the regulations apply to proprietary medicinal products they implement certain Community obligations under two Council Directives Nos. 65/65/EEC and 75/319/EEC.