ABSTRACT

Volume 1 Pharmaceutical legislation: Medicinal products for human use Volume 2 Notice to applicants: Medicinal products for human use Volume 3 Guidelines: Medicinal products for human use Volume 4 Good manufacturing practices: Medicinal products for human and

veterinary use Volume 5 Pharmaceutical legislation: Veterinary medicinal products Volume 6 Notice to applicants: Veterinary medicinal products Volume 7 Guidelines: Veterinary medicinal products Volume 8 Maximum residue limits: Veterinary medicinal products Volume 9 Pharmacovigilance: Medicinal products for human and veterinary use

FOREWORD

The Pharmaceutical Industry of the European Community maintains high standards of Quality Assurance in the development, manufacture and control of medicinal products. A system of Marketing Authorisations ensures that all medicinal products are assessed by a Competent Authority to ensure compliance with contemporary requirements of safety, quality and efficacy. A system of Manufacturing Authorisations ensures that all products authorised on the European market are manufactured only by authorised manufacturers, whose activities are regularly inspected by the Competent Authorities. Manufacturing

Authorisations are required by all pharmaceutical manufacturers in the European Community whether the products are sold within or outside of the Community.