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Future System for the Free Movement of Medicial Products in the European Community. Proposal for a Council Regulation (EEC) laying down Community procedures for the authorization and supervision of medicinal products for human and veterinary use and establishing a European Agency for the Evaluation of Medicinal Products. Proposal for a Council Directive amending Directives 65/65/EEC, 75/318/EEC and 75/319/EEC in respect of medicinal products. Proposal for a Council Directive amending Directives 81/851/EEC and 81/852/EEC in respect of veterinary medicinal products. Proposal for a Council Directive repealing Directive 87/22/EEC on the approximation of national measures relating to the placing on the market of high technology medicinal products particularly those derived from biotechnology. COM (90) 283 final, 14 November 1990

Publication Date
Disciplines
  • Communication
  • Medicine

Abstract

.. COMMISSION OF THE EUROPEAN COMMUNITIES COM(9Q) 283 final - SYN 309 to 312 Brussels, 14 November 1990 Future system for the free movement of medicinal products in the European Community Proposal for a COUNCIL REGULATION CEEC) Laying down Community procedures for the authorization and supervision of medicinal products for human and veterinary use and establishing a European Agency for the Evaluation of Medicinal Products Proposal for a COUNCIL DIRECTIVE amending Directives 65/65/EEC, 75/318/EEC and 75/319/EEC in respect of medicinal products ProposaL for a COUNCIL DIRECTIVE amending Directives 81/851/EEC and 31/352/EEC in respect of veterinary medicinal products ProposaL for a COUNCIL DIRECTIVE repealing Directive 87/22/EEC on the approximation of national measures relating to the placing on the market of high technology medicinal products particularly those derived from biotechnology (presented by the Commission) SYN 309 SYN 310 SYN 311 SYN 312 Barbara Rectangle Barbara Sticky Note Completed set by Barbara :z..-3- E X P L A N A T 0 R Y M E M 0 R A N D U M 0 N T H E F U T U R E S Y S T E M F 0 R 0 F T H E M E D F R E E C I N A L M 0 V E M E N T P R 0 D U C T S N T H E E U R 0 P E A N C 0 M M U N I T Y - 4 - EXPLANATORY MEMORANDUM SUMMARY 1. GENERAL CONSIDERATIONS 1.1. State of consultations TABLE OF CONTENTS 1.2. Objectives of the future system 1 .3. The two Community procedures 1.4. The r'elnforced CPMP/CVMP 1.5. The need for an Agency 2. THE AUTHORIZATION OF MEDICINAL PRODUCTS AFTER 1992 2.1. The decentral lzed procedure 2.2. Relationship between the decentral lzed procedure and national authorization procedures 2.3. The central I zed procedure 2.4. The mechanism for binding community decisions 2.5. Transparency of administrative procedures 2.6. Status of marketing authorizations 3. EUROPEAN PHARMACOVIGILANCE 3.1. Pharmacovlgl lance experience in the E

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