Description
Provides a systematic account of the major technical, administrative and legal requirements for registering a product in any of the national markets within the EEC, using the existing procedures, with guidance as to how these procedures are likely to change after 1992.
Table of Contents
PREFACE, 1. INTRODUCTION AND HISTORY OF PHARMACEUTICAL REGULATION, 2. THE EUROPEAN COMMUNITY: ITS STRUCTURE, INSTITUTIONS, AND REGULATION, 3. NEW CHEMICAL ACTIVE SUBSTANCE PRODUCTS: QUALITY REQUIREMENTS, 4. NEW CHEMICAL ACTIVE SUBST ANCE PRODUCTS: PRECLINICAL REQUIREMENTS, 5. NEW CHEMICAL ACTIVE SUBSTANCE PRODUCTS: CLINICAL REQUIREMENTS, 6. ABRIDGED APPLICATIONS, 7. DRUG MASTER FILES, 8. RADIOPHARMACEUTICAL PRODUCTS, 9. MEDICATED DEVICES, 10. CONTACT LENS PRODUCTS AND INTRAUTERINE CONTRACEPTIVE DEVICES, 11. EXPERTS AND EXPERT REPORTS IN MARKETING AUTHORISATION APPLICATIONS, 12. DEFECTS IN APPLICATIONS -AN ANALYSIS, 13. CPMP AND THE PHARMACEUTICAL COMMITTEE, 14. CPMP MULTISTATE PROCEDURE, 15. THE CONCERTATION (HIGH TECHNOLOGYIBIOTECHNOLOGY) PROCEDURE, 16. REGULATORY STRATEGY: THE EC, EFTA, THE PER SCHEME, 17. THE UNITED KINGDOM'S SYSTEM FOR LICENSING PHARMACEUTICAL PRODUCTS, 18. THE OTHER NATIONAL AUTHORITIES IN THE EC, 19. EEC GUIDELINES -QUALITY, SAFETY, EFFICACY, AND BIOTECHNOLOGY, 20. THE NEW GENERAL DIRECTIVE, IMMUNOLOGICALS, ETC. DIRECTIVES, 21. THE SINGLE MARKET AFTER 1992: NEW DIRECTIONS, APPENDIX: ABBREVIATIONS AND ACRONYMS, INDEX
