Pharmaceutical product licensing : requirements for Europe / editors, A.C. Cartwright and Brian R. Matthews.
Material type:
TextSeries: Ellis Horwood series in pharmaceutical technologyPublisher: New York : Ellis Horwood, 1991Description: 328 pages ; illustrations : 23 cmContent type: - text
- computer
- online resource
- 9781134994908
- SCI-TECHnetBASE.
- 341.754756151 P 23
- KJE6191 .P43 1991
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
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Main library A6 | Pharmacy ( Pharmaceutical Technology ) | 341.754756151 P (Browse shelf(Opens below)) | Available | 00015918 |
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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
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