The Resource Pharmaceutical Product Licensing : Requirements for Europe

Pharmaceutical Product Licensing : Requirements for Europe

Label
Pharmaceutical Product Licensing : Requirements for Europe
Title
Pharmaceutical Product Licensing
Title remainder
Requirements for Europe
Creator
Contributor
Subject
Genre
Language
eng
Summary
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
Cataloging source
MiAaPQ
http://library.link/vocab/creatorName
Cartwright, A. C
Dewey number
363.1946094
LC call number
KJE6201.P48 1991
Literary form
non fiction
Nature of contents
dictionaries
http://library.link/vocab/relatedWorkOrContributorName
Matthews, Brian
http://library.link/vocab/subjectName
  • Drugs -- Law and legislation -- European Economic Community countries
  • Pharmaceutical policy -- European Economic Community countries
Label
Pharmaceutical Product Licensing : Requirements for Europe
Link
https://ebookcentral.proquest.com/lib/oulaw/detail.action?docID=242012
Instantiates
Publication
Copyright
Carrier category
online resource
Carrier category code
cr
Carrier MARC source
rdacarrier
Color
multicolored
Content category
text
Content type code
txt
Content type MARC source
rdacontent
Contents
  • Book Cover -- Half-Title -- Title -- Copyright -- Table of Contents -- 1 Introduction and history of pharmaceutical regulation -- 1.1 INTRODUCTION -- 1.2 A BRIEF HISTORY OF PHARMACEUTICAL REGULATION -- 1.2.1 Early history to the nineteenth century -- 1.2.2 The early twentieth century in the UK: beginnings of regulation -- 1.2.3 The early twentieth century in the USA: early regulation -- 1.2.4 Thalidomide -- 1.2.5 Thalidomide: the regulatory aftermath -- 1.2.6 Thalidomide-implications for chirality requirements -- 1.3 THE EUROPEAN COMMUNITY: REGULATION OF PROPRIETARY MEDICINAL PRODUCTS (1965 TO 1987) -- 1.3.1 Introduction -- 1.3.2 Directive 65/65/EEC: definitions and requirements -- 1.3.3 Directive 75/318/EEC: the 'norms and protocols' Directive -- 1.3.4 Directive 75/319/EEC: legal and administrative provisions -- 1.3.5 Decision 75/320/EEC: the Pharmaceutical Committee -- 1.3.6 Directive 78/25/EEC: approved colouring matters -- 1.3.7 Commission Communication of 6 May 1982: parallel importation of medicinal products -- 1.3.8 Directive 83/570/EEC: amending Directive -- 1.3.9 Council Recommendations 83/571/EEC: 'guidelines' -- 1.3.10 Directive 87/19/EEC: the regulatory committee procedure -- 1.3.11 Directive 87/21/EEC: abridged applications for 'copy products' and protection of innovation -- 1.3.12 Directive 87/22/EEC: the high technology/biotechnology procedure -- 1.4 THE EUROPEAN PHARMACOPOEIA -- 1.5 PUBLICATION OF THE COMMUNITY RULES FOR PRODUCT REGISTRATION IN 1989 -- OPEAN MARKET IN PHARMACEUTICAL PRODUCTS ... -- REFERENCES -- 2 The European Community: its structure, institutions, and regulation -- 2.1 INTRODUCTION -- 2.2 THE TREATY OF ROME -- 2.3 THE MEMBER STATES OF THE EUROPEAN ECONOMIC COMMUNITY -- 2.4 THE COMMUNITY INSTITUTIONS -- 2.4.1 The Commission of the European Communities -- 2.4.2 The Council of Ministers
  • 2.4.3 The European Parliament -- 2.4.4 The Economic and Social Committee -- 2.4.5 The European Court of Justice (ECJ) -- 2.5 THE LEGAL INSTRUMENTS OF THE COMMUNITY -- 2.5.1 Regulations -- 2.5.2 Directives -- 2.5.3 Decisions -- 2.5.4 Recommendations -- 2.5.5 Opinions -- 2.5.6 Communications -- 2.6 THE SINGLE EUROPEAN ACT AND THE SINGLE MARKET -- 2.7 THE EUROPEAN FREE TRADE ASSOCIATION (EFTA) -- 2.8 THE NORDIC COUNCIL -- REFERENCE -- 3 New chemical active substance products: quality requirements -- 3.1 INTRODUCTION -- 3.2 SOURCES OF INFORMATION -- 3.3 REQUIREMENTS RELATING TO THE FORMAT OF THE APPLICATION -- 3.4 PART I: THE SUMMARY OF THE DOSSIER -- 3.4.1 Introduction -- 3.4.2 Administrative information -- 3.4.3 Summary of product characteristics -- 3.4.4 Expert Reports -- 3.5 PART II: THE CHEMICAL, PHARMACEUTICAL, AND BIOLOGICAL DOCUMENTATION -- 3.5.1 Introduction -- 3.5.2 Description of analytical methods and analytical validation -- 3.5.3 Part IIA: Composition -- 3.5.4 Part IIB: Method of manufacture of the dosage form -- 3.5.5 Part IIC: Control of starting materials -- 3.5.5.1 New active ingredients -- (a) Identity of the material -- (b) Manufacture of the active ingredient -- (c) Quality control during synthesis -- (d) Development chemistry -- (e) Impurities -- (f) Active ingredient specification -- (g) Batch analyses -- 3.5.5.2 Radiolabelled compounds -- 3.5.5.3 Other ingredients -- 3.5.6 Part IID: Control tests applied at an intermediate stage of the manufacturing process -- 3.5.7 Part IIE: Control tests on the finished product -- 3.5.8 Part IIF: Stability -- 3.5.8.1 Active ingredients -- 3.5.8.2 Finished product -- 3.6 PART V: SPECIAL PARTICULARS -- 3.6.1 PART VA: Dosage form -- 3.6.2 Part VB: Samples -- 3.6.3 Part VC: Manufacturer(s) authorisation(s) -- 3.6.4 Part VD: Marketing authorisation(s) -- 3.7 PRODUCT LABELLING -- REFERENCES
  • 4 New chemical active substance products: preclinical requirements -- 4.1 INTRODUCTION -- 4.2 PHARMACODYNAMICS -- 4.2.1 EC requirements -- 4.2.2 EC guidelines -- 4.3 PHARMACOKINETICS -- 4.3.1 EC requirements -- 4.3.2 EC guidelines -- 4.4 TOXICOLOGY -- 4.4.1 EC requirements -- 4.4.2 EC guidelines -- 4.4.2.1 Single dose toxicity -- 4.4.2.2 Repeat dose toxicity -- 4.5 REPRODUCTIVE TOXICOLOGY -- 4.5.1 EC requirements -- 4.5.2 EC guidelines -- 4.6 MUTAGENICITY STUDIES -- 4.6.1 EC requirements -- 4.6.2 EC guidelines -- 4.7 CARCINOGENICITY STUDIES -- 4.7.1 EC requirements -- 4.7.2 EC guidelines -- 5 New chemical active substance products: clinical requirements -- 5.1 INTRODUCTION -- 5.2 CLINICAL TRIALS -- 5.2.1 National requirements for the regulation of clinical drug trials -- 5.2.2 Good Clinical Practice (GCP) -- 5.2.3 Clinical guidelines -- 5.3 THE CLINICAL DOCUMENTATION -- 5.3.1 Introduction -- 5.3.2 The index -- 5.3.3 Part IVA: Clinical pharmacology -- 5.3.4 Part IVB: Clinical experience -- 5.3.5 Overall summary -- 5.4 THE CLINICAL EXPERT REPORT -- 5.5 CONCLUSION -- 6 Abridged applications -- 6.1 INTRODUCTION -- 6.2 ABRIDGED APPLICATIONS BEFORE JULY 1987 -- 6.2.1 Directive 65/65/EEC -- 6.2.2 Directive 83/570/EEC -- 6.3 DIRECTIVE 87/21/EEC -- 6.3.1 The objectives of the new Directive -- 6.3.2 Protection of pharmaceutical innovation -- 6.3.3 Harmonisation of the rules for products which are copies of established medicinal products -- 6.3.4 Harmonisation of the rules for combination products -- 6.4 REQUIREMENTS FOR INFORMATION ON SECOND APPLICANT PRODUCTS -- 6.5 EVIDENCE OF THE TEN YEAR AUTHORISATION AND MARKETING -- 6.6 ESSENTIAL SIMILARITY -- 6.6.1 The Smith Kline and French judicial review -- 6.6.2 Essential similarity and the active ingredient -- 6.6.3 Essential similarity and the finished product
  • 6.6.4 Essential similarity and the clinical indications -- (8)(a)(ii) OF 65/65/EEC ... -- 6.8 CHEMISTRY AND PHARMACY OF ABRIDGED APPLICATIONS -- 6.8.1 Composition/container/development pharmaceutics -- 6.8.2 Method of preparation -- 6.8.3 Control of starting materials -- 6.8.4 Control tests on intermediate products -- 6.8.5 Control tests on the finished product -- 6.8.6 Stability of the active ingredient and the finished product -- 6.9 PHARMACOTOXICOLOGICAL DATA -- 6.10 CLINICAL DATA -- 6.11 BIOAVAILABILITY AND BIOEQUIVALENCE DATA -- 6.11.1 Verifiability of bioavailability and bioequivalence studies -- REFERENCES -- 7 Drug master files -- 7.1 INTRODUCTION -- 7.2 WHAT IS A DRUG MASTER FILE AND WHEN MAY ONE BE USED? -- 7.2.1 In the United Kingdom -- 7.2.2 In the European Community -- 7.2.3 Comparison with United States Food and Drug Administration DMFs -- 7.3 ASSESSMENT PROCEDURES FOR DMFs IN THE UNITED KINGDOM -- 7.3.1 Introduction -- 7.3.2 Data requirements -- 7.3.3 Experience with DMFs in the United Kingdom -- 7.4 THE EUROPEAN DRUG MASTER FILE PROCEDURE -- 7.4.1 Introduction -- 7.4.2 The European drug master file procedure -- 7.4.3 Related matters -- REFERENCES -- 8 Radiopharmaceutical products -- 8.1 INTRODUCTION -- 8.2 RADIOPHARMACEUTICAL AND RELATED DEFINITIONS -- 8.2.1 UK definitions -- 8.2.1.1 The Medicines Act 1968 -- 8.2.1.2 The Medicines (Radioactive Substances) Order 1978 -- 8.2.2 Relevant European Pharmacopoeia definitions -- 8.2.3 Definitions from Directive 89/343/EEC -- 8.2.4 Definitions from Directive 65/65/EEC -- 8.3 UK CONTROL OF RADIOPHARMACEUTICALS -- 8.3.1 Introduction -- 8.3.2 Basis of data expectations -- 8.3.3 Expert Reports -- 8.3.4 Pharmaceutical data requirements -- 8.3.4.1 Composition -- 8.3.4.2 Development pharmaceutics -- 8.3.4.3 Manufacture -- 8.3.4.4 Impurities -- 8.3.4.5 Other constituents
  • 8.3.4.6 Control tests on the finished product -- 8.3.4.7 Stability data -- 8.3.5 Preclinical data requirements -- 8.3.6 Clinical data requirements -- 8.4 EC INVOLVEMENT IN THE REGULATION OF RADIOPHARMACEUTICAL PRODUCTS -- 8.4.1 Introduction -- 8.4.2 Predicted data requirements for radiopharmaceuticals under EC Directives -- 8.4.2.1 Introduction -- 8.4.2.2 Pharmaceutical, chemical, biological, and microbiological data requirements -- (a) Qualitative particulars -- (b) Quantitative particulars -- (c) Development particulars -- (d) Method of preparation -- (e) Control of starting materials -- (f) Control tests on the finlshed product -- (g) Dosage form-related points -- (h) Stability testing -- 8.4.2.3 Toxicological and pharmacological data requirements -- (a) General -- (b) Subacute toxicity studies -- (c) Mutagenic potential -- (d) Carcinogenic potential -- (e) Reproductive studies -- (f) Pharmacodynamlcs -- (g) Pharmacokinetics -- (h) Radiation dosimetry -- 8.4.2.4 Clinical data requirements -- 8.4.3 Labelling and instruction leaflets -- 8.4.3.1 Introduction -- 8.4.3.2 Directive 89/343/EEC specific requirements -- 8.4.3.3 European Pharmacopoeia requirements -- 8.4.3.4 Instruction leaflet -- 9 Medicated devices -- 9.1 INTRODUCTION -- 9.2 THE DEVELOPMENT OF THE MEDICAL DEVICE DIRECTIVES -- 9.2.1 Introduction -- 9.2.2 The present EC market for medical devices -- 9.2.3 Control of medical devices in the Member States of the EC -- 9.3 IDEAL CHARACTERISTICS FOR A NEW SYSTEM OF CONTROLS FOR MEDICAL DEVICES -- 9.4 'OLD APPROACH' AND 'NEW APPROACH' DIRECTIVES -- 9.4.1 The role of CEN and CENELEC -- 9.4.2 The consultative processes in the EC in the development of a Directive -- 9.4.3 Constituent parts of a 'new approach' Directive -- 9.5 CONTENTS OF THE ACTIVE IMPLANTABLE MEDICAL DEVICE DIRECTIVE (90/385/EEC) -- 89/336/EEC ..
  • 9.5.2 Article 2: Marketing of custom-made and investigational devices
Dimensions
unknown
Extent
1 online resource (329 pages)
Form of item
online
Isbn
9780203984000
Media category
computer
Media MARC source
rdamedia
Media type code
c
Note
Electronic reproduction. Ann Arbor, Michigan : ProQuest Ebook Central, 2019. Available via World Wide Web. Access may be limited to ProQuest Ebook Central affiliated libraries.
Sound
unknown sound
Specific material designation
remote
System control number
  • (MiAaPQ)EBC242012
  • (Au-PeEL)EBL242012
  • (CaPaEBR)ebr10341240
  • (CaONFJC)MIL16863
  • (OCoLC)475959543
Label
Pharmaceutical Product Licensing : Requirements for Europe
Link
https://ebookcentral.proquest.com/lib/oulaw/detail.action?docID=242012
Publication
Copyright
Carrier category
online resource
Carrier category code
cr
Carrier MARC source
rdacarrier
Color
multicolored
Content category
text
Content type code
txt
Content type MARC source
rdacontent
Contents
  • Book Cover -- Half-Title -- Title -- Copyright -- Table of Contents -- 1 Introduction and history of pharmaceutical regulation -- 1.1 INTRODUCTION -- 1.2 A BRIEF HISTORY OF PHARMACEUTICAL REGULATION -- 1.2.1 Early history to the nineteenth century -- 1.2.2 The early twentieth century in the UK: beginnings of regulation -- 1.2.3 The early twentieth century in the USA: early regulation -- 1.2.4 Thalidomide -- 1.2.5 Thalidomide: the regulatory aftermath -- 1.2.6 Thalidomide-implications for chirality requirements -- 1.3 THE EUROPEAN COMMUNITY: REGULATION OF PROPRIETARY MEDICINAL PRODUCTS (1965 TO 1987) -- 1.3.1 Introduction -- 1.3.2 Directive 65/65/EEC: definitions and requirements -- 1.3.3 Directive 75/318/EEC: the 'norms and protocols' Directive -- 1.3.4 Directive 75/319/EEC: legal and administrative provisions -- 1.3.5 Decision 75/320/EEC: the Pharmaceutical Committee -- 1.3.6 Directive 78/25/EEC: approved colouring matters -- 1.3.7 Commission Communication of 6 May 1982: parallel importation of medicinal products -- 1.3.8 Directive 83/570/EEC: amending Directive -- 1.3.9 Council Recommendations 83/571/EEC: 'guidelines' -- 1.3.10 Directive 87/19/EEC: the regulatory committee procedure -- 1.3.11 Directive 87/21/EEC: abridged applications for 'copy products' and protection of innovation -- 1.3.12 Directive 87/22/EEC: the high technology/biotechnology procedure -- 1.4 THE EUROPEAN PHARMACOPOEIA -- 1.5 PUBLICATION OF THE COMMUNITY RULES FOR PRODUCT REGISTRATION IN 1989 -- OPEAN MARKET IN PHARMACEUTICAL PRODUCTS ... -- REFERENCES -- 2 The European Community: its structure, institutions, and regulation -- 2.1 INTRODUCTION -- 2.2 THE TREATY OF ROME -- 2.3 THE MEMBER STATES OF THE EUROPEAN ECONOMIC COMMUNITY -- 2.4 THE COMMUNITY INSTITUTIONS -- 2.4.1 The Commission of the European Communities -- 2.4.2 The Council of Ministers
  • 2.4.3 The European Parliament -- 2.4.4 The Economic and Social Committee -- 2.4.5 The European Court of Justice (ECJ) -- 2.5 THE LEGAL INSTRUMENTS OF THE COMMUNITY -- 2.5.1 Regulations -- 2.5.2 Directives -- 2.5.3 Decisions -- 2.5.4 Recommendations -- 2.5.5 Opinions -- 2.5.6 Communications -- 2.6 THE SINGLE EUROPEAN ACT AND THE SINGLE MARKET -- 2.7 THE EUROPEAN FREE TRADE ASSOCIATION (EFTA) -- 2.8 THE NORDIC COUNCIL -- REFERENCE -- 3 New chemical active substance products: quality requirements -- 3.1 INTRODUCTION -- 3.2 SOURCES OF INFORMATION -- 3.3 REQUIREMENTS RELATING TO THE FORMAT OF THE APPLICATION -- 3.4 PART I: THE SUMMARY OF THE DOSSIER -- 3.4.1 Introduction -- 3.4.2 Administrative information -- 3.4.3 Summary of product characteristics -- 3.4.4 Expert Reports -- 3.5 PART II: THE CHEMICAL, PHARMACEUTICAL, AND BIOLOGICAL DOCUMENTATION -- 3.5.1 Introduction -- 3.5.2 Description of analytical methods and analytical validation -- 3.5.3 Part IIA: Composition -- 3.5.4 Part IIB: Method of manufacture of the dosage form -- 3.5.5 Part IIC: Control of starting materials -- 3.5.5.1 New active ingredients -- (a) Identity of the material -- (b) Manufacture of the active ingredient -- (c) Quality control during synthesis -- (d) Development chemistry -- (e) Impurities -- (f) Active ingredient specification -- (g) Batch analyses -- 3.5.5.2 Radiolabelled compounds -- 3.5.5.3 Other ingredients -- 3.5.6 Part IID: Control tests applied at an intermediate stage of the manufacturing process -- 3.5.7 Part IIE: Control tests on the finished product -- 3.5.8 Part IIF: Stability -- 3.5.8.1 Active ingredients -- 3.5.8.2 Finished product -- 3.6 PART V: SPECIAL PARTICULARS -- 3.6.1 PART VA: Dosage form -- 3.6.2 Part VB: Samples -- 3.6.3 Part VC: Manufacturer(s) authorisation(s) -- 3.6.4 Part VD: Marketing authorisation(s) -- 3.7 PRODUCT LABELLING -- REFERENCES
  • 4 New chemical active substance products: preclinical requirements -- 4.1 INTRODUCTION -- 4.2 PHARMACODYNAMICS -- 4.2.1 EC requirements -- 4.2.2 EC guidelines -- 4.3 PHARMACOKINETICS -- 4.3.1 EC requirements -- 4.3.2 EC guidelines -- 4.4 TOXICOLOGY -- 4.4.1 EC requirements -- 4.4.2 EC guidelines -- 4.4.2.1 Single dose toxicity -- 4.4.2.2 Repeat dose toxicity -- 4.5 REPRODUCTIVE TOXICOLOGY -- 4.5.1 EC requirements -- 4.5.2 EC guidelines -- 4.6 MUTAGENICITY STUDIES -- 4.6.1 EC requirements -- 4.6.2 EC guidelines -- 4.7 CARCINOGENICITY STUDIES -- 4.7.1 EC requirements -- 4.7.2 EC guidelines -- 5 New chemical active substance products: clinical requirements -- 5.1 INTRODUCTION -- 5.2 CLINICAL TRIALS -- 5.2.1 National requirements for the regulation of clinical drug trials -- 5.2.2 Good Clinical Practice (GCP) -- 5.2.3 Clinical guidelines -- 5.3 THE CLINICAL DOCUMENTATION -- 5.3.1 Introduction -- 5.3.2 The index -- 5.3.3 Part IVA: Clinical pharmacology -- 5.3.4 Part IVB: Clinical experience -- 5.3.5 Overall summary -- 5.4 THE CLINICAL EXPERT REPORT -- 5.5 CONCLUSION -- 6 Abridged applications -- 6.1 INTRODUCTION -- 6.2 ABRIDGED APPLICATIONS BEFORE JULY 1987 -- 6.2.1 Directive 65/65/EEC -- 6.2.2 Directive 83/570/EEC -- 6.3 DIRECTIVE 87/21/EEC -- 6.3.1 The objectives of the new Directive -- 6.3.2 Protection of pharmaceutical innovation -- 6.3.3 Harmonisation of the rules for products which are copies of established medicinal products -- 6.3.4 Harmonisation of the rules for combination products -- 6.4 REQUIREMENTS FOR INFORMATION ON SECOND APPLICANT PRODUCTS -- 6.5 EVIDENCE OF THE TEN YEAR AUTHORISATION AND MARKETING -- 6.6 ESSENTIAL SIMILARITY -- 6.6.1 The Smith Kline and French judicial review -- 6.6.2 Essential similarity and the active ingredient -- 6.6.3 Essential similarity and the finished product
  • 6.6.4 Essential similarity and the clinical indications -- (8)(a)(ii) OF 65/65/EEC ... -- 6.8 CHEMISTRY AND PHARMACY OF ABRIDGED APPLICATIONS -- 6.8.1 Composition/container/development pharmaceutics -- 6.8.2 Method of preparation -- 6.8.3 Control of starting materials -- 6.8.4 Control tests on intermediate products -- 6.8.5 Control tests on the finished product -- 6.8.6 Stability of the active ingredient and the finished product -- 6.9 PHARMACOTOXICOLOGICAL DATA -- 6.10 CLINICAL DATA -- 6.11 BIOAVAILABILITY AND BIOEQUIVALENCE DATA -- 6.11.1 Verifiability of bioavailability and bioequivalence studies -- REFERENCES -- 7 Drug master files -- 7.1 INTRODUCTION -- 7.2 WHAT IS A DRUG MASTER FILE AND WHEN MAY ONE BE USED? -- 7.2.1 In the United Kingdom -- 7.2.2 In the European Community -- 7.2.3 Comparison with United States Food and Drug Administration DMFs -- 7.3 ASSESSMENT PROCEDURES FOR DMFs IN THE UNITED KINGDOM -- 7.3.1 Introduction -- 7.3.2 Data requirements -- 7.3.3 Experience with DMFs in the United Kingdom -- 7.4 THE EUROPEAN DRUG MASTER FILE PROCEDURE -- 7.4.1 Introduction -- 7.4.2 The European drug master file procedure -- 7.4.3 Related matters -- REFERENCES -- 8 Radiopharmaceutical products -- 8.1 INTRODUCTION -- 8.2 RADIOPHARMACEUTICAL AND RELATED DEFINITIONS -- 8.2.1 UK definitions -- 8.2.1.1 The Medicines Act 1968 -- 8.2.1.2 The Medicines (Radioactive Substances) Order 1978 -- 8.2.2 Relevant European Pharmacopoeia definitions -- 8.2.3 Definitions from Directive 89/343/EEC -- 8.2.4 Definitions from Directive 65/65/EEC -- 8.3 UK CONTROL OF RADIOPHARMACEUTICALS -- 8.3.1 Introduction -- 8.3.2 Basis of data expectations -- 8.3.3 Expert Reports -- 8.3.4 Pharmaceutical data requirements -- 8.3.4.1 Composition -- 8.3.4.2 Development pharmaceutics -- 8.3.4.3 Manufacture -- 8.3.4.4 Impurities -- 8.3.4.5 Other constituents
  • 8.3.4.6 Control tests on the finished product -- 8.3.4.7 Stability data -- 8.3.5 Preclinical data requirements -- 8.3.6 Clinical data requirements -- 8.4 EC INVOLVEMENT IN THE REGULATION OF RADIOPHARMACEUTICAL PRODUCTS -- 8.4.1 Introduction -- 8.4.2 Predicted data requirements for radiopharmaceuticals under EC Directives -- 8.4.2.1 Introduction -- 8.4.2.2 Pharmaceutical, chemical, biological, and microbiological data requirements -- (a) Qualitative particulars -- (b) Quantitative particulars -- (c) Development particulars -- (d) Method of preparation -- (e) Control of starting materials -- (f) Control tests on the finlshed product -- (g) Dosage form-related points -- (h) Stability testing -- 8.4.2.3 Toxicological and pharmacological data requirements -- (a) General -- (b) Subacute toxicity studies -- (c) Mutagenic potential -- (d) Carcinogenic potential -- (e) Reproductive studies -- (f) Pharmacodynamlcs -- (g) Pharmacokinetics -- (h) Radiation dosimetry -- 8.4.2.4 Clinical data requirements -- 8.4.3 Labelling and instruction leaflets -- 8.4.3.1 Introduction -- 8.4.3.2 Directive 89/343/EEC specific requirements -- 8.4.3.3 European Pharmacopoeia requirements -- 8.4.3.4 Instruction leaflet -- 9 Medicated devices -- 9.1 INTRODUCTION -- 9.2 THE DEVELOPMENT OF THE MEDICAL DEVICE DIRECTIVES -- 9.2.1 Introduction -- 9.2.2 The present EC market for medical devices -- 9.2.3 Control of medical devices in the Member States of the EC -- 9.3 IDEAL CHARACTERISTICS FOR A NEW SYSTEM OF CONTROLS FOR MEDICAL DEVICES -- 9.4 'OLD APPROACH' AND 'NEW APPROACH' DIRECTIVES -- 9.4.1 The role of CEN and CENELEC -- 9.4.2 The consultative processes in the EC in the development of a Directive -- 9.4.3 Constituent parts of a 'new approach' Directive -- 9.5 CONTENTS OF THE ACTIVE IMPLANTABLE MEDICAL DEVICE DIRECTIVE (90/385/EEC) -- 89/336/EEC ..
  • 9.5.2 Article 2: Marketing of custom-made and investigational devices
Dimensions
unknown
Extent
1 online resource (329 pages)
Form of item
online
Isbn
9780203984000
Media category
computer
Media MARC source
rdamedia
Media type code
c
Note
Electronic reproduction. Ann Arbor, Michigan : ProQuest Ebook Central, 2019. Available via World Wide Web. Access may be limited to ProQuest Ebook Central affiliated libraries.
Sound
unknown sound
Specific material designation
remote
System control number
  • (MiAaPQ)EBC242012
  • (Au-PeEL)EBL242012
  • (CaPaEBR)ebr10341240
  • (CaONFJC)MIL16863
  • (OCoLC)475959543

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