The single market for pharmaceuticals:
Gespeichert in:
| 1. Verfasser: | |
|---|---|
| Format: | Buch |
| Sprache: | English |
| Veröffentlicht: |
London u.a.
Butterworths
1994
|
| Schriftenreihe: | Current EC legal development series
|
| Schlagworte: | |
| Online-Zugang: | Inhaltsverzeichnis |
| Beschreibung: | XXXII, 434 S. |
| ISBN: | 0406005567 |
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| adam_text | THE SINGLE MARKET FOR PHARMACEUTICALS RHODRI THOMPSON, M.A., B.PHIL.
BARRISTER, LONDON AND BRUSSELS BUTTERWORTHS LONDON, DUBLIN, EDINBURGH
1994 TABLE OF CONTENTS TABLES XI PART I: THE SCOPE OF COMMUNITY
PHARMACEUTICAL REGULATION 1 CHAPTER 1 : INTRODUCTION 3 1.1 SCOPE OF THIS
WORK 3 1.2 HARMONISATION OF THE PHARMACEUTICAL MARKET 4 1.3 THE
STRUCTURE OF THIS WORK 6 1.4 TOPICS NOT COVERED IN THIS WORK 8 1.4.1 THE
SUPPLEMENTARY PROTECTION CERTIFICATE 8 1.4.2 TRANSPARENCY IN PRICING AND
REIMBURSEMENT UNDER NATIONAL HEALTH 9 1.4.3 GENERIC COMPETITORS AND
PARALLEL IMPORTERS 11 1.4.4 OTHER ISSUES 13 1.5 MATERIALS 1 4 CHAPTER 2
: WHAT IS A MEDICINAL PRODUCT ? 17 2.1 THE CONCEPT OF MEDICINAL
PRODUCT IN COMMUNITY LAW 17 2.2 DIFFICULTIES OF INTERPRETATION 18 2.3
THE STRUCTURE OF ARTICLE 1 (2) OF DIRECTIVE (EEC) 65/65 19 2.3.1 THE TWO
DEFINITIONS 19 2.3.2 THE PRIORITY OF THE DEFINITION OF MEDICINAL
PRODUCTS OVER OTHER COMMUNITY DEFINITIONS 21 2.4 THE PRESENTATION
CRITERION 21 2.4.1 SUBSTANCE 21 2.4.2 PRESENTATION 22 2.4.3 TREATMENT OR
PREVENTION OF DISEASE 24 2.4.4 DISEASE 25 2.5 THE FUNCTION CRITERION 27
2.5.1 THE STATUS OF THE DEFINITION 27 2.5.2 SUBSTANCE 28 2.5.3
ADMINISTRATION 28 2.5.4 MEDICAL DIAGNOSIS 29 2.5.5 RESTORATION,
CORRECTION OR MODIFICATION OF PHYSIOLOGICAL FUNCTIONS 30 2.5.6
PRESENTATION UNDER THE SECOND DEFINITION 33 2.6 THE ROLE OF THE MEMBER
STATES 34 2.6.1 NATIONAL DEFINITIONS OF MEDICINAL PRODUCTS BEFORE 1
JANUARY 1993 34 2.6.2 THE MEMBER STATES MARGIN OF APPRECIATION AFTER 1
JANUARY 1993 35 2.6.3 THE ROLE OF NATIONAL COURTS 39 2.7 PRODUCTS
BORDERING ON MEDICINAL PRODUCTS 40 2.7.1 FOODSTUFFS 40 2.7.2 COSMETICS
41 2.7.3 HOUSEHOLD GOODS 43 2.7.4 MEDICAL DEVICES 43 2.7.5 EXCIPIENTS 45
PART II: MARKETING AUTHORISATION - THE CURRENT SYSTEM 47 CHAPTER 3 :
DIRECTIVE (EEC) 65/65 - THE ORIGINAL FRAMEWORK DIRECTIVE 49 3.1 THE
ORIGINAL PRINCIPLES: THE RECITALS AND THE STRUCTURE OF THE DIRECTIVE 49
3.2 THE FUNDAMENTAL REQUIREMENTS: ARTICLES 3, 5 AND 21 50 3.3 PLACING
MEDICINAL PRODUCTS ON THE MARKET: CHAPTER I, ARTICLES 1 AND 2 52 3.4
OBTAINING MARKETING AUTHORISATION : ARTICLE 4 53 3.4.1 THE FRAMEWORK
REQUIREMENTS FOR AUTHORISATION 54 3.4.2 ABRIDGED APPLICATIONS 55 3.4.3
THE SUMMARY OF PRODUCT CHARACTERISTICS 58 3.5 CONTRACEPTIVE PRODUCTS:
ARTICLE 6 59 3.6 ADMINISTRATIVE DETAILS : ARTICLES 7 TO 10 AND 12 59 3.7
THE SUSPENSION AND REVOCATION OF A MARKETING AUTHORISATION : CHAPTER
III, ARTICLE 11 61 3.8 LABELLING: ARTICLES 13 TO 20 61 3.9 PRODUCTS
ALREADY AUTHORISED : ARTICLE 24 61 CHAPTER 4 : COUNCIL DIRECTIVE (EEC)
75/318 - THE SUBSTANCE OF THE MARKETING AUTHORISATION PROCESS 63 4.1 THE
PURPOSE OF THE DIRECTIVE : THE RECITALS 63 4.2 THE MAIN TEXT OF THE
DIRECTIVE 64 4.3 THE ANNEX TO THE DIRECTIVE 66 CHAPTER 5 : COUNCIL
DIRECTIVE (EEC) 75/319 - ADMINISTRATIVE REQUIREMENTS AND THE
ESTABLISHMENT OF THE COMMITTEE FOR PROPRIETARY MEDICINAL PRODUCTS - THE
MULTI-STATE PROCEDURE 67 5.1 THE SCOPE AND STRUCTURE OF THE DIRECTIVE
: THE RECITALS 67 5.2 FURTHER REQUIREMENTS IN RESPECT OF THE APPLICATION
FOR MARKETING AUTHORISATION : CHAPTER I, ARTICLES 1 TO 3 69 5.3 GUIDANCE
TO THE MEMBER STATES IN EXAMINING APPLICATIONS FOR MARKETING
AUTHORISATION : CHAPTER II, ARTICLES 4 TO 7 70 5.4 THE COMMITTEE FOR
PROPRIETARY MEDICINAL PRODUCTS: CHAPTER III, ARTICLES 8 TO 15 71 5.4.1
INITIATING THE MULTI-STATE PROCEDURE : ARTICLES 9 AND 10 72 5.4.2 OTHER
MECHANISMS, FOR CONSULTATION OF THE CPMP : ARTICLES 11 AND 12 74 5.4.3
ASSESSMENT REPORTS: ARTICLE 13 75 5.4.4 PROCEDURE: ARTICLE 14 76 5.4.5
REVIEW OF THE MULTI-STATE PROCEDURE 78 5.5 MISCELLANEOUS PROVISIONS :
CHAPTER VI, ARTICLES 30 TO 40 78 CHAPTER 6 : DIRECTIVE (EEC) 87/22 -
HIGH TECHNOLOGY PRODUCTS AND THE CONCERTATION PROCEDURE 81 6.1 THE
PATH TOWARDS CENTRALISATION 81 6.2 INDUSTRIAL POLICY AND GUARANTEED
STANDARDS : THE RECITALS 82 6.3 THE SCOPE OF THE DIRECTIVE : ARTICLES 1
AND 2 AND THE ANNEX 83 6.4 PROCEDURAL REQUIREMENTS : ARTICLES 3 AND 4 86
6.5 MISCELLANEOUS PROVISIONS: ARTICLE 5 87 6.6 CONCLUSION 88 PART III:
MARKETING AUTHORISATION - THE FUTURE SYSTEM 89 CHAPTER 7 : REGULATION
(EEC) 2309/93 - THE CENTRALISED PROCEDURE AND THE EUROPEAN AGENCY FOR
THE EVALUATION OF MEDICINAL PRODUCTS 91 7.1 THE PURPOSE AND STRUCTURE OF
THE REGULATION : THE RECITALS 91 7.2 DEFINITIONS AND SCOPE : TITLE I,
ARTICLES 1 TO 4 94 7.3 THE GRANTING OF A COMMUNITY AUTHORISATION : TITLE
III, CHAPTER 1 97 7.3.1 THE SUBSTANCE OF THE AUTHORISATION PROCESS :
ARTICLES 6 TO 8 97 7.3.2 CPMP PROCEDURES: ARTICLE 9 102 7.3.3 BINDING
COMMUNITY DECISIONS : ARTICLE 10 103 7.3.4 THE CRITERIA FOR
AUTHORISATION : ARTICLE 11 105 7.3.5 ADMINISTRATIVE DETAILS: ARTICLES 12
TO 14 106 7.4 SUPERVISION AND PHARMACOVIGI LANCE : TITLE III, CHAPTERS 2
AND 3 109 7.5 THE EUROPEAN AGENCY FOR THE EVALUATION OF MEDICINAL
PRODUCTS: TITLE IV, ARTICLES 49 TO 66 110 7.5.1 THE TASKS OF THE AGENCY
: TITLE IV, CHAPTER 1 110 7.5.2 FINANCIAL PROVISIONS FOR THE AGENCY :
TITLE IV, CHAPTER 2 116 7.5.3 GENERAL PROVISIONS GOVERNING THE AGENCY :
TITLE IV, CHAPTER 3 118 7.6 GENERAL AND FINAL PROVISIONS : TITLE IV,
ARTICLES 67 TO 74 119 CHAPTER 8 : DIRECTIVES (EEC) 93/39 AND 93/41 - THE
DECENTRALISED PROCEDURE AND THE END OF THE MULTI-STATE AND
CONCERTATION PROCEDURES 1 2 3 8.1 THE PURPOSE AND SCOPE OF THE NEW
REGIME : THE RECITALS TO DIRECTIVE (EEC) 93/39 123 8.2 AMENDMENTS TO
DIRECTIVE (EEC) 65/65 124 8.3 AMENDMENTS TO DIRECTIVE (EEC) 75/318 128
8.4 AMENDMENTS TO DIRECTIVE (EEC) 75/319 : THE NEW DECENTRALISED 128
8.4.1 ACTIVATING THE DECENTRALISED PROCEDURE : ARTICLES 9 AND 10 129
8.4.2 OTHER MECHANISMS FOR CONSULTATION OF THE CPMP : ARTICLES 11 AND 12
133 8.4.3 THE CPMP S PROCEDURES : ARTICLE 13 133 8.4.4 BINDING COMMUNITY
DECISIONS : ARTICLE 14 136 8.4.5 VARIATIONS AND REVIEW OF THE
DECENTRALISED PROCEDURE : ARTICLES 15 TO 15C 136 8.5 IMPLEMENTATION OF
DIRECTIVE (EEC) 93/39 : ARTICLE 4 138 8.6 THE REPEAL OF DIRECTIVE (EEC)
87/22 : DIRECTIVE (EEC) 93/41 139 CHAPTER 9 : DIRECTIVE (EEC) 92/73 - AN
AUTHORISATION REGIME FOR HOMEOPATHIC MEDICINAL PRODUCTS 141 9.1 THE
PURPOSE OF THE DIRECTIVE : THE RECITALS 141 9.2 THE SCOPE OF THE
DIRECTIVE : CHAPTER 1 143 9.3 MANUFACTURE, CONTROL AND INSPECTION :
CHAPTER 2, ARTICLES 3 TO 5 144 9.4 PLACING THE PRODUCT ON THE MARKET:
CHAPTER 3, ARTICLES 6 TO 9 145 9.5 FINAL PROVISIONS : CHAPTER IV,
ARTICLES 10 AND 11 151 PART IV : CONTINUING SUPERVISION OF AUTHORISED
PRODUCTS 153 CHAPTER 10 : THE AUTHORISATION OF THE MANUFACTURE OF
MEDICINAL PRODUCTS 1 55 10.1 THE AUTHORISATION REQUIREMENT: CHAPTER IV
OF DIRECTIVE (EEC) 75/319, ARTICLES 16 TO 20 155 10.2 THE NEED FOR
QUALIFIED PERSONNEL : CHAPTER IV OF DIRECTIVE (EEC) 75/319, ARTICLES 21
TO 25 159 10.3 SUPERVISION OF MANUFACTURE : CHAPTER V OF DIRECTIVE (EEC)
75/319 162 10.4 INFORMATION EXCHANGE : CHAPTERS VI AND VII OF DIRECTIVE
(EEC) 75/319 164 10.5 PRINCIPLES OF GOOD MANUFACTURING PRACTICE :
DIRECTIVE (EEC) 91/356 165 10.6 MANUFACTURE OF PRODUCTS AUTHORISED AT
THE COMMUNITY LEVEL : REGULATION (EEC) 2309/93 167 CHAPTER 11 : THE
SUPERVISION OF AUTHORISED PRODUCTS 171 11.1 THE ORIGINAL RULES : CHAPTER
III OF DIRECTIVE (EEC) 65/65 171 11.2 CONSULTATION OF THE CPMP AT THE
OPTION OF THE MEMBER STATES: ARTICLES 11 AND 12 OF DIRECTIVE (EEC)
75/319 173 11.3 POST-AUTHORISATION SUPERVISION : CHAPTERS V AND VI OF
DIRECTIVE (EEC) 75/319 173 11.4 COMPULSORY CONSULTATION OF THE CPMP :
ARTICLE 2(4) AND ARTICLE 4(2) OF DIRECTIVE (EEC) 87/22 176 11.5
SUPERVISION OF COMMUNITY AUTHORISED PRODUCTS : ARTICLES 15 AND 18,
CHAPTER 2, TITLE II OF REGULATION (EEC) 2309/93 1.77 11.6 AMENDMENTS TO
DIRECTIVES (EEC) 65/65 AND 75/319 IN RESPECT OF SUPERVISION : DIRECTIVE
(EEC) 93/39 181 CHAPTER 12 : PHARMACOVIGILANCE 183 12.1 INTRODUCTION :
OLD WINE IN NEW BOTTLES 183 12.2 THE GENERAL SCHEME OF PHARMACOVIGILANCE
BY THE MEMBER STATES: CHAPTER VA OF DIRECTIVE (EEC) 75/319 183 12.3
PHARMACOVIGILANCE FOR CENTRALLY AUTHORISED PRODUCTS: TITLE II, CHAPTER 3
OF REGULATION (EEC) 2309/93 188 PART V : MARKETING OF AUTHORISED
PRODUCTS -THE RATIONAL USE PACKAGE 193 CHAPTER 13 : DIRECTIVE (EEC)
92/25 - THE WHOLESALE DISTRIBUTION OF AUTHORISED PRODUCTS 195 13.1 THE
SCHEME OF THE DIRECTIVE: THE RECITALS 195 13.2 SCOPE AND DEFINITIONS :
ARTICLE 1 196 13.3 AUTHORISATION AS A WHOLESALE DISTRIBUTOR: ARTICLES 2
AND 3 196 13.4 PROCEDURES AND CRITERIA FOR AUTHORISATION : ARTICLES 4 TO
12 198 CHAPTER 14 : DIRECTIVE (EEC) 92/26 - THE CLASSIFICATION OF
AUTHORISED PRODUCTS 203 14.1 THE NEED FOR THE DIRECTIVE : THE RECITALS
203 14.2 SCOPE AND DEFINITIONS: ARTICLE 1 205 14.3 CLASSIFICATION AND
CLASSIFICATION CRITERIA : ARTICLES 2 TO 4 205 14.4 ADMINISTRATIVE
PROVISIONS : ARTICLES 5 TO 8 208 CHAPTER 15 : DIRECTIVE (EEC) 92/27 -
LABELLING AND PACKAGE LEAFLETS FOR AUTHORISED PRODUCTS 209 15.1
INTRODUCTION: THE RECITALS 209 15.2 SCOPE AND DEFINITIONS: CHAPTER I,
ARTICLE 1 210 15.3 LABELLING : CHAPTER II, ARTICLES 2 TO 5 214 15.4
PACKAGE LEAFLETS : CHAPTER III, ARTICLES 6 TO 9 219 15.5 GENERAL AND
FINAL PROVISIONS : CHAPTER IV, ARTICLES 10 TO 15 224 CHAPTER 16 :
DIRECTIVE (EEC) 92/28 - THE ADVERTISING OF AUTHORISED PRODUCTS 229 16.1
INTRODUCTION: THE RECITALS 229 16.2 SCOPE, DEFINITIONS AND GENERAL
PRINCIPLES: CHAPTER I, ARTICLES 1 AND 2 232 16.3 ADVERTISING TO THE
GENERAL PUBLIC : CHAPTER II, ARTICLES 3 TO 5 235 16.4 ADVERTISING TO
HEALTH PROFESSIONALS 240 16.5 MONITORING OF ADVERTISING : CHAPTER IV,
ARTICLES 12 TO 16 243 APPENDICES 247 APPENDIX 1 : COUNCIL DIRECTIVE
(EEC) 65/65 (OJ NO22 9.2.65 P369/65) 249 APPENDIX 2 : COUNCIL DIRECTIVE
(EEC) 75/318 (OJ L147 9.6.75 P1) 261 APPENDIX 3 : COUNCIL DIRECTIVE
(EEC) 75/319 (OJ LI 47 9.6.75 P13) 289 APPENDIX 4 : COUNCIL DIRECTIVE
(EEC) 87/22 (OJ L15 17.1.87 P38) 315 APPENDIX 5 : COUNCIL REGULATION
(EEC) 2309/93 (OJ L214 24.8.93 P1) 321 APPENDIX 6 : COUNCIL DIRECTIVE
(EEC) 93/39 (OJ L214 24.8.93 P22) 353 APPENDIX 7 : COUNCIL DIRECTIVE
(EEC) 93/41 (OJ L214 24.8.93 P40) 355 APPENDIX 8 : COUNCIL DIRECTIVE
(EEC) 92/73 (OJ L297 13.10.92 P8) 357 APPENDIX 9 : COMMISSION DIRECTIVE
(EEC) (OJ L193 17.7.91 P30) 363 APPENDIX 10 : COUNCIL DIRECTIVE (EEC)
92/25 (OJ L113 30.4.92 P1) 369 APPENDIX 11 : COUNCIL DIRECTIVE (EEC)
92/26 (OJ L113 30.4.92 P5) 375 APPENDIX 12 : COUNCIL DIRECTIVE (EEC)
92/27 (OJ L113 30.4.92 P8) 379 APPENDIX 13 : COUNCIL DIRECTIVE (EEC)
92/28 (OJ L113 30.4.92 P13) 387 APPENDIX 14 : COUNCIL REGULATION (EEC)
1768/92 (OJ L182 2.7.92 P1) 397 APPENDIX 15 : COUNCIL DIRECTIVE (EEC)
89/105 (OJ L40 11.2.89 P8) 405 APPENDIX 16 : COMMISSION COMMUNICATION ON
PARALLEL IMPORTS OF PROPRIETARY MEDICINAL PRODUCTS(OJ C115 6.5.82 P5)
413 APPENDIX 17 : COMMISSION COMMUNICATION ON PRICE CONTROL AND
REIMBURSEMENT OF MEDICINAL PRODUCTS (OJ C310 4.12.86 P7) 419 INDEX 427
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| indexdate | 2024-07-09T17:43:30Z |
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| series2 | Current EC legal development series |
| spelling | Thompson, Rhodri Verfasser aut The single market for pharmaceuticals Rhodri Thompson London u.a. Butterworths 1994 XXXII, 434 S. txt rdacontent n rdamedia nc rdacarrier Current EC legal development series European Community Europäische Gemeinschaften (DE-588)35439-9 gnd rswk-swf Europees recht gtt Farmaceutische industrie gtt Harmonisatie gtt Médicaments - Droit européen ram Pharmacie - Droit européen ram Europarecht Recht Drugs Law and legislation European Union countries Pharmaceutical industry European Union countries Arzneimittelhandel (DE-588)4143178-9 gnd rswk-swf Binnenmarkt (DE-588)4145576-9 gnd rswk-swf Europäische Union. Mitgliedsstaaten Arzneimittelhandel (DE-588)4143178-9 s Europäische Gemeinschaften (DE-588)35439-9 b Binnenmarkt (DE-588)4145576-9 s DE-604 GBV Datenaustausch application/pdf http://bvbr.bib-bvb.de:8991/F?func=service&doc_library=BVB01&local_base=BVB01&doc_number=006581943&sequence=000001&line_number=0001&func_code=DB_RECORDS&service_type=MEDIA Inhaltsverzeichnis |
| spellingShingle | Thompson, Rhodri The single market for pharmaceuticals European Community Europäische Gemeinschaften (DE-588)35439-9 gnd Europees recht gtt Farmaceutische industrie gtt Harmonisatie gtt Médicaments - Droit européen ram Pharmacie - Droit européen ram Europarecht Recht Drugs Law and legislation European Union countries Pharmaceutical industry European Union countries Arzneimittelhandel (DE-588)4143178-9 gnd Binnenmarkt (DE-588)4145576-9 gnd |
| subject_GND | (DE-588)35439-9 (DE-588)4143178-9 (DE-588)4145576-9 |
| title | The single market for pharmaceuticals |
| title_auth | The single market for pharmaceuticals |
| title_exact_search | The single market for pharmaceuticals |
| title_full | The single market for pharmaceuticals Rhodri Thompson |
| title_fullStr | The single market for pharmaceuticals Rhodri Thompson |
| title_full_unstemmed | The single market for pharmaceuticals Rhodri Thompson |
| title_short | The single market for pharmaceuticals |
| title_sort | the single market for pharmaceuticals |
| topic | European Community Europäische Gemeinschaften (DE-588)35439-9 gnd Europees recht gtt Farmaceutische industrie gtt Harmonisatie gtt Médicaments - Droit européen ram Pharmacie - Droit européen ram Europarecht Recht Drugs Law and legislation European Union countries Pharmaceutical industry European Union countries Arzneimittelhandel (DE-588)4143178-9 gnd Binnenmarkt (DE-588)4145576-9 gnd |
| topic_facet | European Community Europäische Gemeinschaften Europees recht Farmaceutische industrie Harmonisatie Médicaments - Droit européen Pharmacie - Droit européen Europarecht Recht Drugs Law and legislation European Union countries Pharmaceutical industry European Union countries Arzneimittelhandel Binnenmarkt Europäische Union. Mitgliedsstaaten |
| url | http://bvbr.bib-bvb.de:8991/F?func=service&doc_library=BVB01&local_base=BVB01&doc_number=006581943&sequence=000001&line_number=0001&func_code=DB_RECORDS&service_type=MEDIA |
| work_keys_str_mv | AT thompsonrhodri thesinglemarketforpharmaceuticals |