Notice to applicants: medicinal products for human use: A. Procedures for marketing authorisation
Gespeichert in:
| Format: | Buch |
|---|---|
| Sprache: | English |
| Veröffentlicht: |
Luxembourg
Office for Official Publ. of the Europ. Communities
1998
|
| Schriftenreihe: | The rules governing medicinal products in the European Union
Vol. 2 |
| Online-Zugang: | Inhaltsverzeichnis |
| Beschreibung: | X, 175 S. |
| ISBN: | 9282820602 |
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| 245 | 1 | 0 | |a Notice to applicants: medicinal products for human use |n A. |p Procedures for marketing authorisation |c European Commission, Directorate General III - Industry, Pharmaceuticals and Cosmetics |
| 264 | 1 | |a Luxembourg |b Office for Official Publ. of the Europ. Communities |c 1998 | |
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| 490 | 1 | |a The rules governing medicinal products in the European Union |v Vol. 2 | |
| 490 | 0 | |a The rules governing medicinal products in the European Union |v Vol. 2 | |
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Datensatz im Suchindex
| _version_ | 1804138270947278848 |
|---|---|
| adam_text | CHAPTER 1 MARKETING AUTHORISATIONS 1
1. Introduction 1
1.1 Objectives 1
1.2 Status 1
2. Marketing Authorisation 1
2.1 National authorisations 2
2.2 Community authorisations 2
2.3 Invented name (Brand name) 3
3. Community procedures 3
3.1 Community marketing authorisation 3
3.2 Mutual recognition 4
3.3 Community referrals 4
4. Stand-alone applications for a marketing authorisation 5
4.1 Full application 5
4.2 Bibliographical applications 6
5. Abridged applications for a marketing authorisation 6
5.1 Informed consent from a marketing authorisation holder 7
5.2 Product essentially similar to a product authorised for 6 or 10 years (generic
product) 7
5.3 Implementation of Art. 5 (10)(a)(iii) of Directive 81/851/EEC 8
5.4 Other abridged applications 9
6. Application for a Variation 11
6.1 Regulations on variations 11
6.2 Urgent safety restrictions 11
6.4 National procedures 12
7. Other applications 13
7.1 Labelling changes 13
7.2 Application for a manufacturing authorisation 13
7.3 Application for renewal 13
7.4 Transfer of a marketing authorisation 14
7.5 Special requirements for veterinary medicinal product intended for
administration to food-producing animals 14
7.5.1 Background 14
7.5.2 Preconditions for granting a marketing authorisation 14
CHAPTER 2 MUTUAL RECOGNITION 17
1. Legal Basis and purpose 17
2. Scope 19
2.1 Applications eligible for the mutual recognition procedure 19
2.2 Repeat use 19
2.3 Exclusions 20
2.4 Residue of veterinary medicinal products in foodstuffs of animal origin 20
3. Initiation by a Member State 20
3.1 Suspension of detailed examination 20
3.2 Mutual recognition by a Member State 21
V
4. Initiation by the marketing authorisation holder (MAH) 22
4.1 Discussion with the Reference Member State 22
4.2 Updating the dossier and Expert Reports (if necessary) 23
4.3 Assessment Report 24
4.4 Before submitting the application 24
4.5 Making the application 25
4.6 Notification to the CVMP 26
5. Action following the submission of the application 27
5.1 Check-in procedure 27
5.2 Flexible starting date 27
5.3 Recognition of the original authorisation 27
5.4 Clarification and dialogue - Operating procedure 28
5.5 Changes to the authorisation in the Reference Member State 29
5.6 Maintenance of identical dossiers 29
6. Procedures for the national transfer of the MAH 29
7. Renewal of the marketing authorisation 33
7.1 Optional procedure for earlier renewal 33
7.2 Making the application 34
7.3 Impact on periodic safety update reports 34
7.4 Ex-concertation products 35
7.5 Making the application 35
7.6 Procedure 35
8. Numbering system for the procedures for mutual recognition 37
CHAPTER 3 COMMUNITY REFERRAL .. 41
1. Legal basis and scope 41
2. Referral to the Committee 41
2.1 Making the referral 41
2.2 What should the report contain? 42
2.3 Can the referral be withdrawn? 42
2.4 The question referred to the Committee 42
2.5 Supporting elements 42
2.6 Initial assessment report of the RMS - Translation 43
2.7 SPC 43
2.8 Notification form 44
3. Article 19 referrals 45
3.1 Objective and scope 45
3.2 Procedure for article 19 referral 46
3.3 Time-frame 46
4. Article 20 referrals 46
4.1 Objective and scope 47
4.2 Procedure for Article 20 referral 47
4.3 Time-frame 47
5. Variations and suspensions by Authorities 48
6. The arbitration procedure 48
6.1 Appointment of Rapporteur 48
6.2 Timetable for the arbitration 48
6.3 Oral explanation 49
6.4 The Scientific Committee opinion 49
6.5 Appeal and final opinion 49
6.6 When does the Scientific Committee s opinion become final? 50
7. Commission Decision and its implementation by Member States 50
CHAPTER 4 CENTRALISED PROCEDURE 51
1. Legal basis and purpose 51
2. Scope 51
2.1 Part A - Veterinary medicinal products derived from biotechnology 52
2.2 Part B - Innovatory veterinary medicinal products 52
3. Scientific advice to companies 53
3.1 Necessity for advice 53
3.2 Scope of advice 54
3.3 Consultation procedure 54
4. Procedure for the submission of an application 54
4.1 Four to six months before submission 55
4.2 Three months before submission 57
4.3 Submission of the application and payment of fees 59
4.3.1 Dossier to be submitted 59
4.3.2 Payment of fees 60
4.4 Validation by the EMEA Secretariat 60
4.4.1 Positive outcome of the validation 60
4.4.2 Negative outcome of the validation 61
4.5 Management of applications 61
4.6 Need for sample analysis 61
5. Pre-authorisation inspections 61
5.1 Pre-submission notification by the applicant for a marketing authorisation 62
5.2 Designation of an inspection team and preparation of the inspection 62
5.3 Contacts with the applicant and the manufacturer(s) to be inspected 63
5.4 Inspection and transmission of the report and check on the importer 63
5.5 Submission of the final report to the Rapporteur and the EMEA 64
6. Scientific evaluation by the CVMP 64
6.1 Timetable for the evaluation 64
6.2 Liaison between the applicant and the EMEA 65
6.3 CVMP s request for additional information 66
6.4 Oral explanation 66
7. The Committee s opinion 68
7.1 Favourable opinion 68
7.2 Follow-up measures and specific obligations 69
7.3 Unfavourable opinions 69
8. Follow-up to the CVMP opinion 70
8.1 Translations of the CVMP opinion 70
8.2 Transmission of the CVMP opinion 70
8.3 Appeal 70
8.4 European Public Assessment Report (EPAR) 71
8.4.1 Operating approach to the preparation of the EPAR 71
8.4.2 Availability of the EPAR 71
8.5 Negative decision 71
9. Transfer of a marketing authorisation granted by the Community 72
10. Renewal of a marketing authorisation 73
CHAPTER 5 VARIATIONS 75
1. Introduction 75
2. Changes to a marketing authorisation 75
2.1 Variations 75
2.2 Changes to the labelling or package insert 76
3. Procedural guidance for mutual recognition variations 77
3.1 Mutual recognition variations (Type I) 77
3.1.1 Action by the Reference Member State (RMS) - Type I variation 77
3.1.2 Action by the Concerned Member States (CMS) - Type I variation 78
3.1.3 Action by the applicant - Type I variation 79
3.2 Mutual recognition variations - Type II 81
3.2.1 Action by the Reference Member State - Type II variation 81
3.2.2 Action by the Concerned Member States (CMS) - Type II Variation 82
3.2.3 Action by the applicant - Type II variation 83
4. Procedural guidance for centralised variations 85
4.1 General 85
4.2 Scope 85
4.3 Preliminary steps 85
4.4 Procedure for obtaining a Type I variation 86
4.5 Procedure for obtaining a Type II variation 86
4.6 Changes imposed by the need to adopt urgent safety restrictions 88
4.7 Changes leading to a new marketing authorisation 88
5. Application form for a variation to a marketing authorisation 89
6. Completion of the application form 92
6.1 Purpose of the application form 92
6.2 Filling in the application form 92
6.2.1 Page 1 92
6.2.2 Page 2 93
6.2.3 Page 3 93
6.2.4 Appendix 94
6.2.5 Copies of form and data 94
7. Guideline on dossier requirements for Type I variations 95
8. Type II variation applications (V) versus new applications (NA) 110
8.1 Definitions and principles 110
8.2 Oral preparations Ill
8.3 Parenteral preparations Ill
8.4 Preparations for inhalation 112
8.5 Local preparations 112
8.6 Rectal or vaginal use 113
ANNEX 114
Variation Type I, number 1 114
CHAPTER 6 COMMUNITY MARKETING AUTHORISATION 115
1. Legal basis and scope 115
2. Decision making process 115
2.1 Check-in procedure 115
2.2 Preparing the draft decision 116
2.3 Internal consultation 118
2.4 Standing Committee - Written procedure 118
2.5 Standing Committee meeting 119
2.6 Finalising a Commission Decision 119
2.7 Submission to the Council 120
3. Information on veterinary medicinal products authorised by the Community 120
3.1 Legal framework 120
3.2 Legal status 121
3.2.1 Article 31 (3) (c) of Council Regulation 2309/93 121
3.2.2 The Community Decision 121
3.3 Changes to the labelling and/or package insert 121
Section A - Label 121
Section B - Package Insert 124
Section C - Presentation of the medicinal product 125
4. Parallel distribution of medicines authorised by the Community 125
4.1 General principle 125
4.2 The particular case in which repackaging is carried out 126
4.3 Indication that the medicine has been repackaged and of its origin 127
4.4 Informing the trade mark owner 127
ANNEX 129
Label information which may be required by Member States 129
CHAPTER 7 GENERAL INFORMATION 135
APPLICATIONS FOR MARKETING AUTHORISATION IN THE E.U 135
1. Languages to be used for dossier, responses and variations 136
2. Number of copies of the dossier, responses and variations 137
3. Dossier check-in procedure 138
4. Specimens and samples 139
5. List of Official Journals 141
6. Addresses for delivery of the dossier and subsequent correspondence 143
7. Addresses for receipt of fees and terms for payment 146
LIST OF ABBREVIATIONS 155
|
| adam_txt |
CHAPTER 1 MARKETING AUTHORISATIONS 1
1. Introduction 1
1.1 Objectives 1
1.2 Status 1
2. Marketing Authorisation 1
2.1 National authorisations 2
2.2 Community authorisations 2
2.3 Invented name (Brand name) 3
3. Community procedures 3
3.1 Community marketing authorisation 3
3.2 Mutual recognition 4
3.3 Community referrals 4
4. Stand-alone applications for a marketing authorisation 5
4.1 Full application 5
4.2 Bibliographical applications 6
5. Abridged applications for a marketing authorisation 6
5.1 Informed consent from a marketing authorisation holder 7
5.2 Product essentially similar to a product authorised for 6 or 10 years (generic
product) 7
5.3 Implementation of Art. 5 (10)(a)(iii) of Directive 81/851/EEC 8
5.4 Other abridged applications 9
6. Application for a Variation 11
6.1 Regulations on variations 11
6.2 Urgent safety restrictions 11
6.4 National procedures 12
7. Other applications 13
7.1 Labelling changes 13
7.2 Application for a manufacturing authorisation 13
7.3 Application for renewal 13
7.4 Transfer of a marketing authorisation 14
7.5 Special requirements for veterinary medicinal product intended for
administration to food-producing animals 14
7.5.1 Background 14
7.5.2 Preconditions for granting a marketing authorisation 14
CHAPTER 2 MUTUAL RECOGNITION 17
1. Legal Basis and purpose 17
2. Scope 19
2.1 Applications eligible for the mutual recognition procedure 19
2.2 Repeat use 19
2.3 Exclusions 20
2.4 Residue of veterinary medicinal products in foodstuffs of animal origin 20
3. Initiation by a Member State 20
3.1 Suspension of detailed examination 20
3.2 Mutual recognition by a Member State 21
V
4. Initiation by the marketing authorisation holder (MAH) 22
4.1 Discussion with the Reference Member State 22
4.2 Updating the dossier and Expert Reports (if necessary) 23
4.3 Assessment Report 24
4.4 Before submitting the application 24
4.5 Making the application 25
4.6 Notification to the CVMP 26
5. Action following the submission of the application 27
5.1 Check-in procedure 27
5.2 Flexible starting date 27
5.3 Recognition of the original authorisation 27
5.4 Clarification and dialogue - Operating procedure 28
5.5 Changes to the authorisation in the Reference Member State 29
5.6 Maintenance of identical dossiers 29
6. Procedures for the national transfer of the MAH 29
7. Renewal of the marketing authorisation 33
7.1 Optional procedure for earlier renewal 33
7.2 Making the application 34
7.3 Impact on periodic safety update reports 34
7.4 Ex-concertation products 35
7.5 Making the application 35
7.6 Procedure 35
8. Numbering system for the procedures for mutual recognition 37
CHAPTER 3 COMMUNITY REFERRAL '. 41
1. Legal basis and scope 41
2. Referral to the Committee 41
2.1 Making the referral 41
2.2 What should the report contain? 42
2.3 Can the referral be withdrawn? 42
2.4 The question referred to the Committee 42
2.5 Supporting elements 42
2.6 Initial assessment report of the RMS - Translation 43
2.7 SPC 43
2.8 Notification form 44
3. Article 19 referrals 45
3.1 Objective and scope 45
3.2 Procedure for article 19 referral 46
3.3 Time-frame 46
4. Article 20 referrals 46
4.1 Objective and scope 47
4.2 Procedure for Article 20 referral 47
4.3 Time-frame 47
5. Variations and suspensions by Authorities 48
6. The arbitration procedure 48
6.1 Appointment of Rapporteur 48
6.2 Timetable for the arbitration 48
6.3 Oral explanation 49
6.4 The Scientific Committee opinion 49
6.5 Appeal and final opinion 49
6.6 When does the Scientific Committee's opinion become final? 50
7. Commission Decision and its implementation by Member States 50
CHAPTER 4 CENTRALISED PROCEDURE 51
1. Legal basis and purpose 51
2. Scope 51
2.1 Part A - Veterinary medicinal products derived from biotechnology 52
2.2 Part B - Innovatory veterinary medicinal products 52
3. Scientific advice to companies 53
3.1 Necessity for advice 53
3.2 Scope of advice 54
3.3 Consultation procedure 54
4. Procedure for the submission of an application 54
4.1 Four to six months before submission 55
4.2 Three months before submission 57
4.3 Submission of the application and payment of fees 59
4.3.1 Dossier to be submitted 59
4.3.2 Payment of fees 60
4.4 Validation by the EMEA Secretariat 60
4.4.1 Positive outcome of the validation 60
4.4.2 Negative outcome of the validation 61
4.5 Management of applications 61
4.6 Need for sample analysis 61
5. Pre-authorisation inspections 61
5.1 Pre-submission notification by the applicant for a marketing authorisation 62
5.2 Designation of an inspection team and preparation of the inspection 62
5.3 Contacts with the applicant and the manufacturer(s) to be inspected 63
5.4 Inspection and transmission of the report and check on the importer 63
5.5 Submission of the final report to the Rapporteur and the EMEA 64
6. Scientific evaluation by the CVMP 64
6.1 Timetable for the evaluation 64
6.2 Liaison between the applicant and the EMEA 65
6.3 CVMP's request for additional information 66
6.4 Oral explanation 66
7. The Committee's opinion 68
7.1 Favourable opinion 68
7.2 Follow-up measures and specific obligations 69
7.3 Unfavourable opinions 69
8. Follow-up to the CVMP opinion 70
8.1 Translations of the CVMP opinion 70
8.2 Transmission of the CVMP opinion 70
8.3 Appeal 70
8.4 European Public Assessment Report (EPAR) 71
8.4.1 Operating approach to the preparation of the EPAR 71
8.4.2 Availability of the EPAR 71
8.5 Negative decision 71
9. Transfer of a marketing authorisation granted by the Community 72
10. Renewal of a marketing authorisation 73
CHAPTER 5 VARIATIONS 75
1. Introduction 75
2. Changes to a marketing authorisation 75
2.1 Variations 75
2.2 Changes to the labelling or package insert 76
3. Procedural guidance for mutual recognition variations 77
3.1 Mutual recognition variations (Type I) 77
3.1.1 Action by the Reference Member State (RMS) - Type I variation 77
3.1.2 Action by the Concerned Member States (CMS) - Type I variation 78
3.1.3 Action by the applicant - Type I variation 79
3.2 Mutual recognition variations - Type II 81
3.2.1 Action by the Reference Member State - Type II variation 81
3.2.2 Action by the Concerned Member States (CMS) - Type II Variation 82
3.2.3 Action by the applicant - Type II variation 83
4. Procedural guidance for centralised variations 85
4.1 General 85
4.2 Scope 85
4.3 Preliminary steps 85
4.4 Procedure for obtaining a Type I variation 86
4.5 Procedure for obtaining a Type II variation 86
4.6 Changes imposed by the need to adopt urgent safety restrictions 88
4.7 Changes leading to a new marketing authorisation 88
5. Application form for a variation to a marketing authorisation 89
6. Completion of the application form 92
6.1 Purpose of the application form 92
6.2 Filling in the application form 92
6.2.1 Page 1 92
6.2.2 Page 2 93
6.2.3 Page 3 93
6.2.4 Appendix 94
6.2.5 Copies of form and data 94
7. Guideline on dossier requirements for Type I variations 95
8. Type II variation applications (V) versus new applications (NA) 110
8.1 Definitions and principles 110
8.2 Oral preparations Ill
8.3 Parenteral preparations Ill
8.4 Preparations for inhalation 112
8.5 Local preparations 112
8.6 Rectal or vaginal use 113
ANNEX 114
Variation Type I, number 1 114
CHAPTER 6 COMMUNITY MARKETING AUTHORISATION 115
1. Legal basis and scope 115
2. Decision making process 115
2.1 Check-in procedure 115
2.2 Preparing the draft decision 116
2.3 Internal consultation 118
2.4 Standing Committee - Written procedure 118
2.5 Standing Committee meeting 119
2.6 Finalising a Commission Decision 119
2.7 Submission to the Council 120
3. Information on veterinary medicinal products authorised by the Community 120
3.1 Legal framework 120
3.2 Legal status 121
3.2.1 Article 31 (3) (c) of Council Regulation 2309/93 121
3.2.2 The Community Decision 121
3.3 Changes to the labelling and/or package insert 121
Section A - Label 121
Section B - Package Insert 124
Section C - Presentation of the medicinal product 125
4. Parallel distribution of medicines authorised by the Community 125
4.1 General principle 125
4.2 The particular case in which repackaging is carried out 126
4.3 Indication that the medicine has been repackaged and of its origin 127
4.4 Informing the trade mark owner 127
ANNEX 129
Label information which may be required by Member States 129
CHAPTER 7 GENERAL INFORMATION 135
APPLICATIONS FOR MARKETING AUTHORISATION IN THE E.U 135
1. Languages to be used for dossier, responses and variations 136
2. Number of copies of the dossier, responses and variations 137
3. Dossier check-in procedure 138
4. Specimens and samples 139
5. List of Official Journals 141
6. Addresses for delivery of the dossier and subsequent correspondence 143
7. Addresses for receipt of fees and terms for payment 146
LIST OF ABBREVIATIONS 155 |
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| indexdate | 2024-07-09T21:25:32Z |
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| institution_GND | (DE-588)2170208-1 |
| isbn | 9282820602 |
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| series | The rules governing medicinal products in the European Union |
| series2 | The rules governing medicinal products in the European Union |
| spelling | Notice to applicants: medicinal products for human use A. Procedures for marketing authorisation European Commission, Directorate General III - Industry, Pharmaceuticals and Cosmetics Luxembourg Office for Official Publ. of the Europ. Communities 1998 X, 175 S. txt rdacontent n rdamedia nc rdacarrier The rules governing medicinal products in the European Union Vol. 2 Europäische Kommission Generaldirektion Industrie, Arzneimittel und Kosmetika Sonstige (DE-588)2170208-1 oth (DE-604)BV023566909 1 The rules governing medicinal products in the European Union Vol. 2 (DE-604)BV023548033 2,1 HBZ Datenaustausch application/pdf http://bvbr.bib-bvb.de:8991/F?func=service&doc_library=BVB01&local_base=BVB01&doc_number=016923464&sequence=000002&line_number=0001&func_code=DB_RECORDS&service_type=MEDIA Inhaltsverzeichnis |
| spellingShingle | Notice to applicants: medicinal products for human use The rules governing medicinal products in the European Union |
| title | Notice to applicants: medicinal products for human use |
| title_auth | Notice to applicants: medicinal products for human use |
| title_exact_search | Notice to applicants: medicinal products for human use |
| title_exact_search_txtP | Notice to applicants: medicinal products for human use |
| title_full | Notice to applicants: medicinal products for human use A. Procedures for marketing authorisation European Commission, Directorate General III - Industry, Pharmaceuticals and Cosmetics |
| title_fullStr | Notice to applicants: medicinal products for human use A. Procedures for marketing authorisation European Commission, Directorate General III - Industry, Pharmaceuticals and Cosmetics |
| title_full_unstemmed | Notice to applicants: medicinal products for human use A. Procedures for marketing authorisation European Commission, Directorate General III - Industry, Pharmaceuticals and Cosmetics |
| title_short | Notice to applicants: medicinal products for human use |
| title_sort | notice to applicants medicinal products for human use procedures for marketing authorisation |
| url | http://bvbr.bib-bvb.de:8991/F?func=service&doc_library=BVB01&local_base=BVB01&doc_number=016923464&sequence=000002&line_number=0001&func_code=DB_RECORDS&service_type=MEDIA |
| volume_link | (DE-604)BV023566909 (DE-604)BV023548033 |
| work_keys_str_mv | AT europaischekommissiongeneraldirektionindustriearzneimittelundkosmetika noticetoapplicantsmedicinalproductsforhumanusea |