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Guideline on good pharmacovigilance practices (GVP)

See websites for contact details European Medicines Agency Heads of Medicines Agencies The European Medicines Agency is an agency of the European Union European Medicines Agency and Heads of Medicines Agencies, 2012. Reproduction is authorised provided the source is acknowledged. 20 February 2012 1 EMA/873138/2011 2 Guideline on good pharmacovigilance practices (GVP) 3 Module VI Management and reporting of adverse reactions to medicinal 4 products 5 Draft finalised by the agency in collaboration with Member States and submitted to ERMS FG 19 January 2012 Draft agreed by ERMS FG 24 January 2012 Draft adopted by Executive Director 20 February 2012 Start of public consultation 21 February 2012 End of consultation (deadline for comments) 18 April 2012 Anticipated date for coming into effect after finalisation July 2012 6 Comments should be provided using this template.

Guideline on good pharmacovigilance practices (GVP) – Module VI EMA/873138/2011 Page 2/84 9

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Transcription of Guideline on good pharmacovigilance practices (GVP)

1 See websites for contact details European Medicines Agency Heads of Medicines Agencies The European Medicines Agency is an agency of the European Union European Medicines Agency and Heads of Medicines Agencies, 2012. Reproduction is authorised provided the source is acknowledged. 20 February 2012 1 EMA/873138/2011 2 Guideline on good pharmacovigilance practices (GVP) 3 Module VI Management and reporting of adverse reactions to medicinal 4 products 5 Draft finalised by the agency in collaboration with Member States and submitted to ERMS FG 19 January 2012 Draft agreed by ERMS FG 24 January 2012 Draft adopted by Executive Director 20 February 2012 Start of public consultation 21 February 2012 End of consultation (deadline for comments) 18 April 2012 Anticipated date for coming into effect after finalisation July 2012 6 Comments should be provided using this template.

2 The completed comments form should be sent to 7 8 Guideline on good pharmacovigilance practices (GVP) Module VI EMA/873138/2011 Page 2/84 TABLE OF CONTENTS 9 Introduction .. 5 10 Scope .. 5 11 Definitions .. 5 12 Adverse reaction .. 5 13 Causality .. 5 14 Overdose, misuse, abuse, medication error, occupational exposure .. 6 15 Medicinal product .. 6 16 Primary source .. 7 17 Seriousness .. 7 18 Individual Case Safety Report (ICSR) .. 8 19 Structures and Processes .. 9 20 Collection of reports .. 9 21 Unsolicited reports .. 9 22 Spontaneous reports .. 9 23 Literature reports .. 9 24 Reports from other sources .. 10 25 Information on suspected adverse reactions from the internet or digital media . 10 26 Solicited reports .. 11 27 Validation of reports.

3 11 28 Follow-up of reports .. 12 29 Data management .. 13 30 Quality management .. 14 31 Special situations .. 14 32 Use of a medicinal product during pregnancy or breastfeeding .. 14 33 Use of a medicinal product in a paediatric or elderly population .. 15 34 Reports of overdose, abuse, misuse, medication error or occupational exposure . 16 35 Lack of therapeutic efficacy .. 16 36 Expedited reporting of ICSRs .. 17 37 Expedited reporting time frames .. 17 38 Reporting modalities .. 17 39 Operation of the EU Network .. 19 40 Interface with safety reporting rules for clinical trials in the EU .. 19 41 Collection of reports .. 21 42 Member States responsibilities .. 21 43 Marketing authorisation holders responsibilities .. 22 44 Spontaneous reports .. 22 45 Solicited reports.

4 23 46 Reports from non-interventional studies .. 23 47 Compassionate use, named patient use .. 24 48 Patient support 24 49 Reports published in the scientific and medical literature .. 24 50 Suspected adverse reactions related to quality defect or falsified medicinal 51 products .. 25 52 Guideline on good pharmacovigilance practices (GVP) Module VI EMA/873138/2011 Page 3/84 Suspected transmission via a medicinal product of an infectious agent .. 26 53 Emerging safety issues .. 26 54 Period between the submission of the marketing authorisation application and 55 the granting of the marketing authorisation .. 27 56 Period after suspension, revocation or withdrawal of marketing authorisation .. 27 57 Period during a public health emergency .. 28 58 Reports from class action lawsuits.

5 28 59 Expedited reporting time frames .. 28 60 Reporting modalities .. 28 61 Interim arrangements .. 29 62 Final arrangements .. 29 63 Collaboration with the World Health Organization and the European Monitoring 64 Centre for Drugs and Drug Addiction .. 30 65 Electronic exchange of safety information in the EU .. 30 66 Applicable guidelines, definitions, international formats, standards and 67 terminologies .. 31 68 Electronic Reporting of Individual Case Safety Reports .. 31 69 EudraVigilance Database Modules .. 31 70 Adverse reaction data collected in the EudraVigilance Post-Authorisation 71 Module .. 31 72 Adverse Reaction Data Collected in the EudraVigilance Clinical Trial Module .. 32 73 Preparation of Individual Case Safety Reports .. 32 74 General principles.

6 32 75 Information on suspect, interacting and concomitant medicinal products .. 33 76 Suspected adverse reactions .. 34 77 Case narrative and causality assessment .. 35 78 Test results .. 36 79 Supplementary information .. 36 80 Follow-up information .. 36 81 What to take into account for data privacy laws .. 37 82 Handling of languages .. 38 83 Nullification of cases .. 38 84 Special situations .. 38 85 Use of a medicinal product during pregnancy or breastfeeding .. 38 86 Suspected adverse reaction reports published in the scientific and medical 87 literature .. 39 88 Suspected adverse reactions related to overdose, abuse, misuse, medication 89 error or occupational exposure .. 39 90 Lack of therapeutic efficacy .. 40 91 Suspected adverse reactions related to quality defect or falsified medicinal 92 products.

7 40 93 Suspected transmission via a medicinal product of an infectious agent .. 40 94 Reports originating in non-interventional organised data collection schemes . 41 95 Receipt of missing minimum information .. 41 96 Data quality of individual case safety reports transmitted electronically and 97 duplicate management .. 41 98 Electronic re-transmission of ICSRs between multiple senders and receivers .. 42 99 Guideline on good pharmacovigilance practices (GVP) Module VI EMA/873138/2011 Page 4/84 Electronic reporting through company s headquarters .. 43 100 Electronic submission of information on medicinal products .. 43 101 1. Identification of biological medicinal products .. 44 102 2. Detailed guidance on the monitoring of scientific and 103 medical literature .. 47 104 3.

8 Modalities for expedited reporting .. 56 105 Interim arrangements .. 56 106 Interim arrangements applicable to marketing authorisation holders .. 61 107 Interim arrangements applicable to competent authorities in Member 108 States .. 61 109 Final arrangements .. 62 110 Final arrangements applicable to marketing authorisation 65 111 Final arrangements applicable to competent authorities in Member States112 .. 65 113 Transmission and rerouting of ICSRs to competent authorities in Member 114 States .. 66 115 4. Transmission of ICSRs to World Health Organisation (WHO) 116 Collaborating Centre .. 70 117 5. Nullification of cases .. 74 118 6. Data quality monitoring of ICSRs transmitted electronically119 .. 78 120 7. Duplicate detection and management of ICSRs.

9 81 121 122 123 Guideline on good pharmacovigilance practices (GVP) Module VI EMA/873138/2011 Page 5/84 Introduction 124 Scope 125 This Module addresses the legal requirements detailed in Title IX of Directive 2001/83/EC and Chapter 126 3 of Regulation (EC) No 726/2004, which are applicable to competent authorities in Member States, 127 marketing authorisation holders and the Agency as regards the collection, data management and 128 reporting of suspected adverse reactions associated with medicinal products for human use authorised 129 in the European Union (EU ). Recommendations regarding the reporting of suspected adverse reactions 130 occurring in special situations are also included in this Module. 131 All applicable legal requirements are referenced in the way explained in the GVP Introductory Cover 132 Note and are usually identifiable by the modal verb shall.

10 Guidance for the implementation of legal 133 requirements is provided using the modal verb should . 134 Definitions 135 The definitions provided in Article 1 of Directive 2001/83/EC shall be applied for the purpose of this 136 Module; of particular relevance are those provided in this Chapter. Some general principles presented 137 in the ICH-E2A and ICH-E2D guidelines1 and in the Commission Implementing Regulation on the 138 Performance of pharmacovigilance Activities Provided for in Regulation (EC) No 726/2004 and Directive 139 2001/83/EC should also be adhered to; they are included as well in this Chapter. 140 Adverse reaction 141 An adverse reaction is a response to a medicinal product which is noxious and unintended [DIR Art 1]. 142 This includes adverse reactions which arise from: 143 use of a medicinal product within the terms of the marketing authorisation; 144 use outside the terms of the marketing authorisation, including overdose, misuse, abuse and 145 medication errors; 146 occupational exposure.


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