Guideline on good pharmacovigilance practices …

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/876333/2011 2 Guideline on good pharmacovigilance practices (GVP) 3 Annex I - Definitions 4 Draft finalised by the Agency in collaboration with Member States 7 February 2012 Definitions agreed by ERMS FG as part of the draft GVP Modules 24 January 2012 Draft adopted by Executive Director 20 February 2012 Start of public consultation 21 February 2012 End of consultation (deadline for comments)

2 18 April 2012 Anticipated date for coming into effect after finalisation July 2012 5 Comments should be provided using this template. The completed comments form should be sent to 6 7 Guideline on good pharmacovigilance practices (GVP) Annex I EMA/876333/2011 Page 2/14 Table of contents 8 Abuse of a medicinal product .. 4 9 Adverse event (AE); synonym: Adverse experience .. 4 10 Adverse reaction; synonyms: Adverse drug reaction (ADR), Suspected adverse (drug) 11 reaction .. 4 12 Clinical trial .. 4 13 Closed signal .. 4 14 Consumer .. 5 15 Company core data sheet (CCDS).

3 5 16 Company core safety information (CCSI) .. 5 17 Completed clinical trial .. 5 18 Data lock point .. 5 19 Development international birth date (DIBD) .. 5 20 Development safety update report (DSUR) .. 6 21 EU reference date; synonym: Union reference date .. 6 22 good pharmacovigilance practices (GVP) for the European Union .. 6 23 Healthcare professional .. 6 24 Identified risk .. 6 25 Important identified risk, important potential risk .. 6 26 Important missing information .. 7 27 Individual case safety report (ICSR); synonym: Adverse (drug) reaction report.

4 7 28 International birth date (IBD) .. 7 29 Investigational drug .. 7 30 Listed adverse reaction .. 7 31 Medication error .. 7 32 Medicinal product .. 8 33 Missing information .. 8 34 Misuse .. 8 35 Name of the medicinal product .. 8 36 Newly identified signal .. 8 37 Non-interventional studies .. 8 38 Occupational exposure .. 9 39 Ongoing clinical trial .. 9 40 Ongoing signal .. 9 41 Overdose .. 9 42 Periodic safety update report (PSUR) .. 9 43 pharmacovigilance .. 9 44 pharmacovigilance system .. 10 45 pharmacovigilance system master file (PSMF).

5 10 46 Post-authorisation safety study (PASS) .. 10 47 Potential risk .. 10 48 Quality assurance .. 11 49 Quality control .. 11 50 Quality of a pharmacovigilance system .. 11 51 Quality requirements .. 11 52 Quality system of a pharmacovigilance system .. 11 53 Guideline on good pharmacovigilance practices (GVP) Annex I EMA/876333/2011 Page 3/14 Reference safety information .. 11 54 Risk-benefit balance .. 11 55 Risk management system .. 11 56 Risk management plan .. 11 57 Risk minimisation activity; synonym: Risk minimisation measure .. 12 58 Risks related to use of a medicinal 12 59 Safety concern.

6 12 60 Serious adverse reaction .. 12 61 Signal .. 13 62 Significant change in indication .. 13 63 Solicited sources of individual case safety reports .. 13 64 Spontaneous report, synonym: Spontaneous notification .. 13 65 Target population (treatment); synonym: Treatment target population .. 14 66 Unexpected adverse reaction .. 14 67 Validated signal .. 14 68 69 70 Guideline on good pharmacovigilance practices (GVP) Annex I EMA/876333/2011 Page 4/14 Abuse of a medicinal product 71 Persistent or sporadic, intentional excessive use of medicinal products which is accompanied by 72 harmful physical or psychological effects [DIR 2001/83/EC Art 1(16)].

7 73 Adverse event (AE); synonym: Adverse experience 74 Any untoward medical occurrence in a patient or clinical-trial subject administered a medicinal product 75 and which does not necessarily have to have a causal relationship with this treatment [Dir 2001/20/EC 76 Art 2(m)]. 77 An adverse event can therefore be any unfavourable and unintended sign ( an abnormal laboratory 78 finding), symptom, or disease temporally associated with the use of a medicinal product, whether or 79 not considered related to the medicinal product. 80 Adverse reaction; synonyms: Adverse drug reaction (ADR), Suspected adverse (drug) 81 reaction 82 A response to a medicinal product which is noxious and unintended [DIR 2001/83/EC Art 1(11)].

8 83 Response in this context means that a causal relationship between a medicinal product and an adverse 84 event is at least a reasonable possibility (see Annex IV, ICH-E2A Guideline ). 85 Adverse reactions may arise from use of the product within or outside the terms of the marketing 86 authorisation or from occupational exposure [DIR 2001/83/EC Art 101(1)]. Conditions of use outside 87 the marketing authorisation include overdose, misuse, abuse and medication errors. 88 See also Adverse event, Serious adverse reaction, Unexpected adverse reaction, Listed adverse 89 reaction, Unlisted adverse reaction, Overdose, Misuse, Abuse, Medication error, Occupational exposure 90 Clinical trial 91 Any investigation in human subjects intended to discover or verify the clinical, pharmacological and/or 92 other pharmacodynamic effects of one or more investigational medicinal product(s), and/or to identify 93 any adverse reactions to one or more investigational medicinal product(s)

9 And/or to study absorption, 94 distribution, metabolism and excretion of one or more investigational medicinal product(s) with the 95 objective of ascertaining its (their) safety and/or efficacy. This includes clinical trials carried out in 96 either one site or multiple sites, whether in one or more Member State [Dir 2001/20/EC Art 2(a)]. 97 An investigational medicinal product is a pharmaceutical form of an active substance or placebo being 98 tested or used as a reference in a clinical trial, including products already with a marketing 99 authorisation but used or assembled (formulated or packaged) in a way different from the authorised 100 form, or when used for an unauthorised indication, or when used to gain further information about the 101 authorised form [Dir 2001/20/EC Art 2(d)].

10 102 See also Ongoing clinical trial, Completed clinical trial 103 Closed signal 104 In periodic benefit-risk evaluation reports, a signal for which an evaluation was completed during the 105 reporting interval (see Annex IV, ICH-E2C(R2) Guideline ). 106 See also Signal 107 Guideline on good pharmacovigilance practices (GVP) Annex I EMA/876333/2011 Page 5/14 Company core data sheet (CCDS) 108 A document prepared by the marketing authorisation holder containing, in addition to safety 109 information, material relating to indications, dosing, pharmacology and other information concerning 110 the product (see Annex IV, ICH-E2C(R2) Guideline ).