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Guideline on Risk Management Systems for Medicinal Products for ...
Source: www.emea.europa.eu
Topic: Risk Management
Sort Desciption: A risk management system is defined in this guideline as a set of ... The guideline also describes how such a risk management system can be ...
Content Inside: European Medicines Agency Post-authorisation Evaluation of Medicines for Human Use 7 Westferry Circus Canary Wharf London E14 4HB UK Tel. (44-20) 74 18 84 00 Fax (44-20) 74 18 86 68 E-mail: mail@emea.eu.int http://www.emea.eu.int EMEA 2005 Reproduction and/or distribution of this document is authorised for non-commercial purposes only provided the EMEA is acknowledged London 14 November 2005 Doc. Ref. EMEA/CHMP/96268/2005 COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE (CHMP) GUIDELINE ON RISK MANAGEMENT SYSTEMS FOR MEDICINAL PRODUCTS FOR HUMAN USE DRAFT AGREED BY PhVWP 26 July 2005 ADOPTION BY CHMP FOR RELEASE FOR CONSULTATION 27 July 2005 END OF CONSULTATION (DEADLINE FOR COMMENTS) 5 October 2005 ADOPTION BY CHMP 14 November 2005 DATE FOR COMING INTO EFFECT 20 November 2005 THIS GUIDELINE WILL BE INCLUDED AS CHAPTER I.3 OF VOLUME 9 EMEA/CHMP/96268/2005 Page 2/32 EMEA 2005 GUIDELINE ON RISK MANAGEMENT SYSTEMS FOR MEDICINAL PRODUCTS FOR HUMAN USE 1. INTRODUCTION (background) 4 2. SCOPE 5 3. LEGAL BASIS 5 4. RISK MANAGEMENT DESCRIPTION AND THE REQUIREMENTS FOR APPLICANTS AND MARKETING AUTHORISATION HOLDERS 6 4.1 Description of the risk management system. 6 4.2 EU Risk Management Plan (EU-RMP) 7 4.3 Situations when an EU-RMP is required 7 4.3.1 Authorisations via the centralised procedure 8 4.3.2 Authorisations via the mutual recognition or decentralised procedure. 8 4.4 Location in the dossier 8 4.5 Safety Specification 8 4.5.1 Non-clinical 9 4.5.2 Clinical 9 4.5.2.1 Limitations of the human safety database 9 4.5.2.2 Populations not studied in the pre-authorisation phase 10 4.5.2.3 Adverse Events/Adverse Reactions 10 4.5.2.4 Identified and potential interactions including food-drug and drug-drug interactions 12 4.5.2.5 Epidemiology 12 4.5.2.6 Pharmacological class effects 12 4.5.2.7 Additional EU requirements 12 4.5.3 Summary 13 4.6 Pharmacovigilance Plan 13 4.6.1 Routine Pharmacovigilance 13 4.6.2 Additional ...
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