Legal framework for pharmacovigilance inspection
Author:
Affiliation:
1. Agency for drugs and medical devices, Blvd. Ss. Cyril and Methodius 54, 1000 Skopje, R.N. Macedonia
2. Pharmaceutical Faculty, University “SS. Cyril and Methodius”, Blvd. Mother Theresa 47, 1000 Skopje, RN Macedonia
Publisher
Macedonian Pharmaceutical Association
Subject
General Medicine
Link
https://bulletin.mfd.org.mk/volumes/Volume%2068_3/68_3_243.pdf
Reference7 articles.
1. FDA’s E2E Pharmacovigilance Planning; FDA Guidance for Industry: GPV and pharmacoepidemiologic Assessment. March 2005; Guidinig principles for the international pharmacovigilance cluster
2. Directive 2010/84/EU of the European Parliament and of the Council of 15 December 2010. Regulation (EU) 1235/2010 of the European Parliament and of the Council of 15 December 2010.Law on medicines and medical devices Act.Official Gazette No. 106/07, 05/09/2007 (https://malmed.gov.mk).
3. Guideline on good pharmacovigilance practices (GVP) Module III – Pharmacovigilance inspevtions (Rev 1), 16/09/2014.
4. Guidelines for Conducting Pharmacovigilance Inspections Union procedure on the preparation, conduct andreporting of EU pharmacovigilance inspections (01/06/2014)
5. Union procedure on the coordination of EU pharmacovigilance inspection (01/06/2014)
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