Measuring the impact of the 2012 European pharmacovigilance legislation on additional risk minimization measures-Reference-Cited by-同舟云学术

Measuring the impact of the 2012 European pharmacovigilance legislation on additional risk minimization measures

Published:2018-08-22 Issue:10 Volume:17 Page:975-982
ISSN:1474-0338
Container-title:Expert Opinion on Drug Safety
language:en
Short-container-title:Expert Opinion on Drug Safety

Author:

Francisca Reynold D. C.¹²^ORCID,Zomerdijk Inge M.¹²,Sturkenboom Miriam C. J. M.¹³,Straus Sabine M. J. M.¹²

Affiliation:

1. Department of Medical Informatics, Erasmus Medical Centre, Rotterdam, The Netherlands

2. Department of Pharmacovigilance, Medicines Evaluation Board, Utrecht, The Netherlands

3. Julius Global Health, University Medical Centre Utrecht, Utrecht, The Netherlands

Publisher

Informa UK Limited

Subject

Pharmacology (medical),General Medicine

Link

https://www.tandfonline.com/doi/pdf/10.1080/14740338.2018.1512579

Reference25 articles.

1. Guideline on good pharmacovigilance practices (GVP): module V - risk management systems (Rev 1). 2014. [cited 2015 Aug 4]. Available at: http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/document_listing/document_listing_000345.jsp&mid=WC0b01ac058058f32c

2. Regulation (EC) No 726/2004 of the European parliament and of the council of March 2004 laying down community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European medicines agency. 2013; [cited 2015 Aug 4]. Available at: https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-1/reg_2004_726/reg_2004_726_en.pdf

3. Directive 2001/83/EC of the European parliament and of the council of 6 November 2001 on the community code relating to medicinal products for human use. 2012; [cited 2015 Aug 4]. Available at: https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-1/dir_2001_83_consol_2012/dir_2001_83_cons_2012_en.pdf

4. Risk Minimization Activities of Centrally Authorized Products in the EU

5. Guideline on good pharmacovigilance practices (GVP): module XVI - risk minimisation measures: selection of tools and effectiveness indicators (Rev 1). 2014. [cited 2015 Aug 4]. Available at: http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/document_listing/document_listing_000345.jsp&mid=WC0b01ac058058f32c

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