Additional Risk Minimisation Measures for Medicinal Products in the European Union: A Review of the Implementation and Effectiveness of Measures in the United Kingdom by One Marketing Authorisation Holder-Reference-Cited by-同舟云学术

Additional Risk Minimisation Measures for Medicinal Products in the European Union: A Review of the Implementation and Effectiveness of Measures in the United Kingdom by One Marketing Authorisation Holder

Published:2017-03-29 Issue:2 Volume:31 Page:101-112
ISSN:1178-2595
Container-title:Pharmaceutical Medicine
language:en
Short-container-title:Pharm Med

Author:

Agyemang Elaine^ORCID,Bailey Lorna,Talbot John

Funder

F. Hoffmann-La Roche

Publisher

Springer Science and Business Media LLC

Subject

Pharmacology (medical),Pharmacology

Link

http://link.springer.com/content/pdf/10.1007/s40290-017-0184-8.pdf

Reference40 articles.

1. European Commission. Directive 2010/84/EU of the European parliament and of the council. 2010. Retrieved August, 22, 2014, from http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2010:348:0074:0099:EN:PDF .

2. European Commission. Regulation (EU) no 1235/2010 of the European parliament and of the council. 2010. Retrieved August, 22, 2014, from http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2010:348:0001:0016:EN:PDF .

3. European Medicines Agency Guideline on good pharmacovigilance practices Module V: risk management systems. 2012. Retrieved March, 12, 2014, from http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2012/06/WC500129134.pdf .

4. European Medicines Agency. Guideline on good pharmacovigilance practices (GVP) Module XVI, risk minimisation measures: selection of tools and effectiveness indicators. 2014. Retrieved March, 12, 2014, from http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2013/06/WC500144010.pdf .

5. European Medicines Agency. Position paper on potential medication errors in the context of benefit-risk balance and risk minimisation measures. 2013. Retrieved April, 11, 2014, from http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2013/06/WC500144096.pdf .

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