Impact of Changing Regulations and the Dynamic Nature of European Risk Management Plans for Human Medicines on the Lifecycle of Safety Concerns-Reference-Cited by-同舟云学术

Impact of Changing Regulations and the Dynamic Nature of European Risk Management Plans for Human Medicines on the Lifecycle of Safety Concerns

Published:2022-01-31 Issue:1 Volume:36 Page:33-46
ISSN:1178-2595
Container-title:Pharmaceutical Medicine
language:en
Short-container-title:Pharm Med

Author:

Holm Julia Elvira Johanna,Ruppert Jan Gustav,Ramsden Samuel David

Publisher

Springer Science and Business Media LLC

Subject

Pharmacology (medical),Pharmacology

Link

https://link.springer.com/content/pdf/10.1007/s40290-021-00414-8.pdf

Reference18 articles.

1. European Commission (EC). Directive 2001/82/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to veterinary medicinal products. https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32001L0082&from=EN. Accessed 9 Feb 2021.

2. European Commission (EC). Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Union procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency. https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02004R0726-20190330. Accessed 10 Feb 2021.

3. European Medicines Agency (EMA). EMEA/CHMP/96268/2005. Committee for medicinal products for human use (CHMP) guideline on risk management systems for medicinal products for human use. (2005).

4. European Medicines Agency (EMA). EMEA/192632/2006. Annex C: template for EU risk management plan (EU–RMP). https://eudravigilance.ema.europa.eu/human/docs/19263206en.pdf. Accessed 5 Feb 2021.

5. European Commission (EC). VOLUME 9A—guidelines on pharmacovigilance for medicinal products for human use. 2008. https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-9/pdf/vol9a_09-2008_en.pdf. Accessed 9 Feb 2021.

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