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In the March issue of Prescrire International: Revision of European pharmaceuticals legislation

FREE DOWNLOAD Prescrire has responded to a public consultation on a planned revision of Directive 2001/83 "on the Community code relating to medicinal products" and Regulation 726/2004 "laying down Community procedures for the authorisation and supervision of medicinal products (...) and establishing a European Medicines Agency".
Full text available for free download.

Summary of Prescrire's response to the consultation

  • Prescrire reminded the Commission of the need for robust evidence before marketing authorisations are granted, based on double-­blind randomised comparative clinical trials.
     
  • As regards security of supply, Prescrire stressed the need to remind marketing authorisation holders of their precise legal obligations.
     
  • Prescrire also encouraged the Commission to examine a number of topics not addressed in the roadmap, especially how to:
    • manage and improve medication safety, including the safety of drugs already on the market
    • ensure affordability and sustainable access to drugs
    • make the European Medicines Agency (EMA) more transparent and independent.

©Prescrire 1 March 2022

Source: "Revision of European pharmaceuticals legislation" Prescrire International 2022; 31 (235): 83. Free.

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