EU - Draft Commission Directive supplementing Directive 2001/83/EC of the European Parliament and of the Council as regards the principles and guidelines of good manufacturing practice for medicinal products for human use This draft Commission Directive on principles and guidelines of good manufacturing practice for medicinal products for human use provides for, inter alia requirements regarding: · Personnel · Premises and equipment · Documentation · Production · Quality control · Outsourced operations · Complaints and product recall This draft Commission Directive will also repeal Directive 2003/94/EC laying down the principles and guidelines of good manufacturing practice in respect of medicinal products for human use and investigational medicinal products for human use. Good manufacturing practice for investigational medicinal products will be laid down in a new Commission Delegated Regulation. Proposed date of adoption: End of March 2017 Proposed date of entry into force: The twentieth day following publication in the Official Journal of the EU. It is currently expected that the measures will become applicable in October 2018. Final date for comments: 60 days from notification Click below to view this Proposal/Notification/Regulation :- https://members.wto.org/crnattachments/2017/TBT/EEC/17_0358_00_e.pdf https://members.wto.org/crnattachments/2017/TBT/EEC/17_0358_01_e.pdf | 
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