EU – Draft Commission Delegated Regulation supplementing Regulation (EU) No 536/2014 of the European Parliament and Council by specifying principles of and guidelines for good manufacturing practice for investigational medicinal products for human use and arrangements for inspections This draft Delegated Regulation laying down principles and guidelines of good manufacturing practice for investigational medicinal products for human use and arrangements for inspections, provides for, inter alia: · Requirements as regards personnel, premises and equipment, documentation, production, quality control, responsibilities of the qualified person, outsourced operations, complaints, product recall and emergency unblinding · Inspection arrangements, e.g. unannounced inspections, requirement to draft an inspection report, granting of GMP certificates and submission to the Eudra GMDP of such certificates and mutual recognition of inspection conclusions · Rules on conflict of interest and impartiality for GMP inspectors · Inspectors' empowerment and competence. 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 measure will become applicable in October 2018. Final date for comments: 60 days from notification Click below Link to view this Prposal/ Notification / Regulation :- https://members.wto.org/crnattachments/2017/TBT/EEC/17_0357_00_e.pdf https://members.wto.org/crnattachments/2017/TBT/EEC/17_0357_01_e.pdf | 
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