EU/445
WTO/TBT
CE European Union
  • 11 - Health care technology
2017-03-18
2017-01-20
Medicinal products for human use

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 (9 pages + Annex 3 pages, in English)

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.