Tema Sinergie

Company

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IEL Conference

June 21st-22nd 2017, Birmingham - UK

SNMMI Annual Meeting - BOOTH #339

June 10th-14th 2017, Denver CO - USA

Newsletter

Company

Regulatory aspects

 Normative di riferimento:

  • Direttiva 91/356/EEC del 13/06/1991 – Principles and guidelines of good manufacturing practice for medicinal products for human use 
  • Direttiva 2001/83/CE del 6 novembre 2001 recante un codice comunitario relativo ai medicinali per uso umano
  • Direttiva 2003/94/CE del 08/10/2003 – Principles and guidelines of good manufacturing practice for medicinal products and investigational medicinal products for human use.
  • Pharmaceutical Legislation - Medicinal products for human and veterinary use - Volume 4, Good manufacturing practice – European Commission, 1997.
  • Volume 4 of "The rules governing medicinal products in the European Union" contains guidance for the interpretation of the principles and guidelines of good manufacturing practices for medicinal products for human and veterinary use laid down in Commission Directives 91/356/EEC, as amended by Directive 2003/94/EC, and 91/412/EEC respectively.
  • Direttiva 93/42/ CE 14 giugno 1993 sui Dispositivi Medici