FDA conceptrichtlijn voor industrie over traceren medicijnen

29 oktober 2014

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry.
FDA is issuing these questions and answers to assist industry and State governments in understanding the effects of section 585 (Uniform National Policy) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) added by Title II of the Drug Quality and Security Act (DQSA), which was enacted on November 27, 2013, on State product tracing requirements and on standards, requirements, and regulations with respect to wholesale distributor and third-party logistics provider (3PL) licensing. Title II is also referred to as the Drug Supply Chain Security Act (Federal Register, 8 oktober 2014).
Klik hier voor de aankondiging in het federale register.
Klik hier om de voorgestelde richtlijn te downloaden (154 kB).
Traceerbaarheid is een van de onderwerpen die aan bod komt tijdens de online NVC-module Safety and pharmaceutical packaging.

Dit bericht is ook opgenomen in ons maandelijkse overzicht, de NVC Members-only Update. Heeft u vragen, neem dan contact met ons op via e-mail of bel: +31-(0)182-512411.