New guidelines on good distribution practice for APIs
The European Commission has published new guidelines on good distribution practice (GDP) for active substances (API) for medicinal products for human use.
Distributors of active substances for medicinal products for human use should follow these guidelines as of 21 September 2015.
Distribution of active substances comprise activities consisting of procuring, importing, holding, supplying or exporting active substances.
Active substances intended for the manufacture of veterinary medicines are exempted from these guidelines.