Wednesday, March 13, 2013

New EU GDP Guidelines Published

Quality and integrity of medicinal products are key factors that must be maintained during the entire supply chain from the manufacturer to the patient. The European Commission revised the guidelines that lay down appropriate tools to assist wholesale distributors in conducting their activities and to prevent falsified medicines from entering the legal supply chain.

Wholesale distribution of medicinal products is defined as "all activities consisting of procuring, holding, supplying or exporting medicinal products, apart from supplying medicinal products to the public. Such activities are carried out with manufacturers or their depositories, importers, other wholesale distributors or with pharmacists and persons authorized or entitled to supply medicinal products to the public in the Member State concerned."

The revised EU GDPs, Good Distribution Practices, become effective September 8, 2013.
Guidelines of 7 March 2013 on Good Distribution Practice of Medicinal Products for Human Use (2013/C 68/01)

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