European Medicines Agency - News and press release archive - Public consultation opens on the revised guideline on good distribution practice of medicinal products for human use

European Medicines Agency - News and press release archive - Public consultation opens on the revised guideline on good distribution practice of medicinal products for human use: "18/07/2011
Public consultation opens on the revised guideline on good distribution practice of medicinal products for human use

The European Commission's Directorate General for Health and Consumer Policy (DG SANCO) has launched a public consultation on the revised ‘Guideline on Good Distribution Practice of Medicinal Products for Human Use’ [http://ec.europa.eu/health/files/eudralex/vol-4/2011-07_gdpguidline_publicconsultation.pdf]. The European Medicines Agency through its GMP/GDP Inspectors Working Group worked on the revision of the guideline which was first published in 1994.

The guideline was revised to take into account developments in the storage and distribution of medicinal products in the European Union and to meet new requirements for wholesale distributors and brokers established in the new Directive 2011/62/EU on falsified medicines.

The draft guideline is of particular interest to wholesale distributors and brokers of medicinal products for human use as well as for manufacturers who distribute their own products.

Comments and suggestions are invited by 31 December 2011 and should be sent by email to: SANCO-gmp@ec.europa.eu and ADM-GMDP@ema.europa.eu using this template for comments.

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