Author (Corporate) | European Medicines Agency |
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Series Title | Announcement |
Series Details | 1.8.08 |
Publication Date | August 2008 |
Content Type | News |
The European Medicines Agency (EMEA), in August 2008, issued a reminder to manufacturers, companies and hospitals having advanced therapy medicinal products legally on the market in the European Union that these products must be authorised in accordance with EMEA marketing-authorisation procedures, in order to comply with Regulation (EC) No 1394/2007 on advanced therapy medicinal products. Holders of these products should contact the Agency as soon as possible to discuss the data package to be submitted for this authorisation procedure. |
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Source Link | Link to Main Source http://www.emea.europa.eu/pdfs/human/genetherapy/32614508en.pdf |
Subject Categories | Business and Industry, Health |
Countries / Regions | Europe |