EMEA announcement to manufacturers, companies and hospitals having advanced therapy medicinal products legally on the Community market in accordance with national or Community legislation

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.