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European Periodic Safety Update Reports (PSUR) Synchronisation Project - Extension of the scheme

Following previous articles in MAIL regarding the new European Periodic Safety Update Reports (PSUR) work sharing project we would like to highlight to marketing authorisation (MA) holders that the products covered by this scheme have been expanded to include products authorised prior to 1976. A draft of the extended list has been published on the Heads of Agencies website (external link). We strongly recommend that all MA holders check this list carefully to ensure all actives in their portfolios are covered. Details of how to send additional proposals are given on the Heads of Agency website.

The deadline for sending comments is 30 May 2008. Herbals, homeopathics and biologicals such as vaccines and blood products are still excluded from the scheme.

 

Page last modified: 23 May 2008