Updated list with active substances participating in PSUR Worksharing
Friday, July 03, 2009
The list at Heads of Medicines Agencies is now updated with the latest information and additional specification.
The list makes it easy to follow the procedure for the active substance and present when it is time for the next submission of the Periodic Safety Update Report (PSUR). (See link at right)
When the Marketing Authorisation Holder (MAH) plans the submission of PSUR to the Medical Products Agency it is recommended to use the list. When the list is updated certain information, for instance change of DLP; can change and MAH needs to pay attention if any change has been made for a specific active substance. The list is planned to be updated 4 times per year
Observera publiceringsdatumet på nyheten. Läkemedelsverket uppdaterar inte nyheter.