Single central submission now mandatory for all periodic safety update reports.
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13 Jun Single central submission now mandatory for all periodic safety update reports.

Posted at 20:33h in Pharmacovigilance by

Starting from 13 June 2016 onwards the transitional rules for submission of PSURs to the National Competent Authorities are no longer applicable. MAHs are now required to submit PSURs directly to the PSUR repository using the eSubmission Gateway. Except PSURs for products under Article 58 of Regulation (EC) No 726/2004, all other PSURs are affected by the direct PSUR repository submission irrespective whether they are for centrally or nationally authorised medicinal products and whether they follow the EU single assessment or purely national PSUR procedure. Details are provided in EMA Announcement on the mandatory use of the PSUR repository. In line with that the Bulgarian Drug Agency announced that they will no longer accept local submission of PSURs. The Romanian National Agency for Medicines and Medical Devices also published press release regarding PSUR submission.