Start of European registration of PSURs

All Periodic Safety Update Reports (PSURS) for centrally and nationally authorized medicinal products in Europe must be submitted via the PSUR Repository as of June 13, 2016.

The PSUR Repository is a single, central platform to be used by all medicines regulatory authorities and pharmaceutical companies in the European Union to exchange information about the PSUR of medicinal products. The PSUR Repository covers only medicinal products for human use.

Consequently, marketing authorization holders must use the PSUR Repository for all PSUR submissions, with the exception of PSURs for products authorised on the basis of Article 58. When a PSUR is not sent to the Repository, the marketing authorisation holder does not comply with the legal obligation to submit a PSUR.