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Single, central platform now mandatory for all periodic safety update reports

PSUR repository facilitates information exchange on the safety of human medicines authorised in the EU

As of 13 June 2016, all periodic safety update reports (PSURs) for human medicines authorised in the European Union (EU) must be submitted to the PSUR repository, which has been developed by the European Medicines Agency (EMA) in close collaboration with EU Member States and the industry.

More information on this is included in the hyperlink below:

Single, central platform now mandatory for all periodic safety update reports (10/06/2016)

Due to the complicated situation of increased risk of COVID-19 and the declared State of emergency in the Republic of Bulgaria, many additional factors will influence the conduct of clinical trials in sites on the territory of the country - limited access to medical establishments, limited resources etc.

The patients’ safety and health is a main priority and the changes in the conduct of clinical trials must be based on a detailed risk assessment.

Tags:
Information for companies, Medical devices

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