The project involving synchronisation of Periodic Safety Update Report (PSUR) submission for medicinal products authorised through the decentralised, mutual recognition and national procedures is now running.
The project is intended to enhance the safety of medicinal products and ensure that PSURs are synchronised throughout the EU when submitted to the authorities in the individual country. We therefore strongly recommend pharmaceutical companies to submit PSURs according to the new scheme for products comprised by the project.
Simultaneous PSUR submission throughout the EU
Every three years, the pharmaceutical companies submit PSURs simultaneously throughout the EU for all medicinal products containing the same active substance. The aim of the project is to:
- enhance the quality of Periodic Safety Update Reports
- harmonise the assessment of medicinal products
- harmonise product information, including package leaflets, for all products containing the same active substance
- simplify the procedure for PSUR preparation and submission to the benefit of pharmaceutical companies.
The box to the right links to the main page of the PSUR synchronisation project, which lists all updated, relevant documents about the project. The page lists various documents, including a Q&A document, a complete list of all EU harmonised birthdates (EU HBD) for each active substance with corresponding Data Lock Point (DLP) and PSUR Reference Member State (P-RMS) as well as an additional list of active substances that are planned to be included in the project. Both lists are updated as new EU HBDs and P-RMSs are added.
Please address questions concerning the practical implementation to fos@dkma.dk.
Furthermore, we strongly encourage companies to submit PSURs only on CD-ROM.
