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PSURs: FAQ s and Submission Form – German and English Versions

The BfArM has published modified FAQs relating to PSUR submission. Of particular importance is the information about electronic submissions and changes in the regulation of transmitting comments on national PSURs. From now on, please use the new forms for PSUR submission and prolongation of submission intervals. Do not forget to add the list of products to each submitted PSUR.

FAQs about PSUR submissions

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