PSURs (Periodic safety update reports)
PSURs – Periodic safety update reports
The PSUR (Periodic Safety Update Report) is a periodic evaluation of the risk-benefit balance of a medicinal product and provides an analysis of its safety and efficacy profiles throughout the medicine life cycle. The submission of a PSUR for a medicinal product to the competent authorities is regulated bi Law and shall follow relevant procedures and timelines established at European level in accordance with Community rules.
Submission of the PSUR for a medicine
The PSUR shall be sumbitted for all approved medicinal products unless they are covered by the derogation given in Directive 2001/83, Article 107b.3, regardless of the marketing status of the product.
The presentation of PSURs does not exempt the MAH from the obligation to report any important new information related to the safety and efficacy of the product, as required by current legislation and good pharmacovigilance practices.
The format and content of the PSUR are described in the GVP Module VII published on the EMA website.
When to submit the PSUR
The MAH shall check the EURD list to verify the DLP and the submission date of the PSUR for the active substance of the medicinal product. In particular, MAHs of products authorised under Articles 10(1), 10a, 14 and 16a shall check the list to verify whether the PSUR is required also for these types of products and act accordingly.