For nationally authorised products , interim results, if requested, need to be submitted to the relevant competent authority unless specified otherwise. If a translation is considered not to be of an acceptable quality, the Member State concerned will inform the MAH and the Agency within 3 days of receipt of the translation. Within the PSUR, the marketing authorisation holder is required to consider the impact of the data and evaluations presented within the report, on the marketing authorisation. This should be clearly discussed in both the conclusions and actions section of the body of the PSUR as well as in the EU regional appendix. The MAH s will implement the required changes.
For purely nationally authorised medicinal products , containing substances or combination of actives substances not included in the EURD list , for which no PSUSA procedure has been established, the assessment of the PSURs will remain at national level. The changes related to the use of ‘submission type’ and the new ‘submission unit type’ will be introduced to the PSUR repository in the next release of the PSUR Repository currently planned for July The Agency uses this information to support the analysis of data, regulatory activities and communication. If the date is after the submission deadline specified in the EURD list , submission is mandatory irrespective of whether the date is before or after the start date of the procedure. The data presented in the submissions should be intended exclusively for the purposes of the concerned procedure. Once the translations are received from the MAH, the Agency will check if all Member States’ comments have been implemented.
No specific template needs to be followed for the responses to the request for supplementary information RSI. This should be clearly discussed in both the conclusions and actions section of the body of the PSUR as well as in the EU regional appendix. Annex I scientific conclusions and grounds for variation to the terms of the marketing authorisations Annex II amendments to the product information of the covre authorised medicinal products Annex III conditions to the marketing authorisationsas applicable Procedures that contain nationally authorised products NAP s Annex C: For nationally authorised medicinal products i.
Periodic safety update reports (PSURs)
The PSUR assessment under a PSUSA procedure is as follows, regardless whether it refers to one or more centrally authorised medicinal productscoveer mix of centrally authorised medicinal products and nationally authorised productsor nationally authorised products only. For more information, see:.
The official contact person for the PSUR procedure is the one provided in the xml delivery file. Before submitting a request, EMA encourages stakeholders to carefully consult the Introductory cover note. Any amendment to the Lettfr list becomes effective six months after its publication.
For CMDh position by consensus: CMDh Guidance on the Informal Work-Sharing procedure for follow-up for PSUSA for NAPs Amendments to the Covee, labelling and package leaflet as a result of the PSUR assessment are implemented without subsequent variation submission for centrally authorised products and through the appropriate variation at national level for nationally authorised products including those authorised through the mutual recognition and decentralised procedures.
Submission requirements and EU reference dates: However PSURs should be submitted as specified in the conditions of the marketing authorisation for the combination product if anyor otherwise according to the standard submission cycle i.
Periodic safety update reports are pharmacovigilance documents intended to provide a safety update resulting in an evaluation of the impact of the reports on the risk-benefit balance of a medicinal product.
In case of a CMDh position by consensus pusr, the Agency will compile the Annexes in all languages, send the final copies to the Member States and, where applicable, the full set of Annexes will be published on the EMA website. This format is a legal requirement for both nationally authorised products and centrally authorised products. Please note that late submissions can no longer be accepted once the procedure has started.
Where a marketing authorisation is withdrawn, revoked or not renewed, the former marketing authorisation holder is encouraged to continue to collect spontaneous reports of suspected adverse reactions occurring in the EU see GVP Module VI to, for example, facilitate review of delayed onset adverse reactions or of retrospectively notified cases of adverse reactions. The share payable by each marketing authorisation will be calculated by the EMA. To further facilitate the check and assessment, the MAH should present clean and tracked changes Word versions of the RMP in ccover submission.
For more information, see: In the latter case, a justification should be provided for the appropriate language s stating why certain comments are not reflected in the final texts.
PSUR repository mandatory use: For generic products or letted not directly involved in the PSUSA procedure itself, the changes have to be submitted via a variation procedure according to the timelines indicated in the table below. For more information, see the questions-and-answers below and Periodic safety update report single assessments.
Heads of Medicines Agencies: Variations
The parallel importer should also inform the MAH immediately. If the data contained in the PSUR contribute meaningfully to the scientific assessment, these data should be included in the scope of the PSUR procedure. If a translation is considered not to be of an acceptable quality, the Member State lether will inform the MAH and the Agency within 3 days of receipt of the translation. Do not leave sections out, do not update the Annex III, e.
Veterinary regulatory Overview Research and development Marketing authorisation Post-authorisation.
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Periodic safety update reports (PSURs) | European Medicines Agency
The Agency uses this information to support the analysis of data, regulatory activities and communication. Such information and data will not be redacted from the single assessment report with respect to individual products prior to sharing them with all concerned MAHs.
Amendments to the SmPC, labelling and package leaflet as a result of the PSUR assessment are implemented without subsequent variation submission for centrally authorised products and through the appropriate variation at national level for nationally authorised products including those authorised through the mutual recognition and decentralised procedures.
The clinical overview submitted in the renewal application should include relevant information to support the benefit-risk re-evaluation of the medicinal product. This will, where appropriate, allow one single assessment of PSURs for products containing the same active substance.