The PSUR should focus on summary information, scientific assessment and integrated benefit-risk evaluation. Depending on the date of the EC decision on the revocation or withdrawal, or the date of expiry of the marketing authorization in case of non- renewal , marketing authorisation holders may still be required to submit a PSUR: Annex I scientific conclusions and grounds for variation to the terms of the marketing authorisations Annex II amendments to the product information of the nationally authorised medicinal products Annex III conditions to the marketing authorisations , as applicable Procedures that contain nationally authorised products NAP s Annex C: National competent authorities can also request PSUR for generic medicinal products at any time on the grounds detailed in Article c 2 of the Directive. PSUR repository mandatory use: Marketing authorisation holders are not required to systematically include listings of individual cases, including case narratives, in the PSUR. However, they shall provide case narratives in the relevant risk evaluation section of the PSUR where integral to the scientific analysis of a signal or safety concern in the relevant risk evaluation section.
There may be some delay before EMA is able to respond due to the high volume of requests and necessary processing time. For centrally authorised products interim results not impacting on the product information or on the condition as stated in the Annex II of the marketing authorisation can be submitted as a post-authorisation measure PAM as described in question How and to whom shall I submit my PAM data see Post-authorisation measures: 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. Whilst changes become binding 6 months after publication, there might exceptionally be situations where PSUR submissions are necessary prior to the new frequency taking effect and this will be indicated in the EURD list as well. An agreement on the procedural details of the PSUR submission should be reached between the marketing authorisation holder and the Agency.
The Agency uses this information to support the analysis of data, regulatory activities and communication. In this communication the MAH should indicate whether they would wish to make use of the opportunity of an oral explanation to defend their position before the PRAC.
If the contact details you provide are incomplete or inaccurate this may cober the Agency from communicating with you. Within the PSUR, the marketing authorisation holder is required to consider the pzur of the data and evaluations presented within the report, on the marketing authorisation. The Agency aims to respond to your query within 5 working days. Guideline on good pharmacovigilance practices GVP: Start of the procedure according to the published timetable.
The procedural start dates is published in the PSUR assessment timetable. They, however, remain part of the Commission Decision in the Community Registry on the Commission’s webpage. The share payable by each lettr authorisation will be calculated by the EMA. Skip to main content. In this case no stand-alone RMP variation is necessary.
In lether web form you will be asked to provide your name, the name of your employer or organisation, contact details and the subject of your enquiry. For more details on how to submit amendments to the list, please refer to the EURD list cover note sections 2 and 5. Annex I – Definitions.
Use of the PSUR repository is mandatory for both centrally and nationally authorised medicines, whether they follow the EU single assessment or a purely national assessment procedure. The MAH s will implement the required changes.
Periodic safety update reports (PSURs)
However as the reference product information might be different for the various EU product informationit is essential that the MAH considers the proposed changes for the reference product information in the context of the different EU product information for the products covered by the submitted PSUR. The parallel importer should also inform the MAH immediately.
PSURs and ldtter related submissions using the existing file naming conventions are no longer possible. Timeframe for submission of variation. The list will then be amended accordingly when appropriate and published on psu European medicines website.
Petter more information on GVP modules, see Good pharmacovigilance practices. For more information, see the questions-and-answers below and Periodic safety update report single assessments.
Periodic safety update reports (PSURs) | European Medicines Agency
To further facilitate the check and assessment, the MAH should present clean and tracked changes Word versions of the RMP in the submission. In cases where the wording has to be adapted, a type IB under category C. Of note, MAHs cannot use the information and data contained in the submissions for any other purposes than those related to the concerned procedure.
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. Day 1 — 14 1 to 14 days after position: Good quality of the translations and compliance with the Member States’ comments is required to facilitate the process.
The submission should include a cover letter containing the following formatted table template to facilitate the registration of the submission. A PSUR assessment can determine if further investigations on a specific issue are needed, or if an action is necessary to protect public health e.
The objective of the PSUR is to present a comprehensive and critical analysis of the risk-benefit balance of the product, taking into account new or emerging safety information in the context of cumulative information on risk and benefits. The timelines for assessment are for up to days followed by 67 days of Commission decision making process if applicable.
By analogy to the implementation of referral procedures, the respective variations for the NAPs have to be submitted to the relevant NCA within 10 days after publication of the Commission Decision on the EC website. For purely nationally authorised medicinal productscontaining substances or combination of actives substances not included in the EURD listfor which no PSUSA procedure has been established, the assessment of the PSURs will remain at national level.
These should take into account all EU authorised indications for products containing that active substance or combination of active substances.