No specific template needs to be followed for the responses to the request for supplementary information RSI. Skip to main content. An agreement on the procedural details of the PSUR submission should be reached between the marketing authorisation holder and the Agency. Procedures that contain nationally authorised products NAP s. For more information on GVP modules, see Good pharmacovigilance practices. For nationally authorised products NAPs , please submit your query using the following web form.
Procedures that contain centrally authorised products CAP s. At start of the procedure, the invoice will be sent to each MAH with the relevant chargeable units calculation. Any amendment to the EURD list becomes effective six months after its publication. There may be some delay before EMA is able to respond due to the high volume of requests and necessary processing time. An agreement on the procedural details of the PSUR submission should be reached between the marketing authorisation holder and the Agency. For more information, see:. The timelines for assessment are for up to days followed by 67 days of Commission decision making process if applicable.
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. In this communication the MAH should indicate coverr they would wish to make use of the opportunity of an oral explanation to defend their position before the PRAC. 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. The request and its grounds should be considered by the PRAC and the CHMP if it concerns at least one marketing authorisation granted in accordance with the centralised procedure or the CMDh otherwise, which will either approve or deny the request.
Timeframe for submission of variation.
There may be some delay before EMA is able to respond due to the high volume of requests and necessary processing time. It should be presented as a tracked change version of each EU SmPCs and package leaflets of the products concerned and each product information should be translated into English language including the tracked changes proposed, in order to enable the EU single assessment.
For nationally authorised products NAPsplease submit your query using eema following web form. The explanatory note highlights and addresses challenges specific to the EU single assessment for nationally authorised products. The PSUR frequency as published on the EURD list for a given active substance or combination of active substances overrules the standard submission cycle i.
Please note that late submissions can no longer be accepted once the procedure has started.
In the latter case, a justification should be dover for the appropriate language s stating why certain comments are not reflected in the final texts. It should be noted that the PSUSA cut-off date continues to apply to procedures containing nationally authorised medicinal productsand indicates the next upcoming start date for relevant submission deadlines in the EURD list.
The total of chargeable units in the procedure will be identified from the Art. Day days after position The MAH s will implement the required changes. A PSUR assessment can determine if further investigations on a specific issue are needed, or if an action is necessary to protect public health coved.
If the contact details you provide are incomplete or inaccurate this may prevent the Agency from communicating with you. In the absence of a lether within two days, the EMA will assume that no oral explanation is requested The MAH of centrally authorised medicinal products should submit a clean and a tracked version of the agreed amended product information prior to the adoption of the PRAC recommendation.
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 authorisationsas cocer Procedures that contain cver authorised products NAP s Annex C: The PSUR is not the appropriate procedure for submitting final or interim study reports to the EU regulatory authorities.
Peur shall be submitted by marketing authorisation holders at defined time points during the post-authorisation phase. In case the PRAC recommends any regulatory action i. 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 share payable by each marketing authorisation will be calculated by the EMA. It is important that changes lrtter to the product information which are based on the submitted PSUR data are not submitted in parallel via a separate variation procedure.
Periodic safety update reports (PSURs)
The submission should include a cover letter containing the following formatted table template to facilitate the registration of the submission. The fee will be due to the EMA within 30 calendar days from the date of the invoice. 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. The information and data contained in the individual submissions will be assessed and reflected in the single assessment report.
Day 15 15 days after the position: Veterinary regulatory Overview Research and development Marketing authorisation Post-authorisation.
Heads of Medicines Agencies: Variations
For more information on GVP modules, see Good pharmacovigilance practices. 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.
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 list will then be amended accordingly when appropriate and published on the European medicines website. 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.