Day days after position The MAH s will implement the required changes. In the absence of a reply within two days, the EMA will assume that no oral explanation is requested. The regulatory activity ‘PSUR’ can only be used for the ‘initial’ PSUR submission due to the built-in business rules linking to the submission deadline. Submission requirements and EU reference dates: In case of incomplete or incorrect data in the web form, the request may not be processed. For CMDh position by consensus: You will be able to contact the RMS throughout the procedure.

The submission should include a cover letter containing the following formatted table template to facilitate the registration of the submission. Day days after position The MAH s will implement the required changes. In case of CMDh position by consensus, Member States may perform a voluntary linguistic review in the translation process, therefore the following timelines apply: 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. 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.

Periodic safety update dover 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 parallel importer should also inform the MAH immediately. The request covre 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.

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.

Heads of Medicines Agencies: Variations

This aims to harmonise and strengthen benefit-risk review of medicines across the European Economic Area. Once the translations are received from the MAH, the Agency will check coger all Member States’ comments have been implemented. Before submitting a request, EMA encourages stakeholders to carefully consult the Introductory cover note. It addresses specific challenges in the EU single assessment procedure for nationally authorised productsbut the issues may also pusr to centrally authorised products: Start of the procedure according to the published timetable.


Periodic safety update reports (PSURs)

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.

Implementing variation needed, type and classification. For CAPs outside the procedure e.

cover letter psur ema

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- renewalmarketing authorisation holders may still be required to submit a PSUR:.

For more information on the EURD list and answers to frequently-asked-questions, see the following document: 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.

Guideline on good pharmacovigilance practices GVP: 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 use of key word ‘PSUR’ as a minimum in ems subject line will help the Agency allocate your query to the correct person.

cover letter psur ema

The MAH is expected to provide, as applicable, by Day 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: This can result in having to submit a large number of sets of tracked change product information with the additional burden of providing translations.

It should be presented as a tracked change version of each EU SmPCs and package dma of the products concerned and each product information should be translated into English language including the tracked changes proposed, in order ltter enable the EU single assessment. Following receipt of the final compiled translations, the Commission will start the day Standing Committee consultation, addressing only legal and public health matters which means in principle no further linguistic review.


How useful was this page? 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 submission requirements for responses to requests for supplementary information are the same as those for the submission of the PSURs. In case the PRAC recommends any regulatory action i.

– Cambridge Regulatory Services

MAHs or national competent authorities can request the inclusion of the fixed combination in pwur EURD list for reasons related to public health, in order to avoid duplication of assessment or in order to achieve international harmonisation. However, the parallel importer will not become party to the PSUR procedure and will not receive a copy of the assessment report and outcome documentation as a MAH would.

In cases where lettter wording has to be adapted, a type IB under category C. The EURD covee is a living document, meaning that it can be amended whenever considered necessary by the PRACCHMP or CMDh in response to the emergence of relevant new safety information, newly authorised substances or requests from the marketing authorisation holders.

PSURs and any related submissions using the existing file naming conventions are no longer possible.


Timeframe for submission of variation. For nationally authorised productsinterim results, if requested, need to be submitted to the relevant competent authority unless specified otherwise.

The frequency of submission shall be in accordance with the conditions specified in the marketing authorisation MAor otherwise according to the standard submission schedule of PSURs i. Of note, Ckver cannot use the information and data contained in the submissions for any vover purposes than those related to the concerned procedure. The clinical overview submitted in the renewal application should include relevant information to support the benefit-risk re-evaluation of the medicinal product.