COVER LETTER RENEWAL CMDH
Once the translations are received from the MAH, the Agency will check if all Member States’ comments have been implemented. In case no changes to the product information are being proposed as part of the PSUR, the MAH should not include any product information within the EU regional appendix. Where the proposed changes are not based on the data submitted within the PSUR, these will not be considered and a variation will have to be submitted as appropriate to the relevant national competent authority. 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: The European Union reference date EURD corresponds to the date of the first or the earliest known date of the marketing authorisation in the EU of a medicinal product containing the active substance or combination of active substances. 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.
The MAH s will implement the required changes. For nationally authorised products NAPs , please submit your query using the following web form. This portal replaces the following mailboxes gatewaysupport ema. The list will then be amended accordingly when appropriate and published on the European medicines website. You will be able to contact the RMS throughout the procedure. Subsequently, where the procedure includes at least one CAP, the Commission will adopt a decision to the MAHs for the centrally authorised products and, as applicable, to the competent authorities of the Member States for nationally authorised products. This format is a legal requirement for both nationally authorised products and centrally authorised products.
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. In the web form you will be asked to provide your name, the name of your employer or organisation, contact details and the subject eenewal your enquiry.
Heads of Medicines Agencies: Variations
The Agency will monitor the quality of the translations, the review by the Member States and industry’s compliance with the Member States’ comments as part of the Performance Indicators.
The procedural start dates is published in the PSUR assessment timetable. In case of incomplete or incorrect data in the web form, the request may not be processed. The clinical overview submitted in the renewal application should include relevant information to support the benefit-risk re-evaluation of the medicinal product. In case no changes to the product information are being proposed as part of the PSUR, the MAH should not include any product information within the EU regional appendix.
Any amendment to the EURD list becomes effective six months after its publication. 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.
The information and data contained in the individual submissions will be assessed and reflected in the single assessment report. For CMDh position by consensus: It is important that changes proposed to the product information which are based on the submitted PSUR data are not submitted in parallel via a separate variation cmrh.
Applications for Marketing Authorisation
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.
Whilst changes become binding 6 months after cofer, 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. You should type the full details of your query in the appropriate space. PSURs are pharmacovigilance documents intended to provide an evaluation of the risk-benefit balance of a cmeh product at defined time points after its authorisation.
Use of the PSUR repository is mandatory for both centrally and nationally authorised medicines, whether covre follow the EU single assessment or a purely national assessment cmdy. 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.
There may be some delay before EMA is able to respond due to the high volume of requests and necessary processing time. Implementing variation needed, type and classification.
They, however, remain part of xover Commission Decision in the Community Registry on the Commission’s webpage. MAHs should contact the relevant Risk Management Specialist in case of such requests if there is a need for initial clarification on the process. The timelines for assessment are for up to days followed by 67 days of Commission decision making process if applicable. The changes proposed to the labelling can be based on the reference product information.
Any information included in this section, will rnewal discussed by the CMDh for nationally authorised products with the aim of agreeing on any necessary action, which will then be transmitted to MAHs either in the CMDh minutes or as a press release dependent on the issue.
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. In the absence of a reply within two days, the EMA will assume that no oral explanation is requested.
They shall be submitted by marketing authorisation holders at defined time points during the post-authorisation phase. Of note, MAHs cannot use the information and data contained in the submissions for any other purposes than those related to the concerned procedure.
Day 15 15 days after the position: The request and its grounds should be considered lettef the PRAC and the CHMP if it concerns at least letted marketing authorisation granted in accordance with the centralised procedure or the CMDh otherwise, which will either approve or deny the request. How useful was this page? CMDh Guidance on the Informal Work-Sharing procedure for follow-up for PSUSA for NAPs 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 cndh products including those authorised through the mutual recognition and decentralised procedures.
Periodic safety update reports (PSURs) | European Medicines Agency
The PSUR should focus on summary information, scientific assessment and integrated benefit-risk evaluation. Before submitting a request, EMA encourages stakeholders to carefully consult the Introductory cover note. Good quality of the translations and compliance with the Member States’ comments is required to facilitate the process. The EMA will coveg at the beginning of the procedure whether the submission of an RMP has been correctly performed in accordance to the above criteria.