MAHs should translate all relevant Annexes for each procedure. This format is a legal requirement for both nationally authorised products and centrally authorised products. 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 changes proposed to the labelling can be based on the reference product information. For more information on the EURD list and answers to frequently-asked-questions, see the following document: 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. In the absence of a reply 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.
Good quality of the translations and compliance with the Member States’ comments is required to facilitate the process. For generic products or others 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. You should type the full details of your query in the appropriate space. The frequency of submission shall be in accordance with the conditions specified in the marketing authorisation MA , or otherwise according to the standard submission schedule of PSURs i. The PSUR should focus on summary information, scientific assessment and integrated benefit-risk evaluation. Procedures that contain centrally authorised products CAP s.
Reference SME declaration Data submission for authorised medicines. The share payable by each marketing authorisation will be calculated by the EMA. For the submission of responses to the PSUR Repository, the xml delivery file is filled in the same way as the original PSUR submission apart from the selection of ‘response’ as a regulatory activity submission unit.
Any cdmh to the EURD list becomes effective six months after its publication.
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.
In case of incomplete or incorrect data in the web form, the request may not ckver processed. The Renesal list 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. If the above does not apply, the updated RMP should be reneqal as a stand-alone variation.
Start of the procedure according to the published timetable. Of note, MAHs cannot use the information and data contained in the submissions for any other purposes than those related to the concerned procedure.
Heads of Medicines Agencies: Renewals
Before submitting a request, EMA encourages stakeholders to carefully consult the Introductory cover note. 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.
In case of a CMDh position by consensusthe Agency will compile the Annexes in all languages, send the final copies to the Member States and, where applicable, the full set of Fenewal will be published on the EMA website. The EMA has published further guidance on how the fees are calculated and collected.
Regarding centrally authorised productsthe marketing status should also be provided as a stand-alone report through the relevant mailbox and using the dedicated template as indicated in the EMA Post-authorisation Guidance on ‘marketing and cessation notification’ — What is the reporting format to the agency and to whom to report.
You will be able to contact the RMS throughout the procedure. The MAH s will implement the required changes. Submission requirements and EU reference dates: The EURD list facilitates the harmonisation of DLPs and frequency of submission of PSURs for medicinal products containing the same active substance or the same combination of active substances subject to different marketing authorisationsauthorised in more than one Member State. 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.
The submission should include a cover letter containing the following formatted table template to facilitate the registration of the submission. For more details on how to submit amendments to the list, please refer to the EURD list cover note sections 2 and 5.
Unless otherwise requested by competent authorities, the marketing authorisation holder shall prepare a single PSUR for all its medicinal products containing the same active substance with information covering all the authorised indicationsroute of administrationdosage forms and dosing regiments, irrespective of whether authorised under different names and through separate procedures.
Standards of translation of Annexes The structure of the English Annexes has to be strictly followed and should be exactly translated as per the adopted English version i.
How useful was this page? The PSUR assessment under a PSUSA procedure is as follows, regardless whether it refers to one or more centrally authorised medicinal productsa mix of centrally authorised medicinal products and nationally authorised productsor nationally authorised products only. 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.
This portal improves the efficiency of the technical support by allowing users to report issues, track progress of their queries and obtain answers to frequently asked questions.
Applications for Marketing Authorisation
PSURs of centrally authorised product s ; PSURs of any mix of centrally authorised products and nationally authorised products including through the cndh recognition and decentralised procedures ; PSURs of nationally authorised products.
Amendments to the SmPC, labelling coevr 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.
An advice note will be generated at the data lock point DLP date and sent accordingly to the relevant QPPVs in order to ensure the accurate identification of the chargeable units petter the products involved in the procedure. A revised timetable will then be prepared.
This should be clearly discussed in ldtter the conclusions and actions section of the body of the PSUR as well as in the EU regional appendix. 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. Guideline on good pharmacovigilance practices GVP: