This page lists questions that marketing-authorisation holders MAHs may have on worksharing. Human regulatory Overview Research and development Marketing authorisation Post-authorisation Herbal products. Skip to main content. Revised topics are marked ‘New’ or ‘Rev. 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:
Periodic safety update reports PSURs. The explanatory note will form the basis of the upcoming revision of GPV VII; this update, once finalised, will therefore supersede this guidance document. MAHs or national competent authorities can request the inclusion of the fixed combination in the EURD list for reasons related to public health, in order to avoid duplication of assessment or in order to achieve international harmonisation. It should be noted that the PSUSA cut-off date continues to apply to procedures containing nationally authorised medicinal products , and indicates the next upcoming start date for relevant submission deadlines in the EURD list. Where at least one of the concerned marketing authorisations has been authorised via the centralised procedure , the Agency will be the ‘reference authority’. A PDF version of the entire post-authorisation guidance is available:
For more information, see:. 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.
Applications for Marketing Authorisation
For nationally authorised products NAPsplease submit your query using the following web form. 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.
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. The list overrules the ‘standard’ PSUR submission cycle and any conditions related to the frequency of PSUR submission included in a marketing authorisation. Marketing Authorisation Holders are advised to submit such variations as usual.
The PSUR is not the appropriate procedure for submitting final or interim study reports to the EU regulatory authorities. If the MAH requests that the Committee consult a scientific advisory group in connection with the re-examinationthe applicant should inform the CHMP as soon as possible. Such opinions will also list any variations e.
This applies to all applications for human medicines. Following an expression of interest and based on a rota system, the Chair of the Committee for Medicinal Products for Human Use CHMP will appoint a rapporteur and co-rapporteur when the application includes a new indication for the procedure.
Day days after renewsl The MAH s will implement the required changes.
For nationally authorised productsinterim results, if requested, need to be submitted to the relevant competent authority unless specified otherwise.
An automated acknowledgement email is sent from the system confirming whether the submission has passed the relevant technical validation criteria and whether it tfmplate been uploaded to the Agency’s review tool and made available via the Common Repository. MAHs or national competent authorities can request the inclusion of the fixed combination in the EURD list for reasons related to public health, in order to avoid duplication of assessment or in order to achieve international harmonisation.
These questions and answers have been legter for guidance only and should be read in conjunction with the rules governing medicinal products in the European Union, volume 2, notice to applicants. For CAPs outside the procedure e. 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.
Worksharing: questions and answers | European Medicines Agency
References The linguistic review process of product information in the centralised procedure — Human. The share payable by each marketing authorisation will be calculated by the EMA. Procedures that contain nationally authorised products NAP s. If nationally authorised medicinal products are part of the worksharing procedure, the MAH should also include a confirmation that the worksharing applications have been submitted to all Member States where the products concerned are authorised and that the relevant national fees have been paid.
This is a legally binding requirement from the EU pharmaceutical legislation. Proposal for combination use affecting both MAs.
Heads of Medicines Agencies: Renewals
PSUR repository mandatory use: In such case, only the amended parts of the SmPC and package leaflet should be provided in track changes and in English language under the EU regional appendix. Worksharing procedure for type-II variations. How useful was this page? This will allow all the involved Parties The Agency, MSs and Committee Members to receive the full data for the worksharing application. Please refer to the guideline on the processing of renewals in the centralised procedure.
From 1 Marchthe use of the eSubmission Gateway or ckdh client is mandatory for all electronic Common Technical Document eCTD submissions through the centralised procedure. Article 23 1a a provides for a two-month timeframe for amending the decision granting the marketing authorisation for the following variations: This deadline is legally binding and must be adhered to. The explanatory note will form the basis of the upcoming revision of GPV VII; this update, once finalised, will therefore supersede this guidance document.