Refer to the eCTD variations question-and-answer document for guidance on the submission of variations in eCTD format. For CMDh position by consensus: 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: However, in exceptional cases where MAHs take the opportunity to introduce minor linguistic amendments in the texts e. The clinical overview submitted in the renewal application should include relevant information to support the benefit-risk re-evaluation of the medicinal product.
European Medicines Agency post-authorisation procedural advice for users of the centralised procedure These questions and answers have been produced for guidance only and should be read in conjunction with the rules governing medicinal products in the European Union, volume 2, notice to applicants. Examples of changes which would be considered suitable for evaluation under worksharing:. Where a marketing authorisation is withdrawn, revoked or not renewed, the former marketing authorisation holder is encouraged to continue to collect spontaneous reports of suspected adverse reactions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. PSURs and any related submissions using the existing file naming conventions are no longer possible. Only the worksharing applicant will be invoiced for the worksharing procedure.
For translations of Annexes QRD templates for each language should be used Make sure that the title pages are adjusted and all brackets i. This affects all PSURs irrespective whether they are for centrally or nationally authorised medicinal products and whether they templwte the EU single assessment or purely national PSUR procedure. Grouping applications for national MAs For groupings where MAs were granted through a national procedure only, you will need to apply for grouped changes through that respective member state.
Periodic safety update reports (PSURs)
The Quality Review of Documents QRD linguistic check will be performed on one set of annexes of one centrally authorised medicinal product. Please refer to the guideline on the processing of renewals in the centralised procedure. The EURD 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.
Apply for changes to your marketing authorisation, including minor variations type IA and IB, major variations type II and extensions. When submitting the full set of annexes in PDF format, this should be accompanied by the completed formatting checklist and following the vmdh guide on how to generate PDF versions lehter the product information – human. Covwr more information on GVP modules, see Good pharmacovigilance practices.
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Applications for Marketing Authorisation
References The linguistic review process of product information in the centralised procedure — Human. Within cmsh days from the receipt of the grounds for re-examinationthe CHMP will consider whether its opinion is to be revised. Day days after position The MAH s will implement the required changes. 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.
Leave this field blank. The official contact person for the PSUR procedure is the one provided in the xml delivery file. One completed electronic EU variation application form, listing all medicinal products coger and declaring varriation variations included in the group in the section ‘type of changes’, as well as a justification for the proposed worksharing and grouping if applicable in the ‘precise scope and background’ section of the application form.
Once MHRA has all the documents, it will take days, reduced timetabledays standard timetable or days extended complex timetable to assess your application depending on how urgent or complex the changes are, excluding time taken to answer questions. Only one centrally authorised medicinal product will undergo a linguistic check. 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.
Where the outcome of the procedure is favourable and the Commission decision granting the marketing authorisation requires amendments, the Agency will inform the Commission accordingly. 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 Annexes will be published on the EMA website.
You could be given a further 30 days to respond variatoon any requests for information letter, which for Type IB are referred to as Notification with Grounds letters NWG. Procedures that contain nationally authorised products NAP s.
Heads of Medicines Agencies: Variation
The information and data contained in the individual submissions will be assessed and reflected in the single assessment report. In case the PRAC recommends any regulatory action i.
If the contact details you provide are incomplete or inaccurate this may prevent the Agency from communicating with you. Proposal for combination use affecting both MAs.
Heads of Medicines Agencies: Applications for MA
View all ratings. All EU languages including Norwegian and Icelandic: Since January it has become mandatory for new marketing authorisation, renewal and variation application submissions to be made using electronic application forms eAFs. Send a dispatch date list detailing when you intend to dispatch the products to all member states before submitting your application if your MA was granted through the mutual recognition or decentralised procedures.
For more information, see the questions-and-answers below and Periodic safety update report single assessments.
Worksharing procedures for type-IB variations. The form for this process has a section on extensions.