Worksharing procedures for type-IB variations. Decision-making process for centrally authorised medicinal products. It provides an overview of the European Medicines Agency’s position on issues that are typically addressed in discussions or meetings with MAHs in the post-authorisation phase. Questions and answers relating to practical and technical aspects of the implementation and the eSubmission Gateway web client: Welcome to Exalon Your partner for high quality eCTDs, regulatory submission services and EVMPD support Our highly experienced team of regulatory affairs, documentation and IT professionals provides a comprehensive set of services covering all aspects of the electronic drug regulatory affairs business. Applicants must not send any accompanying hard media or separate paper cover letter as the cover letter will be in the relevant part of eCTD module 1 in PDF format. Type-IB variations approved via a worksharing procedure may be implemented upon receipt of the favourable CHMP opinion.
Where a worksharing application is considered invalid i. For nationally authorised medicinal products eCTD strongly recommened. Annex A for each centrally authorised medicinal product included in the worksharing procedure will be annexed to the CHMP opinion. Based on Articles 7 and 20 of the Variations Regulation, when a group of variations only consists of type-IA or -IA IN variations affecting several marketing authorisations , this is considered as a ‘group’ of variations and not a ‘ worksharing ‘ procedure. The agreed changes should be included in the annexes of any subsequent regulatory procedures. Examples of changes which would be considered suitable for evaluation under worksharing:
Complete set of annexes of one CAP electronically only in Cariation format highlighted. A new procedure code abbreviation is used for worksharing procedures i. Examples of changes which would be considered suitable for evaluation under worksharing:. Worksharing procedure for type-II variations At submission day 0: While the first guideline provides detailed operational advice as well as information on the documentation variaiton be submitted, the second covsr details of the variation categories i.
A formal letter with the worksharing applicant and contact person for the worksharing procedure should be provided with the worksharing application. If amendments are requested by the Agency as a result of the validation, updated documentation should also be submitted to the MSs.
The two guidelines are available on the Web page of the European Commission. Decision-making process for centrally authorised medicinal products.
Additional examples will be regularly included to reflect accumulated experience. References The linguistic review process of product information in the centralised procedure — Human. In all other cases, etmplate national competent authority chosen by the Coordination Group, taking into account the recommendation of the holder, will act as the ‘reference authority’.
Heads of Medicines Agencies: Applications for MA
However, in exceptional cases where MAHs take the opportunity to introduce minor linguistic amendments in the texts e. The Agency applies the existing post-opinion timeframes, as set-out in the linguistic review process of product information in the centralised procedure — human. The same general principles as for grouped variations applies. An electronic copy containing the relevant eCTD sequence coer each product, should be submitted to the Agency. Worksharing procedures for type-IB variations.
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In the cases where the changes to the product information may vary between products, the product with the lettet complex changes will generally be the one subject to linguistic check. Upon adoption of the CHMP opinion on the worksharing procedure, the Agency will inform the MAH and Member States concerned if applicable as to whether the opinion is favourable or unfavourable including the grounds for the unfavourable outcomeas well as whether the Commission decision granting the Union marketing authorisations requires any amendments.
If the variations subject to worksharing affects the summary of product characteristics SmPClabelling or package leafletthe revised product information annexes must be cariation as follows: A letter of intent template is available. Upon receipt of the final opinion, the Member States concerned shall approve the final opinion, tenplate the Agency accordingly and where necessary, amend the national marketing authorisations within 60 days.
Welcome to Exalon Your partner for high quality eCTDs, regulatory submission services and EVMPD support Our highly experienced vagiation of regulatory affairs, documentation and IT professionals provides a comprehensive set of services covering all aspects of the electronic drug regulatory affairs business.
The dossier requirements for post-authorisation submissions in the centralised procedure should be followed. In general, variations submitted for worksharing will follow the day evaluation timetable of Type II variations and weekly-start timetables may apply to the coger following the same principles as those applied to the assessment of Type II variations.
Variations related to safety issues, including urgent twmplate restrictionsmust be implemented within a timeframe agreed by the marketing authorisation holder and the Agency. Page numbering should start with ‘1’ bottom, centre on the title page of annex I.
The submission requirements as set out in the post-authorisation-guidance sections for the different types of variations will also apply to variations subject to worksharingbut the application should be provided fmdh one integrated submission package electronic-common-technical-document [eCTD] sequence per product, covering all variations applied for.
A single decision will be issued for each centrally authorised medicinal product. This Page Recommend page. Our highly experienced team of regulatory affairs, documentation and IT professionals provides a comprehensive set of services covering all aspects of the electronic drug regulatory affairs business.
Any changes not listed will not be considered as part of the variation application. For such procedures, a linguistic review will take place in parallel to the scientific assessment. Submission to the National Competent Authorities Where nationally authorised medicinal products are part of the worksharingthe same application as submitted coved the Agency should be submitted to all Member States, even if some products dover not relevant to some MSs.
The response from the Agency on the acceptability of the worksharing application, further to the submission of the letter of intent should be attached to the application form. The MAH will be informed accordingly. Also see ‘when do I have to submit revised product information?