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. This will allow the Agency and the national competent authorities to update the dossier of each marketing authorisation included in the worksharing procedure with the relevant amended or new information. Grouped variations can be subject to a worksharing procedure, provided that the same group of variations applies to all medicinal products concerned by the worksharing procedure. From 1 March , the use of the eSubmission Gateway or web client is mandatory for all electronic Common Technical Document eCTD submissions through the centralised procedure. This page lists questions that marketing-authorisation holders MAHs may have on worksharing. Such opinions will also list any variations e.
A single decision will be issued for each centrally authorised medicinal product. See grouping of variations: One original cover letter addressed to the Agency and national competent authorities, if nationally authorised medicinal products are part of the worksharing procedure, clearly indicating that the application is submitted for a worksharing procedure together with a short overview of all medicinal products concerned, with their respective rapporteurs , RMSs and national competent authorities, as applicable, as well as an overview of the submission format for the different products, if applicable e. The cover letter should include the e-mail address of the person in charge. If amendments are requested by the Agency as a result of the validation, updated documentation should also be submitted to the MSs. Marketing Authorisation Holders are advised to submit such variations as usual.
Annex B includes information on the nationally authorised medicinal products included in the worksharing application if applicable. Where applicable, revised product information Annexes including Annex A, if applicable should be included in electronic Word and PDF format in the same eSubmission Gateway or eSubmission Web Client package within a folder called ‘working documents’.
Heads of Medicines Agencies: Variations
In principle, identical modules will have to be provided for each product included in the worksharing. References The linguistic review process of product information in the centralised procedure — Human. Covsr regulatory Overview Research and development Marketing authorisation Post-authorisation Herbal products.
In order to facilitate the planning of a worksharing procedure, MAHs are advised to inform the Agency at least two months in advance of the submission of a variation or group of variations to be subject to a worksharing procedure, together with an explanation as to why the holder believes that a worksharing procedure is suitable, by means of a ‘letter of intent’.
A single decision will be issued for each centrally authorised medicinal product. How useful was this page? Only one centrally authorised medicinal product will undergo a linguistic check.
In order to avoid duplication of work in the evaluation of such variationsa worksharing procedure has been established under which one authority the ‘reference authority’chosen amongst the competent authorities of the Member States and the Agency, will examine the variation on behalf of the other concerned authorities.
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.
Where nationally authorised medicinal products are part of the worksharingthe same application as submitted to the Agency should be submitted to all Member States, even if some products are not relevant to some MSs. For queries relating to the presentation of the application, please contact the Agency. View all 15 ratings.
Extensions are excluded from worksharing. Type-II variations listed in Article 23 1a a may only be implemented once the Commission has amended the marketing authorisation and has notified the MAH accordingly.
Revision of test method for the active substance. If nationally authorised medical products are part of the worksharing procedure, relevant product and Member State details should be provided as annex B to the application form using the template for annex B. Clean PDF versions should have all changes ‘accepted’. 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.
Two Commission guidelines have been issued in connection with the a. Skip to main content.
Icelandic and Norwegian language versions must always be included. The same general principles as for grouped variations applies. The Agency will allocate a ‘high-level’ cross-products procedure number, which will be used for the handling of worksharing procedures affecting more than lettwr medicinal product.
BfArM – Variations – Submission of Variations
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.
From 1 Marchthe use of the eSubmission Gateway or web client is mandatory for all electronic Common Technical Document eCTD submissions through the centralised procedure.
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 as one integrated submission package electronic-common-technical-document [eCTD] sequence per product, covering all variations applied for. This Page Recommend page. Navigation and service Go to: 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.
Decision-making process for centrally authorised medicinal products. For variations that affect annex A e.
Applications for Marketing Authorisation
Update eltter the Certificate of European Pharmacopeia. This applies to all applications for human medicines. Therefore, where the ‘same’ changes to different marketing authorisations require the submission of individual supportive data sets for each medicinal product concerned, which each require a separate product-specific assessment, such changes will not benefit from worksharing.