CMDH COVER LETTER TEMPLATE VARIATION

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. Worksharing procedure for multiple centrally authorised medicinal products ‘duplicates’ The submission of a formal letter of intent is not required, however applicants are advised to request a WS number from PA-BUS ema. 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 outcome , as well as whether the Commission decision granting the Union marketing authorisations requires any amendments. Schematic structure of the CHMP opinion and annexes for an application under worksharing , consisting of centrally and nationally authorised medicinal products: 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.

A formal letter with the worksharing applicant and contact person for the worksharing procedure should be provided with the worksharing application. Supporting documentation for each product including the revised summary of product characteristics , labelling and package leaflet , if applicable. A PDF version of the entire post-authorisation guidance is available: Refer to the eCTD variations question-and-answer document for guidance on the submission of variations in eCTD format. Skip to main content. Introduction or changes to the pharmacovigilance system.

In all other cases, a national competent authority chosen by the Coordination Group, taking into account the recommendation of the holder, will act as the ‘reference authority’. In case of comments, it will be up to the MAH to correctly implement the same amendments in the other centrally authorised productsas appropriate.

cmdh cover letter template variation

This page lists questions that marketing-authorisation holders MAHs may have on worksharing. Upon finalisation of the review of the variations subject to the worksharing procedure, the Agency will issue an opinion reflecting the final outcome of the procedure. While the first guideline provides detailed operational advice as well as information on the documentation to be submitted, the cmfh provides details of the variation categories i.

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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. Where a worksharing application is considered invalid i. The CHMP will appoint a different co- rapporteur to coordinate the re-examination procedure.

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References The linguistic review process of product information in the centralised procedure — Human. A single decision will be issued for each centrally authorised medicinal product. Two Commission guidelines have been issued in connection with the a. For variations that affect annex A e. Where at least one of the concerned marketing authorisations has been authorised via the centralised procedurethe Agency will be the ‘reference authority’. The same general principles as for grouped variations applies.

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. The MAH will be informed accordingly.

cmdh cover letter template variation

For information on the fees applicable for worksharing applications, please refer to fees payable to the European Medicines Agency. In the cases where the changes to the product information vraiation vary between products, the product with the most complex changes will generally be the one subject to linguistic check. Marketing Authorisation Holders are advised to submit such variations as usual. 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.

This will allow all the involved Parties The Agency, MSs and Committee Members to receive the full data for the worksharing application. The dossier requirements for post-authorisation submissions in the centralised procedure should be followed. Worksharing procedures have variatio be applied for at the CMD h.

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The letter of intent should provide the following information: Supporting documentation for each product including the revised summary of product characteristicsvqriation and package leafletif applicable. Our services include variatioh hosting, processing of individual submission documents as well as consultancy in all questions of electronic drug regulatory business.

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 letyer concerned are authorised and that the relevant national fees have been paid.

Heads of Medicines Agencies: Applications for MA

Also see ‘when do I have to submit revised product information? However, in exceptional cases where MAHs take the opportunity to introduce minor linguistic amendments in the texts e.

The QRD convention should be followed. Worksharing procedure for multiple centrally authorised medicinal products ‘duplicates’ The covef of a formal letter of intent is not required, however applicants are advised to request a WS number from PA-BUS ema.

Variations

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.

Veterinary regulatory Overview Research and development Marketing authorisation Post-authorisation. A formal letter with the worksharing applicant and contact person for the worksharing procedure should be provided with the worksharing application.

Worksharing procedures for type-IB variations At submission day 0: For nationally authorised medicinal products eCTD strongly recommened.