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Revised topics are marked ‘New’ or ‘Rev. References Fees payable to the European Medicines Agency. An automated acknowledgement email is sent from the system confirming whether the submission has passed the relevant technical validation criteria and whether it has been uploaded to the Agency’s review tool and made available via the Common Repository. If the MAH requests that the Committee consult a scientific advisory group in connection with the re-examination , the applicant should inform the CHMP as soon as possible. This will allow all the involved Parties The Agency, MSs and Committee Members to receive the full data for the worksharing application. MAHs must in all cases comply with the requirements of Community legislation. The worksharing application must be submitted at the same time to all relevant authorities, i.

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. Provisions that extend to Iceland, Liechtenstein and Norway by virtue of the European Economic Area agreement are outlined in the relevant sections of the text. 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. An electronic copy containing the relevant eCTD sequence for each product, should be submitted to the Agency. Introduction or changes to the pharmacovigilance system.

Revision of test method for the active substance. If the variations subject to worksharing affects the summary of product characteristics SmPClabelling or package leafletthe revised product information annexes must be submitted as follows: Human regulatory Overview Research and development Marketing authorisation Post-authorisation Herbal products.

Heads of Medicines Agencies: Applications for MA

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. Supporting documentation for each product including the revised summary of product characteristicslabelling and package leafletif applicable.


Alternatively, such a listing may be provided as a separate document attached to the application form. 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. A single decision will be issued for each centrally authorised medicinal product.

Variation Procedure

Variations related to safety issues, including urgent safety restrictionsmust be implemented within a timeframe agreed by the marketing authorisation holder and the Agency. Retweet on Twitter exalon Retweeted.

cmdh cover letter template variation

Extensions are excluded from worksharing. Also see ‘when do I have to submit revised product information? Where a worksharing application is considered invalid i. Our services include submission hosting, processing of individual submission documents as well as consultancy in all questions of lettr drug regulatory business. Upon receipt of a favourable CHMP opinion that requires amendments to the decision granting variztion marketing authorisationthe Commission shall amend the marketing authorisation for each centrally authorised medicinal product to reflect the approved variations within two months, for the variations listed under Article 23 1a a or within one year for the other variations.

Applications for Marketing Authorisation

Schematic structure of the CHMP opinion and annexes for an application under worksharingconsisting of centrally and nationally authorised medicinal products: When submitting the full set of annexes in PDF format, this should be accompanied by the completed formatting checklist and following the user guide on how to generate PDF versions of the product information – human. Icelandic and Norwegian language versions must always be included. Update of the Certificate of European Pharmacopeia.

Further current information is available on the CMD h Web page: Worksharing procedures for type-IB variations. Paper submissions are not 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.

If Type IA or IB variations include alterations of the German texts, submit highlighted and clean versions along with the initial application; this applies to electronic submissions as well see the AMG -Submission Ordinance. 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 outcometempalte well as whether the Commission decision granting the Union marketing authorisations requires any amendments.


Where at least one of the concerned marketing authorisations has been authorised via the centralised procedurethe Agency will be the ‘reference authority’.

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 rapporteursRMSs and national competent authorities, as applicable, as well as an overview of the submission format for the different templwte, if applicable e.

These questions and answers have been produced variatiom guidance only and should be read in conjunction with the rules governing medicinal products in the European Union, volume 2, notice to applicants.

Exalon – eCTD-Experts

For variations that affect annex A e. Lrtter to the eCTD variations question-and-answer document for guidance on the submission of variations in eCTD format.

cmdh cover letter template variation

Marketing-authorisation-updating process for nationally authorised medicinal products if applicable. A letter of intent template is available. Navigation and service Go to: Veterinary regulatory Overview Research and development Marketing authorisation Post-authorisation. For information on the fees applicable for worksharing applications, please refer to fees payable to the European Medicines Agency. The letter of intent should provide the following information: One completed electronic EU variation application form, listing all medicinal products concerned and declaring all 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.