Marketing-authorisation-updating process for nationally authorised medicinal products if applicable. Worksharing procedure for type-II variations At submission day 0: Subsequently, the Agency will initiate the Rapporteur appointment procedure. Such opinions will also list any variations e. Changes to a single-substance MA and a fixed-combination MA containing the same active substance.

Decision-making process for centrally authorised medicinal products. Also see ‘when do I have to submit revised product information? 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. The worksharing application must be submitted at the same time to all relevant authorities, i. 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.

Any changes not listed will not be considered as part of the variation application. 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: Complete set of Annexes for all centrally authorised products CAPs electronically only in Word format highlighted.

A single decision will be issued for each centrally authorised medicinal product.

cmdh cover letter template variation

See grouping of variations: Worksharing procedure for type-II variations. We are publishing eCTD submissions for of all types of applications 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. 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 products, if applicable e.


Heads of Medicines Agencies: Applications for MA

Subsequently, the Agency will initiate the Rapporteur appointment procedure. Extensions lefter excluded from worksharing. Questions and answers relating to practical and technical aspects of the implementation and the eSubmission Gateway web client: Additional examples will be regularly included to reflect accumulated experience.

Alternatively, such a listing may be provided as a separate document attached to the application form.

Navigation and service

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. The dossier requirements for post-authorisation submissions in the centralised procedure should be followed.

View all 15 ratings. The same general principles as for grouped variations applies. Decision-making process for centrally authorised medicinal products.

An electronic copy containing the relevant eCTD sequence for each product, should be submitted to the Agency. 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.

In addition to our electronic publishing services we support the registration of your medicinal products in xEVMPD in acc. 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.

cmdh cover letter template variation

For information on the fees applicable for worksharing applications, please refer to fees payable to the European Medicines Agency. 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. For such procedures, a linguistic review will take place in parallel to the scientific assessment. The amended German texts are not needed before the national phase is started.


This means that the MAH may give written notice to the Agency or CHMP that it wishes to request a re-examination within 15 days of receipt of the opinion after which, if it does not appeal, the opinion will be considered final.

cmdh cover letter template variation

Paper submissions are not accepted. All EU languages including Norwegian and Icelandic: Worksharing procedures for type-IB variations. Schematic structure of the CHMP opinion and annexes for an application under worksharingconsisting of centrally and nationally authorised c,dh products: Type-IB variations approved via a worksharing procedure may be implemented upon receipt of the favourable CHMP opinion.

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. Type-II variations approved via a worksharing procedure, which do not require any amendment of the marketing authorisation or which follow a yearly update of the respective Commission decision can be implemented 30 days after receipt of the favourable CHMP opinion.