Clean versions should have all changes ‘accepted’. In cases where the wording has to be adapted, a type IB under category C. See the best practice guide on worksharing for details on how to submit an application this way. Purely national marketing authorisations can be included in worksharing procedures submitted as of 4 August The timelines for assessment are for up to days followed by 67 days of Commission decision making process if applicable. A letter of intent template is available.

It should be either a:. For all worksharing procedures, including those which contain nationally authorised medicinal products , the ‘high-level’ procedure number should be systematically obtained from the Agency shortly before submission by sending your request with a letter of intent to: European Medicines Agency post-authorisation procedural advice for users of the centralised procedure 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. Apply for changes to your marketing authorisation, including minor variations type IA and IB, major variations type II and extensions. It should be noted that the PSUSA cut-off date continues to apply to procedures containing nationally authorised medicinal products , and indicates the next upcoming start date for relevant submission deadlines in the EURD list. This is a legally binding requirement from the EU pharmaceutical legislation.

The agreed changes should be included in the annexes of any subsequent regulatory procedures. Whilst changes become binding 6 months after publication, there might exceptionally be situations where PSUR submissions are necessary prior to the new frequency taking effect and this will be indicated in the EURD list as well. Following an expression of interest and based on a rota system, the Chair of the Committee for Medicinal Products for Human Use CHMP will appoint a rapporteur and co-rapporteur when the application includes a new indication for the procedure.

Grouping applications for national MAs For groupings where MAs were granted through a national procedure only, you will need to apply for grouped changes through that respective member state.


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.

cmdh variation cover letter template

Where the procedure includes only NAPs, the procedure ends with the CMDh position in case of consensus and in case of a majority vote, the CMDh position will be followed by a Commission decision CD to the Member States, which respectively have to be implemented according to the timetable indicated in the CMDh position or within 30 days of vsriation CD receipt by the Member States.

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Variation Procedure

A revised timetable will then be prepared. Minor changes are either type 1A or 1B. Maybe Yes this page is useful No this page is not useful Is there letyer wrong with this page? Type-IB variations approved via a worksharing procedure may be implemented upon receipt of the favourable CHMP letter.

The clinical overview submitted in the renewal application should include relevant information to support the benefit-risk re-evaluation of the medicinal product. The MHRA will take up to 30 days to process your application. Skip to main content. No specific template needs to be followed for the responses to the request for supplementary information RSI.

cmdh variation cover letter template

MAHs must in all cases comply with the requirements of Community legislation. Good quality of the translations and compliance with the Member States’ comments is required to facilitate the process. This portal replaces the following mailboxes gatewaysupport ema. The Agency will allocate a ‘high-level’ cross-products procedure number, which will be used for the handling of worksharing procedures affecting more than one medicinal product.

Worksharing: questions and answers | European Medicines Agency

Article 23 1a a provides for a two-month timeframe for amending the decision granting the marketing authorisation for the following variations: For more information on how to use the PSUR repository, see: In the absence of a reply within two days, the EMA will assume that no oral explanation is requested.


Depending on the date of the EC decision on the revocation or withdrawal, or the date of expiry of the marketing authorization in case of non- renewalmarketing authorisation holders may still be required to submit a PSUR:. However PSURs should be submitted cmh specified in the conditions of the marketing authorisation for the combination product if anyor otherwise according to the standard submission cycle i. A single decision will be issued lette each centrally authorised medicinal product.

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.


You will be able to contact the RMS throughout the procedure. Medicines and Healthcare products Regulatory Agency. Veterinary regulatory Overview Research and development Marketing authorisation Post-authorisation. Home Health and social care Medicines, medical devices Marketing authorisations, variations and licensing guidance. Procedures that contain nationally authorised products NAP s.

The European Union reference date EURD corresponds to the date of the first or the earliest known date of the marketing authorisation in the EU of a medicinal product containing the active substance or combination of active substances. After the translation process Once the translations are received from the MAH, the Agency will check if all Member States’ comments have been implemented.

Start of the procedure according to the published timetable. The CHMP will appoint a different co- rapporteur to coordinate the re-examination procedure. Page numbering should start with ‘1’ bottom, centre on the title page of annex I.