COVER LETTER VARIATION CMDH

Examples of changes which would be considered suitable for evaluation under worksharing: An electronic copy containing the relevant eCTD sequence for each product, should be submitted to the Agency. 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. Worksharing procedure for multiple centrally authorised medicinal products ‘duplicates’. The complete set of annexes must be presented sequentially i. A new procedure code abbreviation is used for worksharing procedures i.

The dossier requirements for post-authorisation submissions in the centralised procedure should be followed. A single decision will be issued for each centrally authorised medicinal product. 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 products concerned are authorised and that the relevant national fees have been paid. 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. In the cases where the changes to the product information may vary between products, the product with the most complex changes will generally be the one subject to linguistic check. In such cases, and in cases where any other ongoing procedures may affect the product information annexes, the MAH is advised to contact the Agency in advance of submission or finalisation of the procedure concerned. 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.

Paper submissions are not accepted. The MAH will be informed accordingly.

Variation Procedure

Submission to the Rapporteur and Committee members. 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 lettfr.

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Navigation and service Go to: 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.

cover letter variation cmdh

Further current information is available on the CMD h Web page:. 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. In principle, identical modules will have to be provided for each product included in the worksharing.

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’. For information on the fees applicable for worksharing applications, please refer to fees payable to the European Medicines Agency. Any changes not listed will not be considered as part of the variation application.

For queries relating to the presentation of the application, please contact the Agency. 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.

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 shorter presubmission phase is envisaged in cases where: Type-IB variations approved via a worksharing procedure may be implemented upon receipt of the favourable CHMP opinion.

Heads of Medicines Agencies: Variation

The following remarks may be helpful: Expand section Collapse section. The worksharing application must be submitted at the same time to all relevant authorities, i. In order to benefit from a worksharing procedure, it is required that the same changes will apply to the different medicinal products concerned, with either no or limited need for assessment of a potential product-specific impact.

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Clean versions should have all changes ‘accepted’. Worksharing procedure for multiple centrally authorised medicinal products ‘duplicates’. The letter of intent should provide the following information: The complete set of annexes must be presented sequentially i. In the cases where the changes to the product information may vary between products, the product with the most complex changes will generally be the one subject to linguistic check.

cover letter variation cmdh

variatiin Where applicable changes in Word documents should be indicated using ‘Tools-Track Changes’. Decision-making process for centrally authorised medicinal products Upon receipt of a favourable CHMP opinion that requires amendments to the decision granting the marketing authorisationthe Commission shall amend the marketing authorisation for each centrally authorised medicinal product to reflect the approved variations within two letger, for the variations listed under Article 23 1a a or within one year for the other variations.

cover letter variation cmdh

If considered necessary, an oral explanation can be held within this day timeframe. All EU languages including Norwegian and Icelandic: The annexes provided should only reflect the changes introduced by the variation concerned.

Clean PDF versions should have mcdh changes ‘accepted’. Worksharing procedures have to be applied for at the CMD h. Supporting documentation for each product including the revised summary of product characteristicslabelling and package leafletif applicable. How useful was this page? See grouping of variations: