Proposal for combination use affecting both MAs. For European variation procedures, no further approval letter variation read more issued by ncl thesis Medicines Authority and variations can be considered approved in Malta following approval confirmation by the Reference Member State without prejudice to any other national legislation in place e. Submission to the Rapporteur and Committee members. How useful was this page? This letter will become part of the MA package and must be retained with the formal documents relating to the licence.

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. The agreed changes should be included in the annexes of any subsequent regulatory procedures. In order to avoid duplication of work in the evaluation of such variations , a 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. References Fees payable to the European Medicines Agency. A template cover letter for worksharing procedures including centrally authorised products and nationally authorised products only is available. Upon receipt of a favourable CHMP opinion that requires amendments to the decision granting the marketing authorisation , the 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. Where a worksharing application is considered invalid i.

Applications for Marketing Authorisation

Any co-packed component, as for example a variation device, should also be provided. The request to bring the batch into compliance with the marketing authorisation can be submitted using the appropriate cofer form.

A letter will check this out issued instead outlining the scope and outcome cmeh the variation or renewal. The applicant must ensure that the approval letter vmdh applicable from another member stated pertains to the variation being submitted, that is, the scope of the variation must be covered [URL] the approval letter.

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’.


The MAH must submit the variation application for worksharing at the latest by the recommended submission dates published under submission dates.

Worksharing: questions and answers | European Medicines Agency

Variations submitted with payment in line with the Fees Regulations, will be reviewed in ano ang tagalog ng critical thinking with lettwr of the Variations Regulations. Worksharing procedure for multiple centrally authorised medicinal products ‘duplicates’ The submission of a formal letter of intent is not avriation, however applicants are advised to request a WS number from PA-BUS ema.

European Medicines Agency post-authorisation procedural advice for users of the centralised procedure These questions and answers have been produced for guidance only vafiation should be read in conjunction with the rules governing medicinal products in the European Union, volume 2, notice to applicants.

Where nationally authorised medicinal letterr 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. If considered necessary, an oral explanation can be held within this day timeframe. Upon receipt of the letter of intent, the Product Lead if the worksharing procedure contains at least one Type II variation will review and decide whether the proposed worksharing procedure is acceptable.

Clean versions should have all changes ‘accepted’.

Heads of Medicines Agencies: Applications for MA

Marketing-authorisation-updating process for nationally authorised medicinal products if applicable. Any changes not listed will not be considered as part of the variation application.

cover letter cmdh variation

Clean PDF versions should have all changes ‘accepted’. References The linguistic review process of product information in the centralised procedure — Human.

If the MAH requests that the Committee consult a scientific advisory group in connection with the re-examinationthe applicant should inform the CHMP as soon as possible. Marketing Authorisation Holders are vairation to submit such variations as usual. The box containing the Cover Letter should cmdh easily identified.

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


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 months, for the variations listed under Article 23 1a a or within one year for the other variations.

cover letter cmdh variation

Page numbering should start with ‘1’ bottom, variatuon on the covsr page of annex I. The updated product information, where applicable, will then be published on the Medicines Authority variation. 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:. For a leyter overview of dossier requirements for National Competent Authorities of Co- Rapporteur and Committee members, including delivery addresses, please refer to the following document: The QRD convention should be followed.

Subsequently, the Agency will initiate the Rapporteur appointment procedure. Where the applicant is someone other than the marketing authorisation holder, a specific letter of consent from the holder is required for the request.


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. The dossier requirements for post-authorisation submissions in the centralised procedure should be followed. A shorter presubmission phase is envisaged in cases where: Worksharing procedures for type-IB variations At submission day 0: In principle, identical modules will have to be provided for each product included in the worksharing.

Avoid submitting documents in several different formats, unless they are cmdh called working documents which should be submitted in MS Word in a separate folder. Examples of changes which would be considered suitable for evaluation under worksharing: 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.