CMDH COVER LETTER TEMPLATE VARIATION

Submission to the National Competent Authorities Where nationally authorised medicinal products are part of the worksharing , the same application as submitted to the Agency should be submitted to all Member States, even if some products are not relevant to some MSs. 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. A PDF version of the entire post-authorisation guidance is available: Further current information is available on the CMD h Web page:. The two guidelines are available on the Web page of the European Commission. 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.

The details of the applicant where the invoice should be sent to should be clearly stated in the cover letter. Article 23 1a a provides for a two-month timeframe for amending the decision granting the marketing authorisation for the following variations: The letter should be sent to pa-bus ema. 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’. Human regulatory Overview Research and development Marketing authorisation Post-authorisation Herbal products.

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Only one centrally authorised medicinal product will undergo a linguistic check. 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.

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See grouping of variations: Submission to the National Competent Authorities Where nationally authorised medicinal products are part of the worksharingthe same application as submitted to the Agency should be submitted to all Member States, even if some products are templtae relevant to some MSs.

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 templat a comprehensive set of services covering all aspects of the electronic drug regulatory affairs business. MAHs must in all cases comply with the requirements of Community legislation. 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.

Two Commission guidelines have been issued cmxh connection with the a. The MAH must submit the variation application vriation worksharing at the latest by the recommended submission dates published under submission dates.

Heads of Medicines Agencies: Applications for MA

The cover letter should include the e-mail address of the person in charge. Worksharing procedure for type-II variations. Applicants belonging to the same mother company or group of companies and fover having concluded agreements or exercising concerted practices concerning the placing on the market of the medicinal products concerned, have to be taken as ‘the same MAH’ 1.

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cmdh cover letter template variation

For all worksharing procedures, including those which contain nationally authorised medicinal productsthe ‘high-level’ procedure number should be systematically obtained from the Agency shortly before submission by sending your request with a letter of intent to: If amendments are requested by the Agency as a result of the validation, updated documentation should also be lwtter to the MSs.

Revised topics are marked ‘New’ or ‘Rev. If nationally authorised medicinal products are part of the worksharing procedure, the MAH should also include a confirmation that the lstter applications have been submitted to cmvh Member States where the products concerned are authorised and that the relevant national fees have been paid.

Worksharing procedures have to be applied for at the CMD h. For queries relating to the presentation of the application, please contact the Agency. All the other variations will follow a yearly timeframe for update of the respective Commission decision. The two guidelines are available on the Web page of the European Commission. 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.

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

Heads of Medicines Agencies: Variations

If considered necessary, an oral explanation can be held within this day timeframe. Any changes not listed will not be considered as part of the variation application. Where applicable changes in Word documents should be indicated using ‘Tools-Track Changes’. 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:. In principle, identical modules will have to be provided for each product included in the worksharing.

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Therefore, where the ‘same’ changes to different marketing authorisations require the submission of individual supportive data sets for each medicinal product concerned, which each require a separate product-specific assessment, such changes will not benefit from worksharing.

cmdh cover letter template variation

The agreed changes should be included in the annexes of any subsequent regulatory procedures. The amended German texts are not needed before the national phase is started. Questions and answers relating to practical and technical aspects of the implementation and the eSubmission Gateway web client: 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.

Highlighted changes should be indicated via ‘Tools — Track changes’. For variations that affect annex A e. 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.

Quality Changes to the active-substance master file.