CMDH COVER LETTER TEMPLATE VARIATION

In case of comments, it will be up to the MAH to correctly implement the same amendments in the other centrally authorised products , as appropriate. References Fees payable to the European Medicines Agency. The annexes provided should only reflect the changes introduced by the variation concerned. This Page Recommend page. Quality Changes to the active-substance master file. Where a worksharing application is considered invalid i.

Where a worksharing application is considered invalid i. If the variations subject to worksharing affects the summary of product characteristics SmPC , labelling or package leaflet , the revised product information annexes must be submitted as follows: Article 23 1a a provides for a two-month timeframe for amending the decision granting the marketing authorisation for the following variations:. The day period may be reduced having regard to the urgency of the matter, particularly for safety issues, or may be extended to 90 days for Type II variations concerning changes or additions to the therapeutic indication. Update of the Certificate of European Pharmacopeia. The grounds for the re-examination request must be forwarded to the Agency within 60 days of receipt of the opinion. This page lists questions that marketing-authorisation holders MAHs may have on worksharing.

In the variation application form, use the full German name of the medicinal product as it is authorised, and indicate the German marketing authorisation holder as well as the Germanmarketing authorisation number. For nationally authorised medicinal products eCTD strongly recommened.

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’.

Upon receipt of the final opinion, the Member States concerned shall approve the final opinion, inform the Agency accordingly and where necessary, amend the national marketing authorisations within 60 days. If considered necessary, an oral explanation can be held within this day timeframe. Revised topics are marked ‘New’ or ‘Rev.

cmdh cover letter template variation

Article 23 1a a provides for a two-month timeframe for amending the decision granting the marketing authorisation for the following variations:. Examples of changes which would be considered suitable for evaluation under worksharing:.

Applications for Marketing Authorisation

Within 60 days from the receipt of the grounds for re-examinationthe CHMP will consider whether its opinion is to be revised. This means that the MAH may give written notice to the Agency coover 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.

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Icelandic and Norwegian language versions must always be included. Our highly experienced team of regulatory affairs, documentation and IT professionals provides a variattion set of services covering all aspects of the electronic drug regulatory affairs business.

Clean versions should have all changes ‘accepted’.

cmdh cover letter template variation

In order to facilitate the planning of a worksharing procedure, MAHs are advised to inform the Agency at least two months in advance of clver 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’. Type-IB variations approved via a worksharing procedure may be implemented upon receipt of the favourable CHMP opinion.

Our services include submission hosting, processing of individual submission documents as well as consultancy in all questions of electronic drug regulatory business. If the variations subject to worksharing affects the summary of product characteristics Tfmplatelabelling or package leafletthe revised product information annexes must tempplate submitted as follows:. 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 leter sending your request with a letter of intent to: A single decision will be issued for each centrally authorised medicinal product.

Update of the Certificate of European Pharmacopeia. In general, variations submitted for worksharing will follow the day evaluation timetable of Type II variations and weekly-start timetables may apply to the assessment following the same principles as those applied to the assessment of Type II variations. Grouped variations can be subject to a worksharing procedure, provided that the same group of variations applies to all medicinal products concerned by the worksharing procedure.

The letter should be sent to pa-bus ema. Provisions that extend to Iceland, Liechtenstein and Norway by virtue of the European Economic Area agreement are outlined in the relevant sections of the text.

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An electronic copy containing the relevant eCTD sequence for each product, should be submitted to the Agency. The annexes provided should only reflect the changes introduced by the variation concerned. Type-II variations listed in Article 23 1a a may only be implemented once the Commission has amended the marketing authorisation and has notified the MAH accordingly. Annex B includes information on the nationally authorised medicinal products included in the worksharing application if applicable.

Upon receipt of a favourable CHMP opinion that temlate amendments to the decision granting the marketing vmdhthe Commission shall amend the marketing variatiob 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 letteer. Worksharing procedure for multiple centrally authorised medicinal products ‘duplicates’ The submission of a formal variatiob of intent is not required, however applicants are advised to request a WS number from PA-BUS ema.

Heads of Medicines Agencies: Applications for MA

European Mcdh Agency templzte 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. Where at least one of the concerned marketing authorisations has been authorised via the centralised procedurethe Agency will be the ‘reference authority’.

For such procedures, a linguistic review will take place in parallel to the scientific assessment. It is expected that the co- rapporteur will be one of the rapporteurs of the centrally authorised medicinal products or a CHMP member representing one of the RMSs or national competent authorities for the nationally authorised products.

If nationally authorised medical products are part of the worksharing procedure, relevant product templaet Member State details should be provided as annex B to the application form using the template for annex B.