COVER LETTER CMDH VARIATION

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. 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: Where at least one of the concerned marketing authorisations has been authorised via the centralised procedure , the Agency will be the ‘reference authority’. A letter of intent template is available. Extensions are excluded from worksharing.

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. 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. 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. 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. 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 form contains information on where to send article source cover cmdh which information regarding the sample that should be provided. Revision of test method for the active substance.

Refer to the variarion variations question-and-answer document for guidance on the submission of variations in eCTD format. Revised topics are marked ‘New’ or ‘Rev. The MAH will be informed accordingly.

cover letter cmdh variation

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’. If considered necessary, an oral explanation can be held within this day timeframe.

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If amendments are requested by the Agency as a result of the validation, updated documentation should also be submitted to the MSs. This letter will become part of coevr MA package and must be retained with the formal documents relating to the licence.

Worksharing: questions and answers

All EU languages including Norwegian and Icelandic: Where at least one of the concerned marketing authorisations has been authorised via the centralised procedurethe Agency will be the ‘reference authority’. Lettwr, 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.

cover letter cmdh variation

In principle, identical modules will have to be provided for each product included in the worksharing. Batch specific requests To ensure continued availability [URL] a medicinal cover on the market in Malta, batch cover requests can be submitted.

If the MAH requests covet the Committee consult a scientific advisory group in connection with the re-examinationthe applicant should inform the CHMP as soon as possible. It provides an overview of the European Medicines Agency’s position on issues that are typically addressed in discussions or meetings with MAHs in the post-authorisation phase.

Heads of Medicines Agencies: Variation

However, in exceptional cases where MAHs take the opportunity to introduce minor linguistic amendments in the texts e. 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 not relevant to some MSs.

cover letter cmdh 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:. The Agency applies the existing post-opinion timeframes, as set-out in the linguistic review process of product information in the centralised procedure — human. Type-II variations approved via a worksharing procedure, which do not require any amendment of cmh 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 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. This will allow all the involved Parties The Agency, MSs and Committee Members to receive the full data for the worksharing application. Update of the Certificate of European Pharmacopeia.

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Where the outcome of the procedure is favourable and the Commission decision granting the marketing authorisation requires amendments, the Agency will inform the Commission accordingly. Schematic structure of the CHMP opinion and annexes for an application under worksharingconsisting of centrally and nationally authorised medicinal products: However, in exceptional cases non-critical deviations may be considered on a case-by-case variation.

For nationally authorised medicinal products eCTD strongly recommened. The grounds for the re-examination request must be forwarded to the Agency within 60 days vagiation receipt of the opinion.

The Mcdh 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.

Variation Procedure

If justified, an empty sample of the letter can be sufficient, for variation if the filled package is very large. Worksharing procedures lwtter type-IB variations At submission day 0: References The linguistic review process of product information in the centralised procedure — Human. Complete set of annexes of one CAP electronically only c,dh Word format highlighted. 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.

For all worksharing procedures, including those which contain nationally authorised medicinal productsthe ‘high-level’ procedure number should be systematically obtained from cdmh Agency shortly before submission by sending your request with a letter of intent to: 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.