CMDH VARIATION COVER LETTER TEMPLATE

Published 18 December Last updated 9 March — see all updates. Proposals for worksharing applications should be sent to:. 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. Where a worksharing application is considered invalid i. If a type IA variation is included in a group with other types of variations, the type IA change should not be implemented until all changes for that group have been approved.

Questions and answers relating to practical and technical aspects of the implementation and the eSubmission Gateway web client: The clinical overview submitted in the renewal application should include relevant information to support the benefit-risk re-evaluation of the medicinal product. 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. 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: For groupings where MAs were granted through a national procedure only, you will need to apply for grouped changes through that respective member state. If relevant, the summary of product characteristic fragments SPC should be submitted to MHRA in the correct format using the templates below.

Worksharing procedures for type-IB variations At submission day 0: For centrally authorised products interim results not impacting on the product information or on the condition as stated in the Annex II of the marketing authorisation can be submitted as a post-authorisation measure PAM as described in question How and to whom shall I submit my PAM data see Post-authorisation measures: This will allow the Agency and the national competent authorities to update the dossier of each marketing authorisation included in vqriation worksharing procedure with the relevant amended or cmeh information.

Heads of Medicines Agencies: Variations

In general, variations submitted for worksharing will follow the day evaluation timetable of Type II variations and weekly-start timetables may apply variahion the assessment following the same principles as those applied to the assessment of Type II variations.

Article 23 1a a provides for a two-month timeframe for amending the decision granting the marketing authorisation for the following variations:.

It will take only 2 minutes to fill in. Please refer to the guideline on the processing of renewals in the centralised procedure. However as the reference product information might be different for the various EU cmeh informationit is essential that the MAH considers the proposed changes for the reference product information in the context of the different EU product information for the products covered by the submitted PSUR. 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.

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This form is a guide only. In all other cases, a national competent authority chosen by the Coordination Group, taking into account the recommendation of the ttemplate, will act as vaeiation ‘reference authority’. Day days after position The MAH s will implement the required changes. It should be noted that the responsibility for the quality of the submitted documentation lies with the MAH s and is crucial to the overall assessment. Home Health and letfer care Medicines, medical devices Marketing authorisations, variations and licensing guidance.

cmdh variation cover letter template

If you are making a submission using the portal, you will have to submit using the portal forms as well as submitting the eAF. The submission requirements as set out in the post-authorisation-guidance sections for the different types of variations will also apply to variations subject to worksharingbut the application should be provided as one integrated submission package electronic-common-technical-document [eCTD] sequence per product, covering all variations applied for.

It should be either a:.

cmdh variation cover letter template

Where a marketing authorisation is withdrawn, revoked or not renewed, the former marketing authorisation holder is encouraged to continue to collect spontaneous reports of suspected adverse reactions occurring in the EU see GVP Module VI to, for example, facilitate review of delayed onset adverse reactions or of retrospectively notified cases of adverse reactions.

This can result in having to submit a large number of sets of tracked change product information with the additional burden of providing translations.

cmdh variation cover letter template

Questions and answers relating to practical and technical aspects of the implementation and the eSubmission Gateway web client: View all 15 ratings.

However, the parallel importer will not become party to the PSUR procedure and will not receive a copy of the assessment report and outcome documentation as a MAH would.

Worksharing: questions and answers

Type-IB variations approved via a worksharing procedure may be implemented upon receipt of the favourable CHMP opinion. If the date is after the submission deadline specified in the EURD listsubmission is mandatory irrespective of whether the date is before or after the start date of the procedure. For example, you can make a change to the manufacturing site of the finished product, change in batch size and the manufacturing process to 1 product.

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This means that the MAH may give written notice to the Agency or 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.

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.

If you want to apply for changes to one or more product licences licence for each product under a marketing authorisation that would affect the product information you can submit a composite coordination collection CCC. To further facilitate the check and assessment, the MAH should present clean and tracked changes Word versions of the RMP in the submission.

Once MHRA has all the documents, it will take days, reduced timetabledays standard timetable or days extended complex timetable to assess your application depending on how urgent or complex the changes are, excluding time taken to answer questions. Information on the outcome of centrally authorised medicinal products is made available in the European Public Assessment Report EPAR page of the relevant medicine.

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Applications for Marketing Authorisation

One example of a major change is adding a new therapeutic indication to a product or updating the current indication the medical needs the product is used for.

For translations of Annexes QRD templates for each language should be used Make sure that the title pages are adjusted and all brackets i. For these active substancesthe frequency of submission is established at national level. Training on demand videos are available and you can also sign up to our free online weekly live demonstrations.

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