The MAH is expected to provide, as applicable, by Day We recommend that you use a validation tool to check your submission. Once MHRA has all the documents, it will take days, reduced timetable , days 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. Such opinions will also list any variations e. 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:

Any changes not listed will not be considered as part of the variation application. Skip to main content. Type IA changes have little or no impact on the quality, safety or efficacy of the product, for example administrative modifications such as:. Clean PDF versions should have all changes ‘accepted’. Good quality of the translations and compliance with the Member States’ comments is required to facilitate the process. However, in exceptional cases where MAHs take the opportunity to introduce minor linguistic amendments in the texts e. 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.

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. Upon adoption of the CHMP opinion on the worksharing procedure, the Agency will inform the MAH and Member Letter concerned if applicable as to whether the opinion is favourable or unfavourable including the grounds for the unfavourable outcomeas well as whether the Commission decision granting the Union marketing authorisations requires any amendments.

cmdh variation cover letter template

MAHs should contact the relevant Risk Templte Specialist in case of such requests if there is a need for initial clarification on the process. This will include a cover letter and electronic application form, together with separate supportive documentation for each medicinal product concerned and revised product information if applicable for each medicinal product concerned.

For these active substancesthe frequency of submission is established at national level. Applicants are leter advised to use the pre-submission checklist below which will reduce the likelihood of the submitted application being invalidated or rejected.


This will allow the Agency and the national competent authorities to update the dossier of each marketing authorisation included in the worksharing procedure with the relevant amended or new information. CMDh best practic guide Purely nationally authorised medicinal products are considered those which contain substances or a combination of actives substances which are only authorised in one Member State.

Highlighted changes should be indicated via ‘Tools — Track changes’. One original cover letter addressed to the Agency and national competent authorities, if nationally authorised medicinal products are part of the worksharing procedure, clearly indicating that the application is submitted for a worksharing procedure together with a short overview of all medicinal products concerned, with their respective rapporteurs tem;late, RMSs and national competent authorities, as applicable, as well as an overview of the submission format for the different products, if applicable e.

Where relevant, data relating to a particular indicationdosage form, and route of administration or dosing regimen, shall be presented in a separate section of the PSUR and any safety concerns shall be addressed accordingly.

The EMA has published further guidance on how the fees are calculated and collected.

Variation Procedure

Thank you for your feedback. A revised timetable will then be prepared. 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.

Unless otherwise requested by competent authorities, the marketing authorisation holder shall prepare a single PSUR for all its medicinal products containing the same active substance with information covering all the authorised indicationsroute of administrationdosage forms and dosing regiments, irrespective of whether authorised under different names and through xover procedures. Whilst changes become binding 6 months after publication, there cocer exceptionally be situations where PSUR submissions are necessary prior to the new frequency taking effect and this will be indicated in the EURD list as well.

You should type the full details of your query in the appropriate space. To further facilitate the check and assessment, the MAH should present clean and tracked changes Word versions of the RMP in the submission. Extensions are excluded from worksharing.


Amendments to the SmPC, labelling and package leaflet as a result of the PSUR assessment are implemented without subsequent variation submission for centrally authorised products and through the appropriate variation at national level for nationally authorised products including those authorised through the mutual recognition and decentralised procedures.

For nationally authorised productsinterim results, if requested, need to be submitted to the relevant competent authority unless specified otherwise. The European Union reference date EURD corresponds to the date of the first or the earliest known date of the marketing authorisation in the EU of a medicinal product containing the active substance or combination of active substances. If the contact details you provide are incomplete or inaccurate this may prevent the Agency from communicating vaeiation you.

From 1 Marchthe use of the eSubmission Gateway or web client is mandatory for all electronic Common Technical Document eCTD submissions through the centralised procedure.

Heads of Medicines Agencies: Variations

References Fees payable to the European Medicines Agency. Type-II variations approved via a worksharing procedure, which do not require any amendment of the 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 case of CMDh position by cmdu, Member States may perform a voluntary linguistic review in the translation process, therefore the following timelines varlation This can result in having to submit a large number of sets of tracked change product information with the additional burden of providing translations.

A new procedure code abbreviation is used for worksharing procedures i. Additional tejplate will be regularly included to reflect accumulated experience. The MAH is expected to provide, as applicable, by Day Requests for a reduced timescale should be made to variationqueries mhra.

cmdh variation cover letter template

For more information on how to use the PSUR repository, see: This will, where appropriate, allow one single assessment of PSURs for products containing the same active substance.

You can see details of this in the annex of the EU dover.