CMDH VARIATION COVER LETTER TEMPLATE

CMDH VARIATION COVER LETTER TEMPLATE

CMDh Guidance on the Informal Work-Sharing procedure for follow-up for PSUSA for NAPs 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. Once registered you will receive credentials to access the portal to your registered email address. Composite coordination collection CCC – national pilot scheme 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. It addresses specific challenges in the EU single assessment procedure for nationally authorised products , but the issues may also apply to centrally authorised products: The PSUR frequency as published on the EURD list for a given active substance or combination of active substances overrules the standard submission cycle i. Additionally, product information should be kept up-to-date by the MAH by submitting the appropriate variations taking account of the latest scientific knowledge or conclusions of assessments and recommendations made public by means of the EMA and national competent authority websites.

Since January it has become mandatory for new marketing authorisation, renewal and variation application submissions to be made using electronic application forms eAFs. Type IA change Type IA changes have little or no impact on the quality, safety or efficacy of the product, for example administrative modifications such as: In the latter case, a justification should be provided for the appropriate language s stating why certain comments are not reflected in the final texts. The PSUR should focus on summary information, scientific assessment and integrated benefit-risk evaluation. Clean PDF versions should have all changes ‘accepted’. Please note that late submissions can no longer be accepted once the procedure has started.

If a translation is considered not to be of an acceptable quality, the Member State concerned will inform the MAH and the Agency within 3 days of receipt of the translation.

Variation Procedure

The agreed changes should be included in the annexes of any subsequent regulatory procedures. The grounds for the re-examination request must be forwarded to the Agency within 60 days of receipt of the opinion. Guideline on good pharmacovigilance practices GVP: The EMA has published further guidance on how the fees are calculated and collected. 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.

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In this case no stand-alone RMP variation is necessary. In all other cases, varjation national competent authority chosen by the Coordination Group, taking into account the recommendation of the holder, will act as the ‘reference authority’. Worksharing procedure for multiple centrally authorised medicinal products ‘duplicates’.

cmdh variation cover letter template

For more information on how to use the PSUR repository, see: The EURD list facilitates the harmonisation of DLPs and frequency of submission of PSURs for medicinal products containing the same active substance or the same combination of active substances subject to different marketing authorisationsauthorised in more than one Member State. 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.

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.

Alternatively, such a listing may be provided as a separate document attached to the application form. Based on the evaluation of the cumulative safety data and the risk-benefit analysis, the marketing authorisation holder shall draw conclusions in the PSUR as to the need for changes to the product information of the products covered by the PSUR. Once MHRA has all the necessary documents, it takes up to 30 days to process your initial application.

Where at least one of the concerned marketing authorisations has been authorised via the centralised procedurethe Agency will be the ‘reference authority’. Start of the procedure according to the published timetable. See our pre-submission checklist PDF, 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 separate procedures.

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Heads of Medicines Agencies: Variation

Marketing authorisation holders are not required to systematically include listings of individual cases, including case narratives, in the PSUR. Once MHRA has all the documents, it will take days, reduced timetabletemplatte 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. Within the PSUR, the marketing authorisation coverr is required to consider the impact of the data and evaluations presented within the report, on the marketing authorisation.

cmdh variation cover letter template

Please refer to the guideline on the processing of renewals in the centralised procedure. Disagreements should be solved directly with the concerned MS.

Heads of Medicines Agencies: Variations

Is this page useful? A new procedure code abbreviation is used for worksharing procedures i. If the data contained in the PSUR contribute meaningfully to the scientific assessment, these data should be included in the scope of the PSUR procedure. Following analysis of submissions MHRA has developed a pre-submission checklist of submission errors.

Periodic safety update reports (PSURs)

The PSUR assessment under a PSUSA procedure is as follows, regardless whether it refers to one or more centrally authorised medicinal productsa mix of centrally authorised medicinal products and nationally authorised productsor nationally authorised products only. For groupings where MAs were granted through a national procedure only, you will need to apply for grouped changes through that respective member state.

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. The complete set of annexes must be presented sequentially i. See the CMDh variations procedure guidance for the details of this type of change.

Within 60 days from the receipt of the grounds for re-examinationthe CHMP will consider whether its opinion is to be revised. Upon finalisation of the review of the variations subject to the worksharing procedure, the Agency will issue an opinion reflecting the final outcome of the procedure.

Applicants are strongly advised to use the pre-submission checklist below which will reduce the likelihood of the submitted application being invalidated or rejected.