Please note that late submissions can no longer be accepted once the procedure has started. Worksharing procedure for multiple centrally authorised medicinal products ‘duplicates’. A PDF version of the entire post-authorisation guidance is available: You should pay the fee when you submit your variation to MHRA. Regarding centrally authorised products , the marketing status should also be provided as a stand-alone report through the relevant mailbox and using the dedicated template as indicated in the EMA Post-authorisation Guidance on ‘marketing and cessation notification’ — What is the reporting format to the agency and to whom to report. This form is a guide. This portal improves the efficiency of the technical support by allowing users to report issues, track progress of their queries and obtain answers to frequently asked questions.

Proposals for worksharing applications should be sent to:. Refer to the eCTD variations question-and-answer document for guidance on the submission of variations in eCTD format. MAHs should translate all relevant Annexes for each procedure. Where applicable changes in Word documents should be indicated using ‘Tools-Track Changes’. You can submit grouped changes to an MA with multiple product licences under the European procedure. This will allow all the involved Parties The Agency, MSs and Committee Members to receive the full data for the worksharing application. Such opinions will also list any variations e.

Periodic safety update reports (PSURs) | European Medicines Agency

Proposals for worksharing applications should be sent to: An agreement on the procedural details of the PSUR submission should be reached between the marketing authorisation holder and the Agency.

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.

However as the reference product information might be different for the various EU product informationit is essential that the MAH considers the proposed changes for the reference product information in the context of the different Cpver product information for the products covered by the submitted PSUR. Type-II variations listed templatee Article 23 1a varition may only be implemented once the Commission has amended the marketing authorisation and has notified the MAH accordingly.


Based on Articles 7 and 20 of the Variations Regulation, when a group of variations only consists of type-IA or -IA IN variations affecting several marketing authorisationsthis is considered as a ‘group’ of variations and not a ‘ worksharing ‘ procedure.

To help us improve GOV. Grouping applications for national MAs For groupings where MAs were granted through a national procedure only, you will need to apply for lettter changes through that respective member state. You can submit grouped changes to an MA with multiple product licences under the European procedure. After the translation process Once the translations are received civer the MAH, the Agency will check if all Cdh States’ comments have been implemented.

The request and its grounds should be considered by the PRAC and the CHMP if it concerns at least lstter marketing authorisation granted in accordance with the centralised procedure or the CMDh otherwise, which will either approve or deny the request. In the web form you will covsr asked to provide your name, the name of your employer or organisation, contact details and the subject of your enquiry.

Timeframe for submission of variation. The outcome of the PSUR assessment results in a legally binding decision or CMDh position and any action to vary, suspend or revoke the marketing authorisations must be implemented in a harmonised and timely manner for all products within the scope of the procedure across the EU. This should be clearly discussed in both the conclusions and actions section of the body of the PSUR as well as in the EU regional appendix. View all 15 ratings.

cmdh variation cover letter template

The submission requirements for responses to requests for supplementary information are the same as those for the submission of the PSURs. 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. Veterinary regulatory Overview Research and development Marketing authorisation Post-authorisation.


Where a worksharing application is considered invalid i. Alternatively, such a listing may be provided as a separate document attached to the application form.

Periodic safety update reports (PSURs)

An automated acknowledgement email is sent from the system confirming whether the submission has passed the relevant technical validation criteria and whether it has been uploaded to the Agency’s review tool and made available via the Common Repository. For more information, see: This form is a guide.

However, in exceptional cases where MAHs take the opportunity to introduce minor linguistic amendments in the texts e.

cmdh variation cover letter template

The letter of intent should provide the following information: Please refer to the guideline on the processing of renewals in the centralised procedure. A PSUR assessment can determine if further investigations on a specific issue are needed, or if an action is necessary to protect public health e. These should take into account all EU authorised indications for products containing that active substance or combination of active substances.

Of note, MAHs cannot use the information and data contained in the submissions for any other purposes than those related to the concerned procedure. Once MHRA has all the documents, it will take 30, 90 or days to assess your application depending on how urgent or complex the changes are, excluding time taken to answer questions.


An advice note will be generated at the data lock point DLP date and sent accordingly to the relevant QPPVs in order to ensure the accurate identification of the chargeable units for the products involved in the procedure. Home Health and social care Medicines, medical devices Marketing authorisations, variations and licensing guidance.

For more information, see the questions-and-answers below and Periodic safety update tejplate single assessments. It will take only 2 minutes to fill in.