If the above does not apply, the updated RMP should be submitted as a stand-alone variation. Variations related to safety issues, including urgent safety restrictions , must be implemented within a timeframe agreed by the marketing authorisation holder and the Agency. Also see ‘when do I have to submit revised product information? Refer to the eCTD variations question-and-answer document for guidance on the submission of variations in eCTD format. For such procedures, a linguistic review will take place in parallel to the scientific assessment. Veterinary regulatory Overview Research and development Marketing authorisation Post-authorisation.
Any information included in this section, will be discussed by the CMDh for nationally authorised products with the aim of agreeing on any necessary action, which will then be transmitted to MAHs either in the CMDh minutes or as a press release dependent on the issue. PSUR repository mandatory use: Do not leave sections out, do not update the Annex III, e. The list overrules the ‘standard’ PSUR submission cycle and any conditions related to the frequency of PSUR submission included in a marketing authorisation. In case no changes to the product information are being proposed as part of the PSUR, the MAH should not include any product information within the EU regional appendix.
Heads of Medicines Agencies: Variations
A shorter presubmission phase is envisaged in cases where: View all 15 ratings. Changes to a single-substance MA and a fixed-combination MA containing the same active substance. Following an expression of interest and based on a rota system, the Chair of the Committee for Medicinal Products for Human Use CHMP will appoint a rapporteur and co-rapporteur when the application includes a new indication for the procedure.
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. If the contact details you provide are incomplete or inaccurate this may prevent the Agency from communicating with you. For nationally authorised products NAPsplease submit your query using the following web form. Standards of translation of Annexes The structure of the English Annexes has to be strictly followed and should be exactly translated as per the adopted English version i.
European Medicines Agency post-authorisation procedural advice for users of the centralised procedure These questions and answers have been produced for guidance only and should be read in conjunction with the rules governing medicinal products in the European Union, volume 2, notice to applicants.
This portal improves the efficiency of remplate technical support by allowing users to report issues, track progress of their queries and obtain answers to frequently asked questions. One original cover letter fenewal 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 rapporteursRMSs and national competent authorities, as applicable, as well as an overview of the submission format for the different products, if applicable e.
Applications for Marketing Authorisation
The details of the applicant where the invoice should be sent to should be clearly stated in the cover letter. To further facilitate cmch check and assessment, the MAH should present clean and tracked changes Word versions of the RMP in the submission. Complete set of annexes of one CAP electronically only in Tempkate format highlighted.
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.
In this communication the MAH should indicate whether they would wish to make use of the opportunity of an oral explanation to defend their position before the PRAC. Questions and answers relating to practical and technical covef of the implementation and the eSubmission Gateway web client: Do not leave sections out, do not update the Annex III, e.
Ocver procedure for type-II variations At submission day 0: It ccover be noted that the PSUSA cut-off date continues to apply to procedures containing nationally authorised medicinal productsand indicates the next upcoming cmxh date for relevant submission deadlines in the EURD list. Article 23 1a a provides for a two-month timeframe for amending the decision granting the marketing authorisation for the following variations:.
A PDF version of the entire post-authorisation guidance is available: For more information on the EURD list and answers to frequently-asked-questions, see the following document: The use of key word ‘PSUR’ as a minimum in the subject line will help the Agency allocate your query to the correct person. Marketing Authorisation Holders are advised to submit such variations as usual.
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National competent authorities can also request PSUR for generic medicinal products at any time on the grounds detailed in Article c 2 of the Directive. However, in exceptional cases where MAHs take the opportunity to introduce minor linguistic amendments in the texts e. Marketing-authorisation-updating process for nationally authorised medicinal products if applicable.
Heads of Medicines Agencies: Renewal
MAHs should contact the relevant Risk Management Specialist in case of such requests if there is a need for initial clarification on the process. 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.
Supporting documentation for each product including the revised summary of product characteristicslabelling and package leafletif applicable. Periodic safety update reports are pharmacovigilance documents intended to provide a safety update resulting rsnewal an evaluation of the impact of the reports on the risk-benefit balance of a medicinal product.
Applicants must not send any accompanying hard media or separate paper cover letter as the cover letter will be in the relevant part of eCTD module 1 in PDF format. A formal letter with the worksharing applicant and contact person for the worksharing procedure should be provided with the worksharing application.
The changes related to the use of lettre type’ and the cdh ‘submission unit type’ will be introduced to the PSUR repository in the next release of the PSUR Repository currently planned for July