In case of comments, it will be up to the MAH to correctly implement the same amendments in the other centrally authorised products , as appropriate. A shorter presubmission phase is envisaged in cases where: All the other variations will follow a yearly timeframe for update of the respective Commission decision. After the translation process Once the translations are received from the MAH, the Agency will check if all Member States’ comments have been implemented. Upon receipt of a favourable CHMP opinion that requires amendments to the decision granting the marketing authorisation , the 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.
For CMDh position by majority vote: 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. Expand section Collapse section. Marketing-authorisation-updating process for nationally authorised medicinal products if applicable. For more information, see: The Agency will inform the MAH of the insufficient quality of the translations and the transmission to the Commission will be delayed until receipt of the amended translation which would be expected within 1 week. 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.
Periodic safety update reports (PSURs) | European Medicines Agency
In cases where the wording has to be adapted, a type IB under category C. 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.
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.
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.
Marketing authorisation holders are not required to systematically include listings of individual cases, including case narratives, in the PSUR. 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.
Worksharing: questions and answers | European Medicines Agency
Schematic structure of the CHMP opinion and annexes for an application under worksharingconsisting of centrally and nationally authorised medicinal products: 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 rapporteursRMSs and national competent authorities, as applicable, as well as an overview of the submission format for the different products, if applicable e.
This aims to harmonise and strengthen benefit-risk review of medicines across the European Economic Area. The submission should include a cover letter containing the following formatted table template to facilitate the registration of the submission. Skip to main content. Only one centrally authorised medicinal product reewal undergo a linguistic check.
For queries relating to the presentation of the application, please contact the Agency. An agreement on the procedural details of the PSUR submission should be reached between the marketing authorisation holder and the Agency.
Revised topics are marked ‘New’ or ‘Rev. In this communication the MAH should indicate whether they would wish to make use of the opportunity of an oral explanation oetter defend their position before the PRAC.
MAHs or national competent authorities can request the inclusion of the fixed combination in the EURD list for reasons temmplate to public coved, in order to avoid duplication of assessment or in order to achieve international harmonisation.
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.
Periodic safety update reports (PSURs)
MAHs must in all cases comply with the requirements of Community legislation. It is the responsibility of the marketing authorisation holder to check regularly the list of EU reference dates and frequency of submission published in letger European medicines web-portal to ensure compliance with the PSUR reporting requirements for their medicinal products.
Subsequently, where the procedure includes at least one CAP, the Commission will adopt a decision to the MAHs for the centrally authorised products and, as applicable, to the competent authorities of the Member States for nationally authorised products. Purely national marketing authorisations can be included in worksharing procedures submitted as of 4 August In this case no stand-alone RMP variation is necessary. 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.
It should be presented as a tracked change version of each EU SmPCs and package leaflets of the products concerned and each product information should be translated into English language including the tracked changes proposed, in order to enable the EU single assessment. However, they shall provide case narratives in the relevant risk evaluation section of the PSUR where integral to the scientific analysis of a signal or safety concern in the relevant risk evaluation section.
Human regulatory Overview Research and development Marketing authorisation Post-authorisation Herbal products.
In order to benefit from a worksharing procedure, it is required that the lftter changes will apply to the different medicinal products concerned, with either no or limited need for assessment of a potential product-specific impact. Variations related to safety issues, including urgent safety restrictionsmust be implemented within a timeframe agreed by the marketing authorisation holder and the Agency.
Any amendment to the EURD list becomes effective six months after its publication. In order to avoid duplication of work in the evaluation of such variationsa worksharing procedure has been established under which one authority the ‘reference authority’chosen amongst the competent authorities of the Member States and the Agency, will examine the variation on behalf of the other concerned authorities.
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.
Quality Changes to the active-substance master file. However PSURs should be submitted as specified in the conditions of the marketing authorisation for the combination product if anyor otherwise according to the standard submission cycle i. Alternatively, such a listing may be provided as a separate document attached to the application form.