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. The MAH s will implement the required changes. These should take into account all EU authorised indications for products containing that active substance or combination of active substances. Veterinary regulatory Overview Research and development Marketing authorisation Post-authorisation. This affects all PSURs irrespective whether they are for centrally or nationally authorised medicinal products and whether they follow the EU single assessment or purely national PSUR procedure. 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.
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. The changes proposed to the labelling can be based on the reference product information. The EMA will check at the beginning of the procedure whether the submission of an RMP has been correctly performed in accordance to the above criteria. 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. 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. This is a legally binding requirement from the EU pharmaceutical legislation.
Guideline on good pharmacovigilance practices GVP: For centrally authorised products interim results not impacting on the product information or on the condition as stated in the Annex II of the marketing authorisation can be submitted as a post-authorisation measure PAM as described in question How and to whom shall I submit my PAM data see Post-authorisation measures: Skip to main content.
For more information on the EURD list and answers to frequently-asked-questions, see the following cmhd There may be some delay before EMA is able to respond due to the high volume of requests and necessary processing time.
Heads of Medicines Agencies: Renewals
The PSUR is not the appropriate procedure for submitting final or interim study reports to the EU regulatory authorities. Purely nationally authorised medicinal products mcdh considered those which contain substances or a combination of actives substances which are only authorised in one Member State. 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.
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. MAHs should contact the relevant Risk Management Specialist in case of such requests if there is a need for initial clarification on the process. A revised timetable will then be prepared.
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.
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. It should be noted that the PSUSA cut-off date continues to apply to procedures containing nationally authorised medicinal renswaland indicates the next upcoming start date for relevant submission deadlines in the EURD list.
PSUR repository mandatory use: In such case, only the amended parts of the SmPC and package leaflet should be provided in track changes and in English language under the EU regional appendix.
For more information on the EURD list and answers to frequently-asked-questions, see the following document:. Regarding centrally authorised letyerthe 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.
Of note, MAHs cannot use the information and data contained in the submissions for any other purposes than those related to the concerned procedure. PSURs and any related submissions using the existing file naming conventions are no longer possible.
Annex I scientific conclusions and grounds for variation to the terms of the marketing authorisations Annex II amendments to the product information of the nationally authorised medicinal products Annex III conditions to the marketing authorisationsas applicable Procedures that contain nationally authorised products NAP s Annex C: This affects all PSURs irrespective whether they are for centrally or nationally authorised medicinal products and whether they follow the EU single assessment or purely national PSUR procedure.
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.
For generic products or others not directly involved in the PSUSA procedure itself, the changes have to be submitted via a variation procedure according to the timelines indicated in the table below. For nationally authorised productsinterim results, if requested, need to be submitted to the relevant competent authority unless specified otherwise.
Such information and data will not be redacted from the single assessment report with respect to individual products prior to sharing them with all concerned MAHs. The EMA will check at the beginning of the procedure whether the submission of an RMP has been correctly performed in accordance to the above criteria. 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.
The contact information provided in the xml delivery file will always override any information provided in the cover letter.
Periodic safety update reports (PSURs)
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.
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 more information, see the questions-and-answers below and Periodic safety update report single assessments. You should type the full details of your query in the appropriate space.
The total of chargeable units in the procedure will be identified from the Art. The data presented in the submissions should be intended exclusively for the purposes of the concerned procedure. Whilst changes become binding 6 months after publication, there might 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.