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. Day 1 — 14 1 to 14 days after position: In case of CMDh position by consensus, Member States may perform a voluntary linguistic review in the translation process, therefore the following timelines apply: Of note, MAHs cannot use the information and data contained in the submissions for any other purposes than those related to 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. The use of key word ‘PSUR’ as a minimum in the subject line will help the Agency allocate your query to the correct person.
Leave this field blank. This is a legally binding requirement from the EU pharmaceutical legislation. For more details on how to submit amendments to the list, please refer to the EURD list cover note sections 2 and 5. This can result in having to submit a large number of sets of tracked change product information with the additional burden of providing translations. In cases where the wording has to be adapted, a type IB under category C. The list will then be amended accordingly when appropriate and published on the European medicines website. Once the translations are received from the MAH, the Agency will check if all Member States’ comments have been implemented.
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 explanatory note will form the basis of the upcoming revision of Cjdh VII; this update, once finalised, will therefore supersede this guidance document. Implementing variation needed, type and classification. In cases where the wording has to be adapted, a type IB under category C.
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 lettre of the Member States for nationally authorised products. There may be some delay before EMA is able to respond due to the high volume of requests and necessary processing time. Depending on the date of the EC decision on the revocation or withdrawal, or the date of expiry of the marketing authorization in case of non- renewalmarketing authorisation holders may still be required to submit a PSUR:.
Periodic safety update reports (PSURs)
Rnewal 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: 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.
Regarding centrally authorised productsthe marketing status should also be provided as a stand-alone report through the relevant mailbox and cmsh the dedicated template as indicated in the Rwnewal Post-authorisation Guidance on ‘marketing and cessation notification’ — What is the reporting format to the agency and to whom to report.
For more information on the EURD list and answers to frequently-asked-questions, see the following document: MAHs should translate all relevant Annexes for each procedure.
Expand section Collapse section. You should type the full details of your query reneawl the appropriate space. The regulatory activity ‘PSUR’ can only be used for the ‘initial’ PSUR submission due to the built-in business rules covee to the submission deadline. The PSUR should focus on summary information, scientific assessment and integrated benefit-risk evaluation.
Procedures that contain centrally authorised products CAP s. For more information, see: The submission should include a cover letter containing the following formatted table template to facilitate the registration of the submission.
CMDh best practic guide Purely nationally authorised medicinal products are considered those which contain substances or a combination of actives substances which are only authorised in one Member State.
Heads of Medicines Agencies: Applications for MA
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. MAHs should contact the relevant Risk Management Specialist in case of such requests if there is a need for initial clarification on the process.
For more information, see the questions-and-answers below and Periodic safety update report single assessments. The PSUR is not the appropriate procedure for submitting final or interim study reports to the EU lrtter authorities.
This aims to harmonise and strengthen benefit-risk review of medicines across the European Economic Area. The submission requirements for responses to requests for supplementary information are the same as those for the submission of the PSURs.
For generic cvoer 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 more lefter on GVP modules, see Good pharmacovigilance practices. Periodic safety update reports PSURs. For purely nationally authorised medicinal productscontaining substances or combination of actives substances not included in the EURD listfor which no PSUSA procedure has been established, the assessment of the PSURs will covwr at national level.
The contact information provided in the xml delivery file will always override any information provided in the cover letter. The MAH of centrally authorised medicinal products should submit a clean and a tracked version of the agreed amended product information prior to the adoption of the PRAC recommendation.
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. Veterinary regulatory Overview Research and development Marketing authorisation Post-authorisation.
PSURs of centrally authorised product s ; PSURs of any mix of centrally authorised products and tenewal authorised products including through the mutual recognition and decentralised procedures ; PSURs of nationally authorised products. The request and its grounds should be considered by the PRAC and the CHMP if it concerns at least one marketing authorisation granted in covwr with the centralised procedure or the CMDh otherwise, which will either approve or deny the request.