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. 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. The objective of the PSUR is to present a comprehensive and critical analysis of the risk-benefit balance of the product, taking into account new or emerging safety information in the context of cumulative information on risk and benefits. 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. Do not leave sections out, do not update the Annex III, e.
Use of the PSUR repository is mandatory for both centrally and nationally authorised medicines, whether they follow the EU single assessment or a purely national assessment procedure. It is important that changes proposed to the product information which are based on the submitted PSUR data are not submitted in parallel via a separate variation procedure. 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: Purely national marketing authorisations can be included in worksharing procedures submitted as of 4 August The worksharing application must be submitted at the same time to all relevant authorities, i. 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 submission should include a cover letter containing the following formatted table template to facilitate the registration of the submission.
For more information on how to use the PSUR repository, see: Information on the outcome of centrally authorised medicinal products is made available in the European Public Assessment Report EPAR page of the relevant medicine. The PSUR is not the appropriate procedure for submitting final or interim study reports to the EU regulatory authorities.
Use of the PSUR repository is mandatory for both centrally and nationally authorised medicines, whether they follow the EU vover assessment or a purely national assessment procedure. Introduction or changes to the pharmacovigilance system. 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.
The explanatory note will form the basis of the upcoming revision of GPV VII; this update, once finalised, will therefore supersede this guidance document. An agreement on the procedural details of the PSUR submission should be reached between the marketing authorisation holder and the Agency. The data presented in the submissions should be intended exclusively for ketter purposes of the concerned procedure. For these active substancesthe frequency of submission is established at national level.
Such opinions will also list any variations e. Once the translations are ccmdh from the MAH, the Agency will check if all Member States’ comments have been implemented.
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.
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.
If the variations subject to worksharing affects the summary of product characteristics SmPClabelling or package leafletthe revised product information annexes must be submitted as follows:.
The explanatory note highlights and addresses challenges specific to the EU single assessment for nationally authorised products. A template cover letter for worksharing procedures including centrally authorised products and nationally authorised products only is available.
Heads of Medicines Agencies: Applications for MA
Where the proposed changes are not based on the data submitted within the PSUR, these will not be considered and a variation will have to be submitted as appropriate to the relevant national competent authority. If nationally authorised medicinal products are part of the worksharing procedure, the MAH should also include a confirmation that the worksharing applications have been submitted to all Member States where the products concerned are authorised and that the relevant national fees have been paid.
Marketing Authorisation Holders are advised to submit such variations as usual. For more details on how to submit amendments to the list, please refer to the EURD list cover note sections 2 and 5. 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.
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. Human regulatory Overview Research and development Marketing authorisation Post-authorisation Herbal products. Clean PDF versions should have all changes ‘accepted’.
In case of a CMDh position by consensusthe Agency will compile the Annexes in all languages, send the final copies to the Member States and, where applicable, the full set of Annexes will be published on the EMA website.
Submission to the Rapporteur and Committee members.
Applications for Marketing Authorisation
PSUR repository mandatory use: How useful was this page? For purely nationally authorised medicinal productscontaining substances or combination of actives substances not included in the EURD teemplatefor which no PSUSA procedure has been established, the assessment of the PSURs will remain at national level. These should take into account all EU authorised indications for products containing that active substance or combination of active substances.
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. For a civer overview of dossier requirements for National Letted Authorities of Co- Rapporteur and Committee members, including delivery addresses, please refer to the following document: PSURs are pharmacovigilance documents intended covre provide an evaluation of the risk-benefit balance of a medicinal product at defined time tempate after its authorisation.
Submission to the National Competent Authorities 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. MAHs or national competent authorities can request the inclusion of the fixed combination in the EURD list for reasons related to public health, in order to avoid duplication of assessment or in order to achieve international harmonisation.