Start of the procedure according to the published timetable. An agreement on the procedural details of the PSUR submission should be reached between the marketing authorisation holder and the Agency. The explanatory note highlights and addresses challenges specific to the EU single assessment for nationally authorised products. For more information on the EURD list and answers to frequently-asked-questions, see the following document: The MAHs of such medicinal products should use alternative mechanisms such as signal management and emerging safety issues channels to communicate relevant new safety information to regulatory authorities see GVP Module VI and Module IX. In case of a CMDh position by consensus , the 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. PSURs are pharmacovigilance documents intended to provide an evaluation of the risk-benefit balance of a medicinal product at defined time points after its authorisation.
This deadline is legally binding and must be adhered to. The changes related to the use of ‘submission type’ and the new ‘submission unit type’ will be introduced to the PSUR repository in the next release of the PSUR Repository currently planned for July The timelines for assessment are for up to days followed by 67 days of Commission decision making process if applicable. The Agency uses this information to support the analysis of data, regulatory activities and communication. 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.
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A revised timetable will then be prepared. In the absence of a reply within two days, the EMA will assume that no oral explanation is requested. Skip to main content.
The frequency of submission shall be in accordance with the conditions specified in renewl marketing authorisation MAor otherwise according to the standard submission schedule of PSURs i.
In the latter case, a justification should be provided for the appropriate language s stating why certain comments are not reflected in the final texts.
This will, where appropriate, allow one single assessment of PSURs for products containing the same active substance. The list overrules the ‘standard’ PSUR submission cycle and any conditions related to the frequency of PSUR submission included lettter a marketing authorisation.
Information on the outcome of centrally authorised medicinal products is made available in the European Public Assessment Report EPAR page of the relevant medicine. For CMDh position by majority vote: 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.
This should be clearly discussed in both the conclusions and actions section of the body of the PSUR as well as in the EU regional appendix. At start of the procedure, the invoice will be sent to each MAH with the relevant chargeable units calculation. The submission requirements for responses to requests for supplementary information are the same as those for the submission of the PSURs.
Implementing variation needed, type and classification. If the above does not apply, the updated RMP should be submitted as a stand-alone variation. For generic products or others not directly reneeal 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 MAHs of such medicinal products should use alternative mechanisms such as signal management and emerging safety issues channels to communicate relevant new safety information to regulatory authorities see Eltter Module VI and Module IX.
Rneewal Agency uses this information to support the analysis of data, regulatory activities and communication. Where the procedure includes only NAPs, the procedure ends with the CMDh position in case of consensus and in case of a majority vote, the CMDh position will be followed by a Commission decision CD to the Member States, which respectively have to be implemented according to the timetable indicated in the CMDh position or within 30 days of the CD receipt by the Member States.
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: The clinical overview submitted in the renewal application should include relevant information to support the benefit-risk re-evaluation of the medicinal product.
The timelines for assessment are for up to days followed by 67 days of Commission decision making process if applicable.
Heads of Medicines Agencies: Renewals
For translations of Annexes QRD templates for each language should be used Make sure that the title pages are adjusted and all brackets i. The Agency will monitor the quality of the translations, the review by the Member States and industry’s compliance with the Member States’ ckver as part of the Performance Indicators. 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. Reference SME declaration Data submission for authorised medicines. The information and data contained in the individual submissions will be assessed and reflected in the single assessment report.
MAHs should translate all relevant Annexes for each 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. 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: 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 regulatory activity ‘PSUR’ can only be used for the ‘initial’ PSUR submission due to the built-in business rules linking to the submission deadline. The PSUR should focus on summary information, scientific assessment and integrated benefit-risk evaluation.