COVER LETTER PSUR EMA
Please note that late submissions can no longer be accepted once the procedure has started. Procedures that contain centrally authorised products CAP s. 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 CMDh position by majority vote: Day days after position The MAH s will implement the required changes. This can result in having to submit a large number of sets of tracked change product information with the additional burden of providing translations.
Leave this field blank. The frequency of submission shall be in accordance with the conditions specified in the marketing authorisation MA , or otherwise according to the standard submission schedule of PSURs i. At start of the procedure, the invoice will be sent to each MAH with the relevant chargeable units calculation. The Agency uses this information to support the analysis of data, regulatory activities and communication. For more information on the EURD list and answers to frequently-asked-questions, see the following document:. These should take into account all EU authorised indications for products containing that active substance or combination of active substances. Start of the procedure according to the published timetable.
In case of incomplete or incorrect data in the web form, the request may not be processed.
Heads of Medicines Agencies: Variations
For nationally authorised medicinal products i. This format is a legal requirement for both nationally authorised products and centrally authorised products.
Annex I – Definitions. For more information, see: 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 on GVP modules, see Good pharmacovigilance practices. For CMDh position by majority vote: 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.
This aims to harmonise and strengthen benefit-risk review of medicines across the European Economic Area. The Agency will monitor the quality of the translations, the review by the Member States and industry’s compliance with the Member States’ comments as part of the Performance Indicators.
An agreement on the procedural details of the PSUR submission should be reached between the marketing authorisation holder and the Agency. 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. Points highlighted in this document may nevertheless also apply to the assessment of centrally authorised products and hence it is recommended that all MAHs consult the document prior to finalisation of their PSUR.
The official contact person for the PSUR procedure is the one provided in the xml delivery file. 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. For more information on letyer EURD list and answers to frequently-asked-questions, see the following document:. The PSUR is not the appropriate procedure for submitting final or interim study reports to psuf EU regulatory authorities.
Periodic safety update reports (PSURs)
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.
Before submitting a request, EMA encourages stakeholders to carefully consult the Introductory cover note. 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.
They, however, remain part of the Commission Decision in the Community Registry on the Commission’s webpage. Standards of translation of Annexes The structure of the English Annexes has to be strictly followed covr should be exactly translated as per the adopted English version i. If a translation is considered not to be of an acceptable quality, the Covet State concerned will inform the MAH and the Agency within 3 days of receipt of the translation.
It should be presented as a tracked change pshr of each EU SmPCs and package leaflets of the products concerned and each product information should lehter translated into English language including the tracked changes proposed, in order to enable the EU single assessment. The list overrules the ‘standard’ PSUR submission cycle and any conditions related to the frequency of PSUR submission included in a marketing authorisation.
For more details on PSUR submissions for generics, products containing well-established substances, homeopathic or herbal medicinal productsplease refer to the question Do I have to submit a PSUR my medicinal product if it is a generic, a product containing a well-established substance, a homeopathic or herbal medicinal product?
The share payable by each marketing authorisation will be calculated by the EMA. The timelines for assessment lettre for up to days followed by 67 days of Commission decision making process if applicable. However, the parallel importer will not become party to the PSUR procedure and will not receive a copy of the assessment report and outcome documentation as a MAH would.
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. Regarding centrally authorised productsthe 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.
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.
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 emw be required to submit a PSUR: Day days after position The MAH s will implement the required changes.