psur submission timelines

always required . for provisional registration products, black triangle products, biosimilars and for vaccines.

Periodic Safety Update Report (PSUR) Dr. Rohith K Nair 2. The legislation introduces derogation for routine PSUR reporting for certain products. A Periodic Safety Update Report is a pharmacovigilance document intended to provide an evaluation of the risk-benefit balance of a medicinal product at defined time points post-authorisation. Unless there is a specific condition in the authorisation, or it is indicated otherwise in the EURD list, routine PSUR reporting is not required for medicinal products authorised under the following articles of Directive 2001/83/EC:All PSURs should be submitted to the PSUR repository using the eSubmission Gateway/Web Client: Information on the repository, guidance on how to register and multimedia tutorials for MAHs on how to submit a PSUR, as well as on the correct structured electronic formats, can be found on EMA’s PSUR repository web pages here: Further information for MAHs on changes to submission of PSURs for human medicines is available here: Users of the repository should direct any questions on use of the EMA PSUR repository and/or the eSubmission Gateway/Web Client to the EMA Service Desk portal: For further information on submission dates, PSUSA procedure number and requirements for submission of products referred to in articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended please refer to the Detailed guidance on procedural aspects of the EU single assessment is available on the EMA website: Kevin O'Malley House, Earlsfort Centre, Earlsfort Terrace, Dublin 2, Ireland, D02 XP77 PSUR submission . Template - PSUR Assessment Report; Template - Lead Member State PSUR Follow-Up assessment report ; The United Kingdom (UK) withdrew from the European Union (EU) on 31 January 2020 and is no longer an EU Member State. By using this website, you consent to the use of cookies in accordance with the HPRA Cookie Policy. Marketing Authorisation Holders (MAHs) are required to submit PSURs according to the data lock points published in the EURD list.
Information on the latest approved ICH E2E / RMP documentation is now requested under «Supplementary documents submitted» and redundant administrative information has been removed from the form. The concept of the project was that substances would have harmonised birthdates allowing MAHs to submit PSURs for products containing the same substance to NCAs at … It also facilitates the assessment by ensuring that NCAs, EMA and its scientific committees have timely and secure access to all relevant documents.

If there are “substitutions” in the waiver (e.g. HMA and CMDh/v are in the process of making appropriate changes to this website. MU103_10_002e_FO Form PSUR/PBRER … (GVP ModuleVII) • Periodic Safety Update Report (PSUR) 1. The European Medicines Agency maintains a list of EU reference dates and frequency of submission of PSURs (EURD list) for active substances contained in medicines in the EU and is updated on an ongoing basis.Marketing Authorisation Holders (MAHs) are required to submit PSURs according to the data lock points published in the EURD list. This release provides minor changes to the MAH and NCA user interfaces, new features for EMA users and number of new notifications for all users.

Definition • Periodic safety update reports (PSURs) are pharmacovigilance documents intended to provide an evaluation of the risk-benefit balance of a medicinal product for submission by marketing authorisation holders at defined time points during the post- authorisation phase. So in this guidance, FDA indicates that if a company/sponsor/applicant already has an old style PSUR waiver they do not need to submit a new waiver request. PSUR Repository user registration form for NCA usersEudraVigilance system downtime – impact on PSUR Repository and the eAFAutomated two-way exchange of documents held in the PSUR Repository between NCA systems and the PSUR Repository to reduce administrative burden for NCAs .Please note that procedural questions on non-EU single assessment procedures conducted only in one Member State must be addressed to the relevant National Competent Authority.
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.The 2010 legislation introduces the principle of EU single assessment where a substance is authorised in more than one Member State. The «PSUR/ PBRER for human medicines HMV4» form has been updated. The PSUR Repository provides an important simplification for marketing authorisation holders allowing them to send all PSURs and related submissions to a single recipient. The PSUR repository is a single, central platform for PSURs and related documents to be used by all regulatory authorities and pharmaceutical companies in the EU. The PSUR Repository was introduced by the EU pharmacovigilance legislation to facilitate the exchange of information on the safety of authorised medicines between regulators and pharmaceutical companies and it supports both the PSUR Single Assessment Procedure (PSUSA), as governed by the PSUR submissions to the Repository are made using the An updated version of the PSUR Repository (v1.17.0.0) is now available. HMA and CMDh/v are …

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