Will fees be levied for scientific advice provided for PASS protocols? Is a pre-submission meeting always expected or can the MAH/Applicant choose not to have one? If the MAH(s) concludes that this is indeed the case, the MAH(s) should submit the results directly as an application for variation to the relevant competent authority. The final protocols for non-imposed PASS required by the PRAC can continue to be submitted to the PRAC as a Post-authorisation measure (PAM). In case of disagreement between a Member State and the MAH, EMA will not interfere in the translation process. More information on how to provide documents to the EU PAS Register for PASS studies can be found here: EU PAS Register. If the same safety concerns apply to more than one medicinal product, the relevant competent authority shall, following consultation with the PRAC, encourage the MAHs concerned to conduct a joint PASS (Article 10a(1)(a) of Regulation (EC) No 726/2004, Article 22a(1)(a) of Directive 2001/83/EC). assessment team from the same member state) or appointed as the PRAC peer-reviewer for a specific scientific advice procedure. Please see the published Employers may not ask about wage or salary history until after an offer of employment with compensation has been made. In addition, a linguistic review by Member States of these Annexes in all EU languages is performed after adoption of the CHMP opinion and CMDh position. In case of a joint PASS (i.e. EMA Guidance on Imposed Non-Interventional Post-Authorisation Safety Studies. As per Part II of the Annex to the Regulation EC No 658/2014, the fee for the assessment of PASS shall be paid in two instalments: The Agency does not levy a fee for the assessment of significant protocol amendments as defined in Article 107o of Directive 2001/83/EC. For technical queries related to the submission please contact us through the EMA Service Desk portal. Marketing-authorisation holders (MAHs) are obliged to carry out imposed PASSs. They aim to: PASSs can either be clinical trials or non-interventional studies. European Medicines Agency post-authorisation procedural advice for users of the centralised procedure; These questions and answers have been produced for guidance only and should be read in conjunction with the rules governing medicinal products in the European Union, volume 2, notice to applicants. In the absence of a reply within two days, EMA will assume that no oral explanation is requested. The use of key words in the subject line will help the Agency allocate your query to the correct person. can be completed and submitted. The timelines of the progress reports for a given study should be pre-specified and indicated in the protocol. Depending on the type of outcome and whether an EC Decision is required (i.e. Based on the results of the study and after consultation with the MAH(s), the PRAC may make recommendations concerning the marketing authorisation. A face to face discussion meeting with the MAH/Applicant and members of the SAWP is held the following month (See figure 1 below SAWP 3). 1 Council Regulation (EC) No 297/95 on fees payable to the European Medicines Agency, 2Rules for the implementation of Council Regulation (EC) No 297/95 on fees payable to the European Medicines Agency and other measures EMA/MB/530034/2014. You will be able to contact this RMS throughout the procedure. Following the discussion meeting with the MAH/Applicant, and further to the SAWP plenary discussion, the SAWP Coordinators issue a draft joint report for comments by the involved participants. Translation of the adopted Annexes in EN and in all other EU languages (and in Icelandic and Norwegian) are to be compiled and provided electronically (in one Eudralink package if applicable) to the EMA procedure assistant. They include non-imposed studies that are requested in risk management plans. Following experience gained from the scientific advice PASS pilot phase, scientific advice is encouraged to be sought for non–imposed PASS i.e. submission to NCA for nationally authorised products or to EMA for centrally authorised products). Harmonized guidance for eCTD submissions in the EU, Timetables for non-interventional imposed PASS protocols and results, Guideline on good pharmacovigilance practices (GVP) Module VIII - Post-authorisation safety studies, Guidance to applicants /marketing authorisation holders (MAHs) on oral explanations at EMA, Member States (MS) Contact Points for Translations, Product Information: Reference documents and guidelines, List of Member States contact points for translations (with guidance on the sending of product information to Member States), User guide on the preparation of PDF versions of the product information, EC Guideline on the operation of the procedures laid down in Chapters II, III and IV of Commission Regulation (EC) No 1234/2008 of 24 November 2008, Question Answers, Pharmacovigilance legislation, Q/A-LIST FOR THE SUBMISSION OF VARIATIONS ACCORDING TO COMMISSION REGULATION (EC) 1234/2008, The European Union electronic Register of Post-Authorisation Studies (EU PAS Register), Outcomes of imposed non-interventional post-authorisation safety studies, Pharmacovigilance fees payable to the European Medicines Agency, Pharmacovigilance fees: questions and answers. Scientific guidance on post-authorisation efficacy studies ENCePP Plenary Meeting, 22 November 2016 Presented by Kevin Blake D-SSD-CPN EMA . User Guidance for Marketing Authorisation Holders (MAH) EMA/346582/2016 v. 2.15 Page 5/77 Version Date Changes applied Author 2.10 28/02/18 Updated to reflect changes introduced in v3.4. This is without prejudice that a variation as appropriate should be submitted should these interim results lead to product information changes or RMP changes. For CAPs, the PRAC Rapporteur will be the one already appointed for the product. A further PRAC peer-reviewer is appointed to provide additional product specific PRAC input. QRD Convention question & answers as published in the post-authorisation guidance for access to the hyperlinked . For NAPs, further guidance on implementing variation can also be found on the CMDh website (Question Answers, Pharmacovigilance legislation). EMA publishes the outcomes of final study results of non-interventional imposed post-authorisation safety studies (PASS) for NAPs on the EMA website. questions on pre-marketing and post-marketing phases, or questions on PASS and pivotal phase III studies, or questions on interventional and non-interventional studies? fees query form 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 EC decision to the Member States, which will 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. A pre-submission meeting with Agency staff will be arranged to consider the suitability and validity of the submission. The Agency will monitor the quality of the translations, the review by the Member States and MAHs' compliance with the Member States' comments as part of the Performance Indicators. For any remaining question, the dedicated EMA . The guideline is primarily aimed at marketing authorization applicants and holders planning to conduct registry studies in the pre- or post-marketing authorization phase. Please give as much detail as possible when completing your request and be sure to include your correct and complete contact details. Where can I find further information about scientific advice? format, layout and margins). Applicants/MAHs wishing to request scientific advice on specific aspects of PASS protocols /or joint protocols by a consortium of MAHs for PASS imposed as conditions to the marketing authorisation (i.e category I and II PASS), can also submit a SA request. If a translation is considered not to be of an acceptable quality, the Member State concerned will inform the MAH and the Agency within 3 days of receipt of the translation. on how the fees are calculated and collected. Any response to a request for supplementary information must be sent to EMA, the PRAC Rapporteur and all PRAC members as per above requirements. 2. Could questions be asked about the choice of the adverse reactions of interest? Once the translations are received from the MAH, the Agency will check if the comments received from Member States' have been implemented. The draft package should be presented in line with published template for scientific advice. the category III PASS. What about non-imposed PASS protocols required to be submitted by the PRAC that have not been through an EMA scientific advice procedure? . The MAH or Applicant provides questions and an accompanying justification of the approach taken with the relevant introduction, background, annexes and references. (e.g. The MAHs are also strongly advised to liaise directly with the Member States in case of disagreement with any of the comments made or in case further clarification on some comments is required, and to reflect the outcome in “ In this context, two different types of scientific advice fees are applied depending on whether the request is an 'initial request' or a 'follow-up'. After a study has commenced, the MAH has to submit any substantial amendment to the protocol, before its implementation, for review and endorsement by PRAC. However, some MAH/Applicant can choose not to request one. The update addresses recent changes regarding marketing and cessation notification requirements and the sunset clause. Expertise in pharmacoepidemiology needed to evaluate PASS protocols, is available through the extension of the SAWP currently to 2 joint SAWP - PRAC delegates who can also act as SAWP coordinators for a specific scientific advice product procedure. Sections should not be left out and Annex III should not be updated, e.g. The responsibility to communicate with the rest of the participants in the joint study lies with the appointed contact person as per the specific contractual arrangements among MAHs. EMA has recently revised a part of these Q&A concerning the procedure under which MAHs should submit post-authorisation measures and how they should structure the submission dossier. The format of non-interventional imposed PASS protocols and final study reports (Articles 107n-q of Directive 2001/83/EC) is provided in Annex III of Commission Implementing Regulation (EC) No 520/2012. Imposed non-interventional PASS final study reports should be submitted in module 5.3.6 of the CTD. For centrally authorised medicinal products (CAPs) the change of the due date of the corresponding condition to the marketing authorisation (MA) will require a change to Annex II of the marketing authorisation via a variation application. 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