Member States will send linguistic comments on the Annexes to the MAH by e-mail with a copy to the Mailbox. These progress reports may include available interim results, but there is in general no obligation or recommendation to include interim results in RMPs unless required as part of an agreed pharmacovigilance plan. EudraVigilance is also one of the main pillars of the European Risk Management Strategy , a joint effort between the EMA and NCAs to strengthen the conduct of pharmacovigilance in the EEA. Feedback on whether questions can be validated as posed or reworded will be given at the validation stage. QRD Convention Terminology) should be applied. 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. The rules governing non-interventional imposed PASS are set in Articles 107n-q of Directive 2001/83/EC. How do I apply for scientific advice on a PASS protocol? What about non-imposed PASS protocols required to be submitted by the PRAC that have not been through an EMA scientific advice procedure? QRD Form 2 NEW May 2017. The revised product information of the product(s) concerned should be presented in English language in module 1.3. In stark contrast, the EMA guidance stipulates the only alternative is a co-primary endpoint that has both resolution of NASH and improvement in fibrosis. The latest PDF letter of Intent form provided on the EMA scientific advice website should be used. Upon completion of the study, the MAH has to submit a final study report within 12 months of the end of data collection to the PRAC (Article 107p of Directive 2001/83/EC). Does EMA expect all PASS studies to go through scientific advice? The EMA highlights in the guidance document that the … The SAWP Coordinators will then draft preliminary reports in response to the scientific advice or protocol assistance requests taking into account the timetable for evaluation of such requests.In addition to the SAWP coordinators and the joint PRAC SAWP delegate, a PRAC peer-reviewer is appointed to follow the procedure. Subsequently, where the procedure includes at least one CAP, the EC 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. The timelines for assessment are 60 days, the following timetable shall apply: Start of the procedure according to the published timetable, PRAC Rapporteur's preliminary assessment report, PRAC Rapporteur's updated assessment report (if necessary). Non-interventional imposed PASS will be assessed by the Pharmacovigilance Risk Assessment Committee (PRAC), except for studies to be conducted in only one Member State requesting the study according to Article 22a of Directive 2001/83/EC. MGL c.149 Labor and industries.Numerous sections throughout this chapter apply to the hiring process. . Submissions of joint PASS follow the same requirements as single studies. They aim to: PASSs can either be clinical trials or non-interventional studies. Following the assessment and conclusion of the procedure, outcomes endorsing changes to the timelines on the submission of such final study results will be made public on the dedicated EMA webpage on PASS outcomes. In case of incomplete or incorrect data in the web form, the request may not be processed. . A further PRAC peer-reviewer is appointed to provide additional product specific PRAC input. Who will assess the PASS protocols for SAWP? submission to NCA for nationally authorised products or to EMA for centrally authorised products). At the time of imposition of the study by the PRAC, EMA will support interactions between the MAHs concerned by sharing contact details among those that wish to participate in a joint study. guidance Protocols or synopses, SmPCs, Risk Management Plans and assessment reports pertinent to the topic should be annexed as appropriate. How do I prepare for a Discussion meeting? Post-authorisation The European Medicines Agency (EMA) provides scientific and regulatory guidance to pharmaceutical companies whose medicinal products have been authorised in Europe. A post-authorisation safety study (PASS) is a study that is carried out after a medicine has been authorised to obtain further information on a medicine's safety, or to measure the effectiveness of risk-management measures. The MAH/Applicant may also propose in writing to the Agency additional points for discussion that are not part of the adopted list of issues and submit these in writing ahead of the Discussion meeting. These questions and answers (Q&As) provide an overview of the European Medicines Agency's (EMA) advice on issues that are typically addressed in discussions or meetings with marketing authorisation holders in the application phase.. They should only be included as an annex to the risk management plan (RMP), once they are endorsed by PRAC, at the next regulatory opportunity. Last week, European Medicines Agency (EMA) updated the guidance document “ European Medicines Agency post-authorisation procedural advice for users of the centralised procedure ”. EMA will organise a second public meeting on 8 January 2021 to inform European citizens about the assessment, approval and roll-out of new COVID-19 vaccines. QRD Form 2 Procedures for PASS protocols will not be handled any differently than for existing scientific advice procedures except the extension to and inclusion of PRAC interactions and relevant Agency staff, such as the Risk Management Specialist. Information about post-authorisation activities completed prior to 31 December 2020 will remain available on the EMA website. Day 25 (25 days after opinion / position). Further details on routine 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. 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. For pre-submission queries that are not covered by this guidance please submit your query using the following web form. 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. An EU competent authority may impose a non-interventional PASS, either as a condition of marketing authorisation (category 1) at the moment of granting the marketing authorisation or in the post-authorisation phase, or as a specific obligation in a conditional marketing authorisation or a marketing authorisation under exceptional circumstances (category 2). This is without prejudice that a variation as appropriate should be submitted should these interim results lead to product information changes or RMP changes. To enable this publication to take place, MAHs should register their PASSs in the European Union electronic Register of Post-Authorisation Studies (EU PAS Register). Two SAWP members/alternates are appointed as coordinators for each scientific advice procedure. the possibility of seeking follow up advice. Any additional copies should not be submitted directly to the NCAs on CD/DVD or via CESP as this might lead to validation issues and cause delays. several marketing authorisation holders working together to conduct the PASS), the total amount of the fee will be divided equally among all the marketing authorisation holders concerned. first instalment (40%) for the assessment of the draft protocol (Article 107n of Directive 2001/83/EC); second instalment (60%) for the assessment of the final study report by the, a lifecycle approach to medicines advice with integrated advice on all aspects of medicines development from involved Committees, advice at an early or late stage of the protocol development, a pre-submission interaction with Agency secretariat to consider suitability and validity of the dossier, a face to face meeting with involved regulators during the procedure, options to include other stakeholders such as HTAs or FDA further supporting optimised evidence generation. In the web form you will be asked to provide your name, the name of your employer or organisation, contact details and the subject of your enquiry. The timelines for assessment are for up to 74 days followed by 67 days of European Commission (EC) decision making process (if applicable). A post-authorisation safety study (PASS) is defined in Article 1(15) of Directive 2001/83/EC as “any study relating to an authorised medicinal product conducted with the aim of identifying, characterising or quantifying a safety hazard, confirming the safety profile of the medicinal product, or of measuring the effectiveness of risk management measures”. For imposed PASSs, the PRAC assesses the study protocol and the outcomes of these studies as given in the final study report. The clock will be stopped until the receipt of the requested supplementary information. User Guidance for Marketing Authorisation Holders (MAH) EMA/346582/2016 v. 2.15 Page 7/80 pam-leg Legally binding measure related to a post-authorisation measures Protocols and protocol amendments (Articles 107n-o). 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). 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. A RMP update can also be submitted with a final PASS study report for single centrally authorised medicinal product or a mixture of CAPs belonging to the same global marketing authorisation (GMA) when the changes to the RMP are a direct result of data presented in the study report. The MAH(s) will implement the required changes. For clinical trials, MAHs should follow the instructions in volume 10 of the rules governing medicinal products in the European Union (EU). Feedback on whether the MAH or Applicant's draft questions can be validated as posed or reworded will be given at the validation stage. 60 days after publication of EC decision on EC website. Marketing-authorisation holders (MAHs) are obliged to carry out imposed PASSs. 1051 calendar days after adoption of the CMDh position (see Question 10). A pre-submission meeting with Agency staff will be arranged to consider the suitability and validity of the submission. on how the fees are calculated and collected. MAHs with marketing authorisations in Iceland and/or Norway will provide translations in these languages as well. In addition, Annex III of Commission Implementing Regulation (EC) No 520/2012 specifies that the final study report of imposed non-interventional PASS must provide the date of registration in the EU PAS Register. For further details on fees and fee incentives/reductions please consult the Explanatory Note on fees payable to the EMA and the section on fees on the Agency's website. What is the role of the PRAC within the scientific advice procedure for PASS protocols? Points of interest April 2014 Delegated Regulation, 1st PAES imposed CHMP June 2014 ) ... European Medicines Agency Keywords: The PRAC will endorse the advice relating to PASS, and a Final Advice Letter will be issued. After this deadline, the Agency will contact MAH(s) to make sure the information is available in the register and, unless alternative timelines are agreed, will enter the information on its own initiative in order to fulfil its legal obligations under Article 26(1)(h) of Regulation (EC) No 726/2004. SAWP will report to PRAC at each phase of the procedure. 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. Please give as much detail as possible when completing your request and be sure to include your correct and complete contact details. Protocols and public abstracts of results of imposed non-interventional PASS are publicly available in the EU PAS Register on the European Network of Centres in Pharmacoepidemiology and Pharmacovigilance (ENCePP) website. EMA scientific advice guidance The European Medicines Agency (EMA) has published new draft guidelines on registry-based studies ... providing data sources or infrastructure for post-authorisation evidence generation: ... EMA is hosting a virtual workshop on 19 October 2020 to present the draft guideline to key stakeholders. The MAH or Applicant provides questions and an accompanying justification of the approach taken with the relevant introduction, background, annexes and references. Please refer to the individual . For CAPs, the PRAC Rapporteur will be the one already appointed for the product. You should type the full details of your query in the appropriate space. Post-Authorisation; Guidance Documents ... (ICSRs)' (EMA/H/20665/04/Final Rev. EMA is in the process of making appropriate changes to this website. Of note, products that are not involved directly in the procedure (i.e. Importantly, only study reports that are considered final by the MAH(s) should be submitted to the Agency. 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. ”. However, some MAH/Applicant can choose not to request one. This guidance document addresses a number of questions which marketing authorisation holders (MAHs) may have on post-authorisation procedures. For joint studies, the contact point of the marketing authorisation holders or consortium may be contacted for financial purposes. EMA will send the package to the CMDh and prepare the translations for publication. variation, suspension or revocation of the marketing authorisation, the PRAC recommendation will be transmitted to the CHMP if it includes at least one CAP or to the CMDh if it includes only NAPs. Guideline of good pharmacovigilance practices (GVP) Module VIII - Post-authorisation safety studies. 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. New or revised Q&As are labelled 'New' or 'Rev' respectively together with the relevant date. full. Information regarding the discussion meeting is provided in the FAQ 21 “ How do I prepare for a Discussion meeting? Further guidance on PASSs is available in: The Agency publishes the protocols, abstracts and final study reports of PASSs in the EU post-authorisation study (PAS) register hosted on the European Network of Centres in Pharmacoepidemiology and Pharmacovigilance (ENCePP) website. If the above does not apply, the updated RMP should be submitted as a stand-alone variation. All centralised procedure submissions should be made via EMA eSubmission Gateway/Web Client only. The assessment under a 107n procedure is as follows, regardless whether it refers to one or more centrally authorised medicinal products, a mix of centrally authorised medicinal products and nationally authorised products, or nationally authorised products only. The timetable for the submission and assessment of imposed non-interventional PASS protocols is available below: The Agency recommends that companies submit protocols and study reports in the same manner for voluntary PASSs, although this is not mandatory. A Letter of Intent should be sent by email to scientificadvice@ema.europa.eu in advance of the anticipated start of the procedure. The outcome is a legally binding PRAC letter to the MAH(s) with the following options: In the instances when PRAC adopts a letter of objection, submission of an amended protocol will be required usually within 60 days (which could be shortened or extended depending on the revisions). Is a pre-submission meeting always expected or can the MAH/Applicant choose not to have one? Article 107p. A letter of intent for scientific advice should be submitted to the Agency at the mailbox scientificadvice@ema.europa.eu together with a briefing document in accordance with published EMA scientific advice guidance and timelines. It provides an overview of the European Medicines Agency’s position on issues that are typically addressed in discussions or meetings with MAHs in the post-authorisation phase. For centrally authorised products, if you cannot find the answer to your question in this Q&A when preparing your application, please contact the Risk Management Specialist (RMS) assigned to your product. European Medicines Agency - EMA organises a second public meeting about the new COVID-19 vaccines. European Medicines Agency post-authorisation procedural advice for users of the centralised procedure . Implementing variation needed, type and classification, Not applicable;implemented through EC decision to MAH, - IAIN C.1.3.a (harmonised national translations available), - IB C.1.3.z (adaptation of wording needed), - II (new data submitted; classification dependent on proposed changes), MAHs to submit variations within two months after receipt of the EMA communication encompassing the safety updates referred to in the relevant procedure. Will fees be levied for scientific advice provided for PASS protocols? note for guidance on the electronic data int erchange (edi) of individual case safety reports (icsrs) 1 and medicinal product reports (mprs) in pharmacovigilance during the pre-and post-authorisation phase in the european economic area (eea) discussion at the eudravigilance telematics implementation group (tig) may 2001, june 2001, march 2002, The experience from the pilot phase showed an added value of pre-submission meetings and therefore it is proposed that all procedures would have such meetings to discuss the briefing document. 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. When those are requested to be submitted, appropriate procedures should be followed (i.e. The procedure will commence at the next available start date after all validation issues have been resolved. However, Applicants should duly consider the best timing for their request for scientific advice, i.e. Changes in the milestones affecting the timelines for the submission of the final study reports should be considered as substantial amendments to the protocol and should consequently be submitted for assessment to the PRAC as an Article 107o procedure. 2. question & answers as published in the post-authorisation guidance for access to the hyperlinked . The guidance is based on Commission Implementing Regulation No 520/2012 of 19 June 2012. The Agency encourages scientific advice on safety studies to further develop an integrated lifecycle approach in the advice on medicines across safety, quality, efficacy pre- and post-authorisation, and to support proactive pharmacovigilance planning, which is elaborated through the Scientific Advice Working Party (SAWP) with the Pharmacovigilance Risk Assessment Committee (PRAC) endorsing the scientific advice letters in the case of PASS protocols. scientific advice procedure 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). Revised topics are marked ‘New’ or ‘Rev.’ upon … Where the proposed changes are not based on the data submitted within the final study report, these will not be considered and a variation will have to be submitted as appropriate to the relevant national competent authority. Employers may not ask about wage or salary history until after an offer of employment with compensation has been made. the sections [to be completed on a national level] simply to be translated as 'to be completed on a national level'. The Agency will inform the MAH of the outcome of the validation, the procedure number and procedural Figure 1: Overview of scientific advice procedure on PASS. MAHs have to follow the guidance since January 2013. Interim results and/or feasibility studies of non-interventional imposed PASS do not fall under the provisions in Articles 107n-q of Directive 2001/83/EC. Scientific advice on safety studies is a voluntary procedure for Marketing Authorisation Holders (MAH) or Applicants, and complementary to existing ones. Post-authorisation obligations, including specific obligations, Annex II conditions, additional pharmacovigilance activities in the RMP (MEA), legally binding … The European Medicines Agency (EMA) has released guidance on methods to be used in the design and conduct of post authorisation efficacy studies. 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. If the site still contains content that does not yet reflect the withdrawal of the UK from the EU, this is unintentional and will be addressed. Depending on the type of outcome and whether a EC Decision is required (CHMP opinion or CMDh position by majority), the timelines for the translation process vary depending on the need for a linguistic review as illustrated below: Translations of the adopted Annexes in EN and in all other EU languages (and in Icelandic and Norwegian) are to be provided electronically (in one Eudralink package if applicable) to the ” for each language if all comments have been implemented or not. 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? 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