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MedDRA Licensing Policy The EudraVigilance MedDRA licensing policy has been updated to align with the definition of Small and Micro Enterprises provided in Commission Recommendation 2003/361/EC:
The agreement reached at the MedDRA Management Board meeting in November 2004 to grant a fee waiver for non-commercial sponsors of clinical trials conducted in the EEA, has been reflected in the revised EudraVigilance MedDRA licensing policy as outlined in this document.
Background In accordance with the EU legislation1, in particular Regulation (EC) No. 726/2004 and Directive 2001/83/EC the electronic reporting of suspected serious adverse reactions by marketing authorisation holders (MAHs) to the European Medicines Agency (EMA) and national Competent Authorities (NCAs) in the European Economic Area (EEA) is mandatory from 20th November 2005. The reports related to these adverse reactions are referred to as Individual Case Safety Reports (ICSRs) in accordance with the ICH E2B (R2)2 guideline. In addition, in accordance with Directive 2001/20/EC and the implementing texts1, Sponsors of clinical trials (Sponsors) conducted in the EEA should report suspected unexpected serious adverse reactions (SUSARs) electronically. This requirement is applicable for all clinical trials that started in the EEA from 1st May 2004. In accordance with EU legislation and guidelines, both MAHs and Sponsors should use MedDRA, the medical terminology accepted at international level, for the coding of medical information and the electronic transmission of adverse reaction reports. 1For details about the reporting requirements, refer to the EU legislation published at the website of the Directorate General for Health and Consumers. 2The ICH E2B (R2) guideline ‘Maintenance of the ICH guideline on clinical safety data management: data elements for transmission of Individual Case Safety Reports E2B (R2). Recommended for Adoption at Step 4 of the ICH Process on 17 July 1997 and amended for Maintenance on 10 November 2000 by the ICH Steering Committee (Including the Post Step 4 corrections agreed by the Steering Committee on 5 February 2001) CPMP/ICH/287/95 modification corr.’ as published at: http://www.ich.org
EudraVigilance modules and EVWEB To address the electronic data collection process in the frame of the pharmacovigilance activities in the EEA, the EMA and the European Commission set up the following two EudraVigilance modules:
Furthermore, the EMA provides to interested organisations with reporting obligations in pharmacovigilance (pre- and post-authorisation phase) the possibility to use EVWEB, a web-based application, which is an integrated part of the European pharmacovigilance system called EudraVigilance. EVWEB also incorporates MedDRA in the latest version and allows for electronic reporting to the EMA and the NCAs in the EEA in compliance with the applicable ICH standards.
EudraVigilance MedDRA Licensing Policy The MedDRA Maintenance and Support Service organisation (MSSO) and the Japanese Maintenance organisation (JMO), based on the policy adopted at the level of the MedDRA Management Board, support the practical implementation of MedDRA in the EEA. The European Commission, the EMA and the European Federation of Pharmaceutical Industry Associations (EFPIA), elaborated in collaboration with the MedDRA MSSO and the JMO a proposal on the basis of a cost-effective access to MedDRA. As a general principle, access to the MedDRA terminology can be gained by obtaining an annual renewable subscription. To support the use of MedDRA within the EEA, whilst taking into account the fact that the EMA developed EVWEB to facilitate the electronic reporting of ICSRs and SUSARs in line with Community legislation, two levels of MedDRA subscriptions are available to pharmacovigilance stakeholders:
Full MedDRA Subscription The terms and conditions related to a full MedDRA subscription are published at the MedDRA MSSO website at http://www.meddramsso.com. There are three levels of subscriptions available:
Each subscription brings all MedDRA updates that incorporate approved changes or additions. Organisations that qualify for a full MedDRA subscription specify during the registration process3 with EudraVigilance their MedDRA license number. These organisations will be able to access EudraVigilance including MedDRA in accordance with the official access policies adopted at Community level. Regulators have also to subscribe for MedDRA but are exempt from
a MedDRA license fee.
Use of MedDRA by small and micro enterprises and non-commercial sponsor organisations There are low revenue pharmaceutical companies i.e. small and micro size enterprises for which the cost of a MedDRA subscription, even at the lowest level, may be cost prohibitive. It is often the case that these companies also transmit very few adverse reaction reports to regulators. The same concerns apply to Sponsors of non-commercial clinical trials, for whom the costs of a MedDRA license could endanger the ability of conducting clinical trials in the EEA. Given the EU requirements for electronic reporting in pharmacovigilance based on the standards adopted at the level of ICH, which involve reporting of ICSRs and SUSARs using MedDRA, the MedDRA Management Board approved a special EudraVigilance licensing policy, which is outlined below.
EudraVigilance Fee Waiver MedDRA Subscription The EudraVigilance Fee Waiver MedDRA subscription is available to organisations intending to use EVWEB for the reporting of ICSRs and or SUSARs to NCAs in the EEA and the EMA. The following organisations qualify for a EudraVigilance Fee Waiver MedDRA subscription:
The definitions for these organisations are provided below in Definition of small and micro enterprises and Definition of a Sponsor of non-commercial clinical trials. Small and Micro Size Enterprises Small and Micro Size Enterprises must meet the following criteria to qualify for a EudraVigilance Fee Waiver MedDRA subscription:
If the above criteria are met, the subscription fee for the use of MedDRA via EVWEB is waived. Definition of small and micro enterprises While the EMA SME office registers and offers support to micro, small or medium-sized enterprises, only organisations meeting the criteria of micro or small are eligible for the EudraVigilance Fee Waiver MedDRA Subscription. The following criteria define micro or small organisations:
Sponsors of non-commercial clinical trials should inform the EudraVigilance registration department at the time of registration. Sponsors of non-commercial clinical trials With regard to Sponsors of non-commercial clinical trials conducted in the EEA, the subscription fee for the use of MedDRA via EVWEB is waived.
Definition of a Sponsor of non-commercial clinical trials A sponsor of a non-commercial clinical trial is a sponsor that is only sponsoring non-commercial clinical trials, as defined below. In accordance with Directive 2001/20/EC, a non-commercial clinical trial is defined as a trial:
A trial does not disqualify from being classified as non-commercial:
General aspects MedDRA Subscribers in Japan Fully owned subsidiaries of pharmaceutical companies, classify for the ‘Full MedDRA Subscription’ as described in chapter 5.1 if the company headquarter is located in Japan and is a JMO subscriber. Quarterly reports of the EMA to the MedDRA MSSO and JMO In accordance with the licensing policy as described in this document, the EMA is requested to provide the MedDRA MSSO and JMO with a quarterly report of the organisations, which have registered with EudraVigilance for electronic reporting purposes of ICSRs/SUSARs. The report includes the organisation's name, point of contact, email address, phone number and mailing address including the category of EudraVigilance MedDRA License Subscription. The MedDRA MSSO will review this report to ensure that they are satisfied that all organisations benefiting from a EudraVigilance Fee Waiver MedDRA Subscription are eligible. MedDRA Management Board and the EudraVigilance Licensing Policy The EudraVigilance Licensing Policy can only be extended by mutual agreement of both the EMA and the MedDRA Management Board. The policy is regularly reviewed at the MedDRA Management Board level.
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