There are low-revenue pharmaceutical companies, i.e. small and smaller companies, for which the cost of a MedDRA subscription, even at the lowest level, can be prohibitive. These companies often also report very few reports of adverse events to regulators. These same concerns apply to proponents of non-commercial clinical trials for whom the cost of an MedDRA license could compromise the ability to conduct clinical trials in the EEA. Small and small businesses must meet the following criteria to qualify for a subscription to EudraVigilance Fee Waiver MedDRA: there is no limit to the number of ICSRs that can be transferred by small and small businesses eligible for an Eudravigilance Fee Waiver MedDRA subscription. The eudravigilance directive on licences can only be renewed by mutual agreement between the EMA and the MedDRA Board of Directors. Policies are regularly reviewed at the MedDRA board level. If the above criteria are met, the subscription fee for using MedDRA via EVWEB will be waived. The EudraVigilance Fee Waiver MedDRA subscription provides full access to MedDRA for coding and viewing ICSR via EVWEB. MedDRA cannot be downloaded. The EudraVigilance Fee Waiver MedDRA subscription is available for organizations wishing to use EVWEB to notify ICSRs and SUSARs to EEA and EMA NCAs.
The agreement reached at the MedDRA Board meeting in November 2004 to grant a royalty exemption to non-commercial proponents of clinical trials in the EEA is reflected in Eudravigilance MedDRA`s revised licensing policy, as outlined in this document. Each subscription contains all MedDRA updates that contain approved changes or additions. Organizations that qualify for a full MedDRA subscription give their MedDRA license number during the registration process with EudraVigilance3. These organisations will have access to EudraVigilance, including MedDRA, in accordance with official access policies adopted at the community level. In order to support the use of MedDRA within the EEA, the players in pharmacovigilance have two levels of MedDRA subscriptions: for sponsors of non-commercial clinical trials conducted in the EEA, subscription fees for the use of MedDRA through EVWEB are waived. In principle, access to MedDRA terminology can be acquired by acquiring a year. Regulators must also subscribe to MedDRA, but they are exempt from an MedDRA levy. 3How To Register While the EMA FOR SMEs registers and supports micro, small and medium-sized enterprises, only organizations that meet the criteria for micro or micro-countries are eligible to subscribe to the EudraVigilance Fee Waiver MedDRA subscription. The following criteria define micro-organizations or small organizations: the definitions of these organizations are presented below in the definition of micro-enterprises and micro-enterprises and the definition of a promoter of non-commercial clinical trials. . In accordance with EU1 legislation, including Regulation (EC) 726/2004 and Directive 2001/83/EC, Electronic notification of suspected serious adverse reactions by holders of marketing authorisations (MAHs) to the European Medicines Agency (EMA) and the relevant national authorities (ANC) in the European Economic Area (EEA) is mandatory from 20 November 2005. Reports of these adverse events are referred to as individual case safety reports (ICSRs) in accordance with Directive ICH E2B (R2) 2.
The Eudravigilance MedDRA licensing policy has been updated to take into account the definition of micro-enterprises and micro-enterprises in the Commission`s 2003/361/EC recommendation: A study does not prohibit the use of EMA`s quarterly reports to MedDRA MSSO and JMO The MedDRA Maintenance and Support Service Organisation (MSSO) and the Japan Maintenance Organization (JMO), based on MedDRA`s Board of Directors, support the practical implementation of MedDRA in the EEA.