Each subscription brings all MedDRA updates that contain approved changes or additions. For sponsors of non-commercial clinical studies conducted in the EEA, subscription fees for the use of MedDRA via EVWEB are waived. In order to support the use of MedDRA in the EEA, while taking into account the development of EVWEB by the EMA in order to facilitate the electronic notification of ICSR and susars in accordance with Community legislation, pharmacovigilance stakeholders have two levels of MedDRA subscriptions: the agreement reached at the MedDRA Management Board meeting in November 2004, grant a royalty exemption to non-commercial sponsors of clinical trials conducted in the EEA; has been taken into account in the revised EudraVigilance MedDRA Licensing Directive, as described in this document. There are low-turnover pharmaceutical companies, namely: Small and micro enterprises for which the cost of a MedDRA subscription can be prohibitive even at the lowest level. Often, these companies transmit very few adverse reaction reports to regulatory authorities. The same concerns apply to sponsors of non-commercial clinical trials for which the cost of a MedDRA licence could compromise the ability to conduct clinical trials in the EEA. There is no restriction on the number of ICSRs that can be transferred by small and smaller companies that qualify for a subscription to EudraVigilance Fee Waiver MedDRA. The MedDRA subscription to eudraVigilance Fee Waiver is made available to organisations that intend to use EVWEB for the notification of ICS and/or SUSAR to the EEA and EMA NNAs. If the above criteria are met, the subscription fee for using MedDRA via EVWEB is waived. The EudraVigilance Fee Waiver MedDRA subscription provides full access to MedDRA for the purpose of coding and consulting ICSRs via EVWEB. Unable to download MedDRA. Small and micro enterprises must meet the following criteria to qualify for a MedDRA subscription to EudraVigilance Fee Waiver: organizations that qualify for a full subscription to MedDRA indicate their MedDRA license number during the registration process3 with EudraVigilance.
These organisations will be able to access EudraVigilance, including MedDRA, in accordance with official access policies adopted at community level. In principle, access to MedDRA terminology can be obtained through the acquisition of an annual renewable subscription. EudraVigilance`s licensing policy can only be renewed by mutual agreement between the EMA and the MedDRA Board of Directors. The policy is regularly reviewed at the level of MedDRA`s Board of Directors. Taking into account the EU`s pharmacovigilance electronic reporting requirements, based on the standards adopted at ICH level, regarding the notification of ICS and susaRs with MedDRA, the MedDRA Management Board has approved a specific licensing policy for EudraVigilance, described below. In addition, the EMA offers interested organisations with pharmacovigilance obligations (pre-authorisation and post-authorisation) to use EVWEB, a web-based application, which is an integral part of the European pharmacovigilance system called EudraVigilance. EVWEB also integrates MedDRA in the latest version and allows electronic reporting to the EMA and NCAs in the EEA, in accordance with current ICH standards. . . .