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MedDRA Subscription TypesYou can gain access to the MedDRA terminology by obtaining an annual, renewable subscription. Each subscription also brings you all MedDRA updates that incorporate approved changes and additions. To find your type of subscription, please go to determining the type of subscription. If you are a current MedDRA subscriber and need to renew your subscription, click the Renewal tab below. If you are a small organization headquartered in the EU and sponsoring non-commercial clinical trials conducted in the EEA, you may be eligible for access to MedDRA that is obtained through the European Medicines Agency (EMA). This access is not obtained through the MSSO. For more information click the Special License tab.
Basic Subscriptions are reserved for nonprofit medical libraries, educational institutions, and direct patient care providers, i.e., hospitals for educational use or as a reference tool. Provides subscribers with a copy of the MedDRA terminology via internet file download in English and all EU languages, as well as updates to the terminology with each release. Can be upgraded to a Core services subscription at any time. Basic subscribers also receive the following services and benefits: Help Desk Support
User Group Membership
Core Subscriptions provide access to the terminology in Czech, Dutch, English, French, German, Italian, Portuguese, and Spanish plus scheduled updates, via internet file download. Core services subscribers also enjoy a number of additional services and benefits:
Other Core MedDRA Services Documentation
Help Desk Support
User Group Membership
System Developer Subscriptions are reserved for organizations that develop software products that utilize MedDRA. The use of MedDRA by system developers will be for testing the terminology with their developed products and not for classification, analysis, or communication of data. Provides subscribers with a copy of the MedDRA terminology via internet file download in Czech, Dutch, English, French, German, Italian, Portuguese, and Spanish, as well as updates to the terminology each release. System developer subscribers also receive the following services and benefits: Help Desk Support
User Group Membership
All regulatory authorities are eligible to receive MedDRA at no charge. This includes the English version of each release of MedDRA as well as all available translations. All of the services listed under the Core subscription also apply to regulatory authorities. As with other types of subscriptions, we request that each regulatory authority complete the subscription agreement and provide the necessary contact information.
The MSSO notifies subscribers 30-45 days prior to their subscription expiration date. If your organization has not been contacted by the MSSO regarding your subscription renewal, please email our help desk at mssohelp@ngc.com and request a renewal invoice. To avoid a lapse in coverage, subscribers must arrange for payment of their MedDRA subscription renewal to be received by the MSSO no later than their current subscription end date. Subscribers should also ensure that all information on file is accurate, including subscription points of contact, billing points of contact, address and other organization information (i.e. changes in name). If you are unaware of the subscription account information that the MSSO currently has on file or need additional assistance, please email us at mssohelp@ngc.com. Special License MedDRA Subscription The EudraVigilance Fee Waiver MedDRA subscription is available to organizations that are going to use EVWEB for the reporting of ICSRs and/or SUSARs to National Competent Authorities in the EEA and the EMEA. The following organizations qualify for a EudraVigilance Fee Waiver MedDRA subscription:
The EudraVigilance Fee Waiver MedDRA subscription is obtained directly through the EMEA and not through the MedDRA MSSO. Please see the contact information at the bottom of this page. Definition of 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 aforementioned criteria are met, the subscription fee for the use of MedDRA via EVWEB is waived for Small and Micro Size Enterprise. The EudraVigilance Fee Waiver MedDRA subscription provides full access to MedDRA for coding and query purposes of ICSRs via EVWEB. MedDRA is not downloadable.
*Turnover or Balance sheet total refers to the total revenue of the company, not just the pharmaceutical component. Definition of a Sponsor of non-commercial clinical trials 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
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. If you have additional questions or need to contact an EMEA representative, please use the following Points of Contact: Abbreviations EEA – European Economic Area EMEA – European Medicines Agency – overall European regulator for drugs EudraVigilance/EVWEB – Web-based system developed by EMEA to collect and store ICSRs for all drugs with adverse events in Europe. They also forward ICSRs (and/or SUSARs) to individual National Competent Authorities if the event happened in their country. ICSR – Individual Case Safety Report – a report of an adverse event in a clinical trial or a marketed product MAH – Marketing Authorisation Holder – this is achieved by a company after they have received approval to market a drug in one or more European countries. National Competent Authorities – Regulatory agencies within each country (e.g., BfArM in Germany, MHRA in UK) SUSARs – Suspected unexpected serious adverse reactions
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mssohelp@ngc.com |
MedDRA MSSO |