Determining the appropriate subscription type
for your organization is based on the intended use of MedDRA,
the type of organization, as well as total annual revenues for
the organization. In order to determine what type of MedDRA
subscription you need, the following questions may be useful:
- Are you developing a software product that will utilize
MedDRA? If yes, please see the description for a System Developer
license.
- Are you a for-profit organization/company classifying, analyzing, or communicating data? If yes,
the organization does not qualify for a System Developer or Basic subscription. See eligibility for Core subscriptions.
- Are you a not for profit medical library, educational
institution, or direct patient care provider, i.e., hospital for
educational use or as a reference tool? If yes, true not for profit
organizations in these cases qualify for a Basic subscription.
- Are you a direct Government agency? Government agencies may subscribe at a Basic level if they are using MedDRA in support of a non-commercial endeavor, with no industry sponsor, that is not part of the development program for a marketing authorization of a medicinal product, or if potentially leading to a marketing application, where the holder of the intellectual property/patent is a not-for-profit organization. If your agency will be using MedDRA in a development program for a marketing authorization which will be the property/patent of a commercial entity/sponsor, you must subscribe at a Core 1 level.
- Are you a small or micro organization headquartered in the EU and sponsoring non-commercial clinical trials conducted in the EEA? If yes, you may qualify for a special Low Revenue MedDRA Fee Waiver license that is obtained through the EMEA. Please contact eudravigilance@emea.eu.int for eligibility, or read more on the Regulatory section of this web site.
After making a determination of which MedDRA subscription you qualify for, please review the rates to see which rate is applicable and fill it in on the Subscription Agreement.
If you are still unsure of your type of subscription type or level, we can help! Please fax (703.272.5635 USA) or mail the Subscription Agreement, leaving the “Subscription Level” section blank and we will contact you.
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