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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 |
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:
- MAHs that are Small and Micro Size Enterprises
- Sponsors of non-commercial Clinical Trials conducted in the EEA
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:
- Comply with the definition of a Small and Micro Size Enterprise as defined
- The Small and Micro Size Enterprise must be located in the European Economic Area (EEA)
- The Small and Micro Size Enterprise uses EVWEB to report electronically to EMEA
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.
Enterprise category |
Turnover* |
Or |
Balance sheet total* |
Small |
= 10 millions Euros |
= 10 millions Euros |
Micro |
= 2 millions Euros |
= 2 millions Euros |
*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:
- Conducted by a non-commercial organization, 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.
A trial does not disqualify from being classified as non-commercial
- If the trial is funded in the form of an educational,
unrestricted grant for administrative support, providing the funds
do not exceed 10% of the cost of the trial, or
- Where drug is provided free by a company.
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:
EudraVigilance Info Line +44 (0) 207 523 7077
EudraVigilance e-mail: eudravigilance@emea.europa.eu
EudraVigilance:
http://eudravigilance.emea.europa.eu
To Register : http:eudravigilance.emea.europa.eu/human/HowToRegister
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