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FAQs: EudraVigilance’s EVWEB and MedDRA
1) What is the relationship between MedDRA and EudraVigilance? MedDRA is the international medical terminology (Medical Dictionary for Regulatory Activities) developed under the auspices of ICH. As the terminology requires to be constantly updated, a Maintenance and Support Service Organisation (MSSO) was appointed under the umbrella of ICH to maintain and distribute the terminology, on license, to users in industry and regulatory agencies. In Japan, the MedDRA maintenance is taken care of by the Japanese Maintenance organisation (JMO). The activities of the MedDRA MSSO are overseen by the MedDRA Management Board composed of the 6 ICH parties, the Medicines and Healthcare products Regulatory Agency (MHRA) of the UK, Health Canada, and The World Health organisation and chaired by the IFPMA (International Federation of Pharmaceutical Manufacturers & Associations). In accordance with EU legislation and guidelines, MedDRA should be used by all stakeholders for the coding of medical information in the frame of the electronic transmission of individual case safety reports (ICSRs). The EMA provides interested organisations with reporting obligations in pharmacovigilance (pre- and post-authorisation phase) the possibility to use EVWEB, a web-based application, which is an integrated part of the European pharmacovigilance system called EudraVigilance. EVWEB incorporates MedDRA and allows for electronic reporting of ICSRs to the EMA and National Competent Authorities in the EEA in compliance with the applicable ICH standards. The MedDRA Management Board approved a MedDRA licence fee waiver programme to facilitate the electronic reporting by small and micro organisations and non-commercial sponsors of clinical trials. For details about the MedDRA licence fee waiver click here EVWEB includes the use of MedDRA for reporting ICSRs and SUSARs into the EudraVigilance system. The access to MedDRA thought the EVWEB is for use online and cannot be downloaded. EVWEB does not allow for off-line use of MedDRA for creating reports or analysis.
2) Who do I have to contact to get my MedDRA licence? The MSSO. To initiate a MedDRA Subscription, please visit the Subscribe to MedDRA section of the MedDRA MSSO web site. The site provides rates, subscription levels, applications, and information on how to subscribe to MedDRA. If you require further information, please contact mssohelp@ngc.com.
3) What is my MedDRA license number? The MedDRA MSSO assigns a number to each organisation that applies for a MedDRA licence. An organisation’s MedDRA license number is a unique number you are given when you subscribe to MedDRA from the MSSO or the JMO. It is equivalent to the MedDRA User ID number associated with that organisation’s MedDRA subscription. Organisations that qualify for the MedDRA licence fee waver in the frame of EudraVigilance don’t require a MedDRA licence number.
4) How do I determine if I qualify for a MedDRA licence fee waiver? Please see the MedDRA Licensing Policy page for a description of the eligibility criteria
5) How do I apply for a MedDRA licence fee waiver? To confirm your eligibility, your organisation will need to register with the SME office. If your organisation qualifies, you do not need to specifically apply for a fee waiver. While registering with EudraVigilance follow the instructions. For more information Click Here If you require further help, please contact the EMA as follows:
6) We are a CRO reporting to EudraVigilance on behalf of multiple pharma companies; do both parties have to have a MedDRA license in order to use the EVWEB? The companies that you are representing need to be registered with EudraVigilance. As part of the registration process they will state that you are their third party service provider, and register your details. As part of the registration process every registering organisation will be asked to provide MedDRA subscription information:
The organisation for which you are acting as third party service provider has to obtain a MedDRA licence number and provide that number during the registration process with EudraVigilance. Please note that the MedDRA licence number required in the registration form with EudraVigilance is the registering organisation’s own, not the MedDRA's licence number (see question 3) of any third party provider, such as a CRO.
7) Do I first need a MedDRA licence fee waiver to qualify to use the EVWEB system? If your organisation qualifies for the MedDRA licence fee waiver for EudraVigilance, you don’t need a MedDRA subscription to use the EVWEB. If your organisation does not qualify for the MedDRA licence fee waiver, yes, you need to purchase a MedDRA subscription in order to utilize the EVWEB system (see question 4).
8) Registering with EudraVigilance versus obtaining a MedDRA licence All organisations with electronic reporting responsibilities to the EMA need to register with EudraVigilance Click Here During the registration procedure with EudraVigilance you will be asked to declare your MedDRA licence subscription status:
9)What is the versioning policy for reporting ICH ICSRs? With regards to the reporting of ICSRs to the EMA, the followings MedDRA versions are accepted:
Please note that MedDRA versions are updated every 6 months (March and September). The MSSO does recommend organisations to follow the Best Practices document published on the MSSO web site at http://www.meddramsso.com/files_acrobat/clinicaltrialversioning.pdf, which is endorsed by the MedDRA Management Board and provides options and recommendations for the implementation and versioning for clinical trials.
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