EudraVigilance is the centralized European database of suspected adverse reactions to medicines that are authorized or being studied in clinical trials in the European Economic Area (EEA). It is used by national competent authorities (NCAs), the European Medicines Agency (EMA), Marketing Authorization Holders (MAH) and sponsors of clinical trials.
EMA is responsible for the development, maintenance, and coordination of the EudraVigilance system.
Adverse reactions reporting by MAH holding or applying for a Marketing Authorization and sponsors of clinical trials in the EU/EEA is mandatory and is done electronically to the authorities through EudraVigilance.
The reporting of adverse reactions through the EudraVigilance system facilitates:
- the electronic exchange of individual case safety reports (ICSRs)
- early detection and evaluation of possible safety signals
- better product information for authorized medicines
Marketing Authorization Holders (MAH) of medicinal products are legally obliged to have permanently and continuously at their disposal an appropriately qualified person responsible for pharmacovigilance in the European Union (the EU QPPV).
The European Union QPPV is based in the EU or in the EEA and is responsible for the implementation and maintenance of the MAH's pharmacovigilance system which ensures that information about all suspected adverse reactions reported to the company is collected, processed, and reported to the competent authority of the Member State in which the incident occurred.
(see Directive 2001/83/EC).
Each pharmacovigilance system can have only one QPPV.
MAH must report to EudraVigilance:
- Suspected serious adverse reactions occurring within and outside the EEA
- Suspected non-serious adverse reactions occurring within the EEA
Sponsors of clinical trials must report to EudraVigilance:
- Suspected unexpected serious adverse reactions (SUSARs)
The reported information will then be assessed by the relevant EU/EEA authority.
In order to be able to report electronically in EudraVigilance, pharmaceutical companies and sponsors of clinical trials in the EEA need to register with EudraVigilance.
For MAH or applicants for a Marketing Authorization in the EEA, the QPPV of the organization’s headquarter in the EEA is the organization’s representative and should also be register with EudraVigilance.
Sponsors should nominate a responsible person (RP) for EudraVigilance and register her/him in Eudravigilance.
The QPPV in Eudravigilance:
- is responsible for the access and use of the EudraVigilance database system made by the authorized users within his/her organization.
Notes:
- ICSR: a document providing information related to an individual case of a suspected side effect due to a medicine.
- Suspected Unexpected Serious Adverse Reactions (SUSARs): Adverse reactions due to medicines administered in a clinical trial that are unexpected and serious.
Are you looking for a QPPV?
Discover AxeRegel EU QPPV and Local QPPV services here.
Email: contact@axeregel.com
Phone: +33 (0)1 72 69 01 81
Links/Sources:
- New Organization First User QPPV/RP or Change of EU QPPV/RP (updated, 07/12/2022)
- EudraVigilance user declaration for qualified person for pharmacovigilance/responsible person for EudraVigilance (updated, 14/12/2022)
- EMA: https://www.ema.europa.eu/en
- Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use
- EMA EudraVigilance Registration Manual
- EudraVigilance Registration Frequently Asked Questions
- Quick interactive guide to EudraVigilance (EV) registration process