EudraVigilance Veterinary not available for 10 days starting 8 November 2017
The new EudraVigilance system for the reporting and analysis of suspected adverse reactions (ADRs) to medicinal products, will become operational on 22 November 2017. To allow the change-over to the new system, the current EudraVigilance Veterinary system will be unavailable from 8-21 November 2017. In case of any emerging serious pharmacovigilance issue that potentially would require urgent regulatory actions, the marketing authorisation holder must inform the Veterinary Medicinal Products Unit (VMPU).
EudraVigilance will become unavailable on 8 November 2017, 1.00 a.m. (Netherlands time) and will be operational again on 22 November 2017, 10.00 a.m. (Netherlands time). This is the downtime period. During this downtime period, key components of EudraVigilance will not be available. Any reporting submitted during the downtime period will be erased. Veterinarians and animal owners can report adverse events in the usual manner; marketing authorisation holders and the VMPU of the MEB Agency will take care of the processing.
Submitting Dutch reports during the downtime period
For submission of Dutch reports to EudraVigilance during the downtime period, the following will apply to marketing authorisation holders:
- During the downtime period it is not possible to submit reports of suspected ADRs.
- In case of any emerging serious pharmacovigilance issue that potentially would require urgent regulatory actions, the marketing authorisation holder must inform the VMPU of the MEB Agency via e-mail address email@example.com, and the European Medicines Agency (EMA) if relevant.
- Submissions to EudraVigilance will be possible from 22 November 2017 10:00 a.m. (Netherlands time).
- Reports requiring submission during the downtime period should still be submitted to EudraVigilance. The EMA provides more information on the timeframe for submitting these reports.
- During the downtime period reports from veterinarians and animal owners must be received as usual. These can be submitted to EudraVigilance from 22 November 2017.