Drug database
What are Czech requirements for reporting serious adverse reactions and non-serious adverse reactions to MP?
On 22nd November 2017 new extended EudraVigilance database was put into operation. As of this date, reports by all EV stakeholders have to be submitted to the EV database directly (centralized reporting system) within time limits stipulated by the law:
| From the date the expanded EudraVigilance database is put into operation | |
| All EU serious reports | Report to the EV database within 15 days |
| All EU non-serious reports | Report to the EV database within 90 days |
| Non EU serious reports |
Report to the EV database within 15 days |