ELECTRONIC REPORTING OF ADVERSE DRUG REACTIONS
As of 1st September 2023, this Guideline shall supersede PHV-4 version 8.
The Guideline is issued on the basis and in accordance with the provision of Section 91 paragraph 4 and Section 93a of Act no. 378/2007 Coll., on Pharmaceuticals.
The Guideline concerns the reporting of suspected adverse reactions to medicinal products in their post-authorisation period, i.e. those sent to the EVPM module of the EudraVigilance database. The ADR reports from clinical trials (SUSARs) sent to the EVCTM module of the EudraVigilance database follow the relevant guidances of EMA and the Clinical Trials Department of SÚKL.
The Guideline is legally binding.
Amendments in this Guideline:
- Specify the group of ADR reports to which the Guideline applies
- Repeal information on the no longer valid R2 format for ADR reporting
- Modify the process for submitting literature articles
- Clarify the requirements for follow-up requests