ELECTRONIC REPORTING OF ADVERSE DRUG REACTIONS
As of 8th April 2022, this Guideline shall supersede PHV-4 version 7.
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 is legally binding.
Amendments in this Guideline:
- Repeal the obligation to submit to SÚKL the contact details of the person responsible for ICSR reporting
- Modification of information on local requirements for literature reports