ELECTRONIC REPORTING OF ADVERSE DRUG REACTIONS
As of 17th May 2019, this Guideline shall supersede PHV-4 version 6.
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 clarify:
- Submission of contact information to SÚKL of the person responsible for ICSR reporting
- Submission of literature articles to SÚKL