PHV-4 version 7

ELECTRONIC REPORTING OF ADVERSE DRUG REACTIONS

PHV-4_version_7.pdf, soubor typu pdf, (207.95 kB)

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