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PHV-4 version 8

ELECTRONIC REPORTING OF ADVERSE DRUG REACTIONS

PHV-4_version8.pdf, file type pdf, (206.5 kB)

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