PHV-6 version 3
SÚKL requirements for reporting changes in the PSMF, for appointing the qualified person for pharmacovigilance and for appointing the contact person for pharmacovigilance issues in the Czech Republic
PHV-6_version3.pdf, file type pdf, (159.15 kB)
This guideline replaces PHV-6 version 2 with the effect from 08-Apr-2022.
This Guideline further defines the terminology and lays down the conditions which govern the provision of information and documents to the State Institute for Drug Control (hereinafter referred to as SÚKL) in the domain of the Pharmacovigilance System Master File. The Guideline also sets requirements regarding appointment of the qualified person responsible for pharmacovigilance of the marketing authorisation holder for a medicinal product, as well as an obligation to appoint the contact person for pharmacovigilance issues in the Czech Republic.
The Guideline is being issued on the basis of and in accordance with the provision of Sections 91 and 91a of Act No 378/2007 Coll., on Pharmaceuticals and on Amendments to Some Related Acts, and Guideline on Good Pharmacovigilance Practices (GVP), Module I, II.
The Guideline is legally binding.
Amendments in this version:
- Obligation to appoint the contact person for pharmacovigilance issues is valid for all marketing authorization holders.
- Unification of the deadlines for reporting the changes required by this guideline and clarification of the method of notifying the changes.