Introduction

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:

• Cancellation of the obligation to report a change in the position of the Deputy QPPV (Paragraph 2. Changes to the Pharmacovigilance System Master File which need to be reported to SÚKL).
• Addition of the obligation to report a change in the name of the marketing authorization holder (Paragraph 2. Changes to the Pharmacovigilance System Master File which need to be reported to SÚKL).
• Detailed specification for reporting changes of the pharmacovigilance database
• Addition of a reference to the Act on Pharmaceuticals (Paragraph 3. Requirements for the qualified person for pharmacovigilance and reporting of appointment/change of the QPPV to SÚKL). At the same time, it is emphasized that the obligation applies to all marketing authorisation holders.
• Emphasis on the obligation to report a pharmacovigilance contact person for all marketing authorisation holders (Paragraph 4. Appointment/change of the contact person for pharmacovigilance issues in the Czech Republic). – Change of e-mail address for notification of changes
• Specification of contact details that shall be reported for QPPV (Paragraphs 2. and 3).
• Removal of the transitional provision.

Resources, including the legislative basis of the Guideline

Act No. 378/2007 Coll., on Pharmaceuticals and on Amendments to Some Related Acts (the Act on Pharmaceuticals), as amended, (hereinafter the “Act on Pharmaceuticals”)

Guideline on good pharmacovigilance practices (GVP), Module I, II

Abbreviations