Introduction

This guideline replaces PHV-3 guideline version 3 effective from 11. 01. 2016

The guideline provides a detailed description of terms, governs the conditions for performing the studies, provision of information and documents to the State Institute for Drug Control (SÚKL) in the area of non-interventional post-authorisation safety studies (PASS) of medicinal products for human use that are conducted in the Czech Republic and are initiated, managed or financed by a marketing authorisation holder voluntarily or pursuant to obligations imposed under Art.31a or 32a of Act No. 378/2007 Coll., on Pharmaceuticals, as amended (hereinafter referred to as “AoP”) or under Art. 21a or 22a of Directive 2001/83/EC (hereinafter referred to as “Dir.”).

The rights and obligations imposed on the marketing authorisation holder by the Act on Pharmaceuticals shall not be affected by this guideline.

This guideline should help distinguish non-interventional PASS from clinical trials, other types of studies and marketing activities of marketing authorisation holders. It also lays down a procedure for notifying the SÚKL about non-interventional PASS to strengthen and increase the efficiency of pharmacovigilance practices.

Non-interventional PASS are one of the tools of active pharmacovigilance for obtaining valid data and conducting of reasonable PASS presents a significant benefit for the evaluation of the safety profile of medicinal products under the conditions of common practice.

Types of non-interventional safety studies:

A non-interventional PASS can be performed:

a) Voluntarily by the marketing authorisation holder,

b) Based on an obligation imposed by a regulatory authority (SÚKL, EMA, other national authorities of the Member States) as a part of the initial marketing authorisation application (AoP Art.31a, Dir. Art.21a),

c) Based on an obligation imposed by a regulatory authority (SÚKL, EMA, other NAs) due to an emerging safety concern – during a post-authorisation phase (AoP Article 32a, Dir. Art.22a).

Related Regulations:

• Act No. 378/2007 Coll., on Pharmaceuticals as amended (hereinafter referred to as the “AoP”)
• Decree No. 228/2008 Coll., on Registration of Medicinal Products, as amended (hereinafter referred to as the “Decree”)
• Directive 2001/83/EC (as amended by Directive 2010/84/EU)
• Guideline on Good pharmacovigilance practices (GVP) – Module VIII – Post-authorisation safety studies
• Commission Implementing Regulation No. 520/2012

Affected clauses of AoP:

§ 93j, 93k of the Act

§ 3a of the Act

§ 17a of the Decree

Abbreviations:

Non-interventional PASS	Non-interventional post-authorisation safety studies
GVP	Guideline on Good vigilance practices
EMA	European Medicines Agency
PRAC	Pharmacovigilance Risk Assessment Committee
SmPC	Summary of Product Characteristics
RMP	Risk Management Plan for a medicinal product
PSUR	Periodic Safety Update Report
NA	National Authority
EU PAS	European Register of Post-Authorisation Studies
ENCePP	European Network of Centres for Pharmacoepidemiology and Pharmacovigilance
AoP	Act No. 378/2007 Coll., on Pharmaceuticals as amended