Introduction and general provisions

As of 1st September 2023, this Guideline shall supersede PHV-4 version 8.

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 concerns the reporting of suspected adverse reactions to medicinal products in their postauthorisation period, i.e. those sent to the EVPM module of the EudraVigilance database. The ADR reports from clinical trials (SUSARs) sent to the EVCTM module of the EudraVigilance database follow the relevant guidances of EMA and the Clinical Trials Department of SÚKL.

The Guideline is legally binding.

Amendments in this Guideline:

• Specify the group of ADR reports to which the Guideline applies
• Repeal information on the no longer valid R2 format for ADR reporting
• Modify the process for submitting literature articles
• Clarify the requirements for follow-up requests

1.1 Purpose of the Guideline specification

The Guideline specifies the rules of electronic exchange of adverse reaction reports concerning medicines for human use via the EudraVigilance (EV) system. The Guideline is intended for marketing authorization holders and organizations that perform electronic reporting of adverse reaction reports in format E2B (R3) on behalf of marketing authorization holders. The content and general rules of reporting are governed by the applicable legal regulations and guidance of SÚKL and the Agency.

1.2 List of abbreviations

ACK	acknowledgement message sent by a report receiver to a report sender
ADR	adverse drug reaction
EEA	European Economic Area
EMA	European Medicines Agency, hereinafter also the “Agency”
EV	EudraVigilance
EVCTM	EudraVigilance Clinical Trial Module
EVPM	EudraVigilance Post-Authorisation Module
FU	follow-up report
GVP	Guideline on good pharmacovigilance practices
ICH	International Conference on Harmonization
ICSRs	Individual Case Safety Reports
ID	Identifier in the EudraVigilance system
ISO	International Organization for Standardization
MAH	Marketing Authorisation Holder
SÚKL	State Institute for Drug Control
SUSAR	Suspected unexpected serious adverse reaction

1.3 Legislative and standardisation base of the guideline

Act No. 378/2007 Coll., on Pharmaceuticals and on Amendments to Some Related Acts, as amended (hereinafter the “Pharmaceuticals Act” or the “Act”) Decree No. 228/2008 Coll., on the marketing authorisation of medicinal products, as amended

Regulation (EC) No. 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency

Guideline on good pharmacovigilance practices: Annex 1 – Definitions

Guideline on Good Pharmacovigilance Practices Module VI: Management and reporting of adverse reactions to medicinal products

Note for guidance – EudraVigilance Human – Processing of safety messages and individual case safety reports (ICSRs) including other EU guidelines and ICH standards (in particular E2B, M1 and M2).

Implementation Guide for Electronic Transmission of Individual Case Safety Reports (ICSRs): E2B(R3) Data Elements and Message Specification EU Individual Case Safety Report (ICSR)

Implementation Guide Announcement of the EMA Mangement Board – Confirmation of the mandatory use of the ISO Individual Case Report standard based on ICH E2B(R3) modalities and related ISO standard terminology, EMA/561671/2019 Mandatory use of ISO ICSR/ICH E2B(R3) and EDQM terminology for Dosage Forms (DF) and Routes of

Administration (RoA), EMA/580321/2021 Rev 1

SÚKL Guideline PHV-6 – 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

Further details can be found in the relevant ongoing Q&A documents published on the EMA website.