Pharmacovigilance

What is Pharmacovigilance?

• Definitions
• How we Monitor the Safety of Medicinal Products
• Medicinal Product Safety (brochure)

New Safety Information

This page contains news concerning activities in the area of pharmacovigilance.

Risk minimisation measures (RMM)

This page contains an overview of medicinal products with Risk Minimisation Measures (RMM) granted by HALMED. RMMs are additional measures introduced for certain medicines, the application of which is associated with specific risks - therefore they cannot be authorised without such measures.

Information for Marketing Authorisation Holders

• PSUR and PSUSA procedures
• Adverse Drug Reactions in Summaries of Product Characteristics and Patient Information Leaflets
• Instructions for Submitting Applications for Scientific Advice
• Risk Management Plan
• Inclusion of information as regard the medicinal product status under additional monitoring

Pandemic Influenza A/H1N1

• Recommendations for Use of Antiviral Medicines
• Recommendations for Use of Antiviral Medicines in the Treatment and Prevention of Influenza in Pregnant Women

Seal for Marking of Important Safety Information

In case of sending Dear Healthcare Professional Letters containing important safety information, which are prepared in collaboration with HALMED, marketing authorisation holders should place a seal prepared by HALMED on the front side of an envelope. Its purpose is to additionally emphasize the importance of information in the envelope.

Medicinal Products under Additional Monitoring

• Information related to medicines under additional monitoring
• List of medicinal products under additional monitoring

Submission of Application Documentation for Assessment of Non-Interventional Trials

Access to Databases of Suspected ADRs

• EMA's European Database of Suspected ADR Reports
• VigiAccess - Global Database for Suspected ADRs

How to Report an Adverse Drug Reaction

• Procedure
• On-line Reporting of ADRs
• Forms

Direct Healthcare Professional Communication

This page contains the chronological overview of Direct Healthcare Professional Communications, which contain information concerning safe use of medicinal products.

List of serious adverse reactions

On this page you can access the list of adverse reactions considered to be serious, but are not unambiguously determined according to the seriousness criteria stipulated in Guideline on Good Pharmacovigilance Practices (GVP) Module VI, as well as inclusion and exclusion criteria for this list.

Adverse Drug Reactions Reports

On this page you will find a chronological overview of Annual Reports on Spontaneous Reporting of Adverse Drug Reactions in Croatia, published regularly by HALMED.

Information for Marketing Authorisation Holders - Electronic Transmission of ICSRs

Page contains information related to Marketing Authorisation Holders' ADR reporting obligation.

Pharmacovigilance and Risk Assessment Committee (PRAC) - Links

• Basic Information on the PRAC
• Overview of the New Pharmacovigilance Legislation

Signal management

A safety signal is information on a new or known adverse event that is potentially caused by a medicinal product and that warrants further investigation.

SCOPE Project

On this page you will find information on participation of HALMED in the project of European Commission "Joint Action on Strengthening Collaboration for Operating Pharmacovigilance in Europe (SCOPE)".