Pharmacovigilance

Procedure

All adverse reactions to medicinal products must be reported in writing to the Agency for Medicinal Products and Medical Devices, and, in the case of vaccines, also to the Croatian Institute for Public Health, according to the procedure set out in the Medicinal Products Act (Official Gazette, No. 76/13) and the Ordinance on Pharmacovigilance (Official Gazette, No. 83/13).

Adverse reactions as well as suspected adverse reactions are required to be reported by

  • Healthcare professionals coming in contact with the user of the medicinal product
  • Manufacturers of medicinal products
  • Marketing authorisation holders of medicinal products
  • Healthcare professionals acting as investigators in clinical trials, which are required to immediately report serious adverse reactions to the clinical trial sponsor

The healthcare professional should report an adverse reaction/suspected adverse reaction to a medicinal product via the Adverse reaction reporting form for healthcare professionals (in Croatian): (.doc) (.pdf)

The completed form should be sent via courier (or submitted in person) to the following address:

Agency for Medicinal Products and Medical Devices
Ksaverska cesta 4
HR-10000 Zagreb

Via fax: +385 1 4884 110
Or e-mail: nuspojave@halmed.hr

More detailed instructions for reporting adverse reactions/suspected adverse reactions may be found in the: Adverse reaction reporting form for healthcare professionals

Urgent reporting of adverse reactions/quality defects

Should you need to report adverse reactions/suspected adverse reactions urgently and outside opening hours of the Agency, listed below are the telephone numbers which can be used for this purpose.

Phone: +385 800 48 00 08 (free of charge, 0 a.m. - 12 p.m., for rapid alerts that could lead to a recall)
Fax: +385 1 4884 120 (for rapid alerts that could lead to a recall)

Every adverse reaction/quality defect reported via phone should be subsequently reported in writing, via appropriate forms.

Adverse reactions to vaccines

In accordance with the Art. 145 of the Medicinal Products act (Official Gazette, No. 76/13), in the case of adverse reactions to vaccines, healthcare professionals, marketing authorisation holders and vaccine manufacturers are required to send a completed Form (in Croatian) (.doc) (.pdf) both to the Agency (same address as above) and to the Croatian Institute for Public Health, i.e. to the:

Croatian Institute for Public Health
Department for Epidemiology of Infectious Diseases

Rockefellerova 7
HR-10000 Zagreb
Fax: +385 1 46 83 877

The Reporting form (in Croatian) of the Croatian Institute for Public Health (HZJZ) can be accessed here http://hzjz.hr/wp-content/uploads/2013/11/nuspojava-prazna1.pdf

In the case of grouping of adverse reactions or adverse reactions with a lethal outcome, as well as unusual or severe adverse reactions, the incident should be immediately reported to the Croatian Institute for Public Health:

  • During opening hours on the phone number: +385 1 46 83 005
  • Out of office hours to the epidemiologist-on-duty on +385 98 22 77 53, and also to the Department of Epidemiology of the County concerned.

Adverse reaction reports from patients

The patient/user of the medicinal product should inform his/her doctor, pharmacist or other healthcare professional about every suspected adverse reaction to a medicinal product and vaccine.

The patient/user of the medicinal product may also directly report all suspected adverse reactions in writing to the Agency, via the On-line application for ADRs reporting, or the Form (in Croatian) (.doc) (.pdf), or to the marketing authorisation holder. The adverse reaction may be reported by the user of the medicinal product, or by a parent, legal representative or caregiver of a person with disability, severe psychiatric disorder or a minor.

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