Pharmacovigilance

Procedure

All adverse reactions to medicinal products must be reported in written 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), and for medical devices according to the provisions set out in the Medical Devices Act (Official Gazette, No. 76/13), Ordinance on monitoring adverse incidents associated with medical devices (Official Gazette, No. 74/09).

The legal obligation to report an adverse reaction as well as a suspected adverse reaction have:

  • health care professionals coming in contact with the user of the medicine/medical device
  • the manufacturer of the medicinal product/medical device
  • the registration holder for medical devices
  • all legal and physical entities coming into contact with the user of medical device
  • the health care professional participating as investigator in the clinical trial, is required to report all serious adverse events (to the medicinal product) immediately to the sponsor of the clinical trial

The healthcare professional reports the adverse reaction/suspected adverse reaction to medicinal product and/or medical device via Application form for reporting adverse reaction for health care professional: (.doc) (.pdf)

The filled forms 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

Deatailed instructions for reporting adverse reactions/suspected adverse reactions may be found in: The application form for reporting adverse reaction for health care professional

Urgent reporting of adverse reactions/quality defects

For reporting adverse reactions/suspected adverse reactions, below you will find phone numbers at your disposal, that may be used exclusively in the case of an urgent reporting of adverse reactions and quality defects of medicinal products/medical devices, outside opening hours of the Agency.

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 a written form on the appropriate forms.

Adverse vaccine reactions

According to the Art. 145 of the Medicinal Products act (Official Gazette, No. 76/13), healthcare professionals, marketing authorisation holders or vaccine manufacturers are in the case of an adverse vaccine reaction/suspected adverse vaccine reaction required to send the filled application form (.doc) (.pdf) to both, the Agency for Medicinal Products and Medical Devices (to the above mentioned address) and the Croatian Institute for Public Health to the following address:

Croatian Institute for Public Health
Department for Epidemiology of Infectious Diseases
Rockefellerova 7
HR-10000 Zagreb
Fax: +385 1 46 83 877

The form of the Croatian Institute for Public Health (HZJZ) is accessible 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 vaccine reactions, the report should be immediately expedited to the Croatian Institute for Public Health:

  • during the opening hours on the phone number: +385 1 46 83 005
  • during 24 h to epidemiologist-on-duty on +385 98 22 77 53, and also to the Department of Epidemiology of the County concerned.

Adverse reactions reports from patients

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

The patient/user of the medicinal product may also directly in a written form report all suspected adverse reactions to medicinal products or vaccines marketed in Croatia to the agency via On-line application for ADRs reporting, or via Application form (.doc) (.pdf) or to the marketing authorisation holder. The adverse reaction may be reported by the user of the medicine, or on behalf of a disabled person, person with a severe psychiatric disorder or minor person his/her parent, legal representative or tutor.

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