How to Report a Suspected Adverse Reaction (ADR)
What is an adverse reaction?
Adverse reaction is every response to a medicinal product which is noxious and unintended. This includes adverse reactions arising from use of the product within or outside the terms of the marketing authorisation (including overdose, off-label use, misuse, abuse and medication errors) and adverse reactions arising from occupational exposure.
Why report an adverse reaction?
HALMED is a governmental agency for medicinal products and medical devices that aims to protect public health by providing to the population of the Republic of Croatia safe, effective and good quality medicines and medical devices. In order to ensure safe medicines for the population, HALMED is monitoring adverse reactions to medicines and one of the methods of monitoring is collecting and analysing adverse reactions reported from patients themselves alongside the regular reports from healthcare professionals and manufacturers. All reported adverse reactions become part of the documentation on safe use of the medicine, based on which recommendations are provided for the most effective and safe medicine utilisation (doses, warnings, contraindications). These recommendations are included in the Package Leaflet that in inserted in every product packaging and that may be found on our Website.
If you are worried that some symptom that you have developed is actually an adverse reaction, please undertake the following:
- Read the Package leaflet again. In the leaflet you will find expected adverse reactions and advice what to do if an adverse reaction occurs.
- Talk to your doctor or pharmacist about the suspected adverse reaction, who will provide you with an expert advice and tell you what to do next (i.e. stop the treatment, lower the dose or continue the treatment etc.).
- You may report your problems via On-line application for adverse reaction reporting or via Application form for Adverse reaction reporting for patients/users directly to HALMED. HALMED will analyse the report and include it in the documentation on the safe use of the medicine and enter it into the medicinal product database. Your information may help us to change the way of use of the medicine in order to avoid or minimise the adverse reaction occurrence. You may report adverse reactions that occur to you, your child or persons under your custody. Instructions on how to use the application form may be found on the reverse side of the application form that you may open in word or pdf format:
The application form may be completed by hand or on your computer and sent to the following address:
Agency for Medicinal Products and Medical Devices (HALMED)
Ksaverska cesta 4
HR-10 000 Zagreb,
or via fax on: +385 1 48 84 110,
or as an attach via e-mail to: email@example.com
IMPORTANT! HALMED cannot provide individual medical consulting about the treatment, and the patients are advised to talk to their doctors or pharmacists about issues related to the individual therapy.