Continuous safety monitoring of medicinal products
Under the Medicinal Products Act and the current HALMED's price list approved by the Minister of Health, HALMED collects fees for continuous safety monitoring of medicinal products for current marketing authorisations on the market in the Republic of Croatia.
The following is charged once a year, in the month of the marketing authorisation approval date, for all medicinal products that still have a valid marketing authorisation on the approval date, with the exception of medicinal products approved by centralised procedure. Such approach allows financing of the legislation-defined activities of HALMED not covered by the prices of individual HALMED services in the field of medicinal products, which include the following:
- receipt, processing and scientific evaluation of spontaneous suspected adverse reaction reports received from health care professionals and patients/users of medicinal products from the Republic of Croatia
- maintenance of the IT system necessary for monitoring safety of all medicinal products in the Croatian market including:
- the national database on adverse reactions
- local maintenance of the EudraVigilance Gateway (the link to the European database of all adverse reactions)
- maintenance of the system toward marketing authorisation holders
- maintenance of the system toward the WHO adverse reaction database
- electronic system of reporting adverse reactions by health care professionals and patients
- detection of safety signals on the national and EU level
- work of HALMED’s representatives in global competent authorities for monitoring the safety of medicinal products, e.g. in the Program for International Drug Monitoring of the WHO etc.
- work of HALMED’s representatives in the European bodies competent for monitoring the safety of medicinal products (a part of costs is covered from EMA’s pharmacovigilance fees, and another part from HALMED’s fees for medicinal products, or homeopathic medicinal products)
- work in referral procedures as a concerned member state in common EU authorisation procedures
- the informing of health care professionals, patients and marketing authorisation holders on safety issues
- procedure of approval of the local qualified person for pharmacovigilance and the deputy of the local qualified person
- preparation of documentation for safety issues that are discussed at PRAC meetings
- the work of HALMED’s Medicinal Products’ Safety Committee.
