Annual Fees

Under the Medicinal Products Act and the current Fee List approved by the Minister of Health, HALMED collects fees for current marketing authorisations. From annual fees for medicinal products or homeopathic products, depending on the medicinal product type to which a certain product belongs, activities of HALMED as a competent authority for medicinal products in the Republic of Croatia, defined by legislation, are financed, that are not encompassed by individual fees for HALMED’s services in the area of medicinal products. Annual fees serve for financing the obligatory participation of HALMED’s representatives in EU bodies that includes regular active participation in more than 40 committees and working groups in the area of marketing authorisation of medicinal products in the European Medicines Agency, European Commission, Heads of Medicines Agencies, Council of Europe etc.

In these bodies and institutions, HALMED’s representatives participate in:

making decisions and recommendations that are of extraordinary importance for protection of public health of the population of the Republic of Croatia
assessment of documentation for medicinal products authorised for the entire EU territory
referral procedures for harmonising the product information for the entire EU territory
drafting EU-wide guidelines for authorising medicinal products.

Annual fees charged for medicinal products, or homeopathic medicinal products, serve for financing:

procurement of professional and scientific literature necessary for medicinal product assessment procedure
access to scientific databases and applications necessary for conducting the medicinal product assessment procedure
the conducting of educations and training of employees that are necessary to be up-to-date with the latest technical and scientific achievements in the development of medicinal products
maintenance and development of HALMED’s IT system with the purpose of facilitating the processing and monitoring of applications, that includes, among other things, the application for monitoring the status and information if individual applications (National Registry of Medicinal Products), application for processing of electronic documentation on medicinal products (EURS), application for working on electronic document versions resulting from handling submitted applications and their archiving (Digital Archival Information System), as well as other IT applications (Centrix, Pismohrana)
fees that HALMED needs to pay for the maintenance of the common European portal for submission of applications and medicinal product documentation (Common European Submission Platform)
monitoring of the utilisation of medicinal products and promotion of rational use of medicinal products
informing about medicinal products, including public education campaigns
the conducting of meetings of the Committee for Medicinal Products
maintenance of HALMED’s website
international cooperation in the field of medicinal products
work related to European Pharmacopoeia

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
maintenance of the 24-hour rapid alert system on adverse reactions and quality defects that can lead to recalls of medicinal products from the market due to safety reasons
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
procedure for obtaining an external expert opinion as a ground for participation in the work of EMA’s committees
the work of HALMED’s Medicinal Products’ Safety Committee.

Annual fees collected from distribution licenses for medicinal products or medicinal products and medical devices, pharmaceutical manufacturing, brokerage or entry into the registry of manufacturers, suppliers or importers of active substances serve for financing:

maintenance of the IT system necessary for monitoring of participants in distribution of medicinal products, active substances, manufacturers of medicinal products and active substances and medicinal products dispensed on a patient named basis
local national database of participants in the distribution and manufacturers of medicinal products and active substances
local national database for granting approval for enter and import of medicinal products and active substances from third countries not listed by the European Commission
enter and maintenance of data on wholesalers and manufacturers of medicinal products and active substances into the European Medicines Agency’s (EMA’s) EudraGMDP database
enter and maintenance of data on brokers into the Heads of Medicines Agencies’ (HMA’s) Brokers of Medicinal Products Registry
enter of data on conducted pharmacovigilance inspections into EMA’s repository
work of HALMED’s representatives in EMA’s GMP/GDP Inspectors Working Group (GMDP IWG)
participation in meetings of the Pharmaceutical Inspection Co-operation Scheme (PIC/S) Secretariat
work of HALMED’s representatives in the European Commission on adopting new regulations, directives and guidelines related to medicinal products legislation
maintenance of 24-hour rapid alert system on quality defects of medicinal products that can lead to recalls from the market for safety reasons
maintenance of the system for the suspension of distribution of medicinal products and product recall
the informing of health care professionals, patients and marketing authorisation holders on quality defects
the publishing of reports on annual utilisation of medicinal products for the previous year
the informing of EU member states and the European Commission on revoked licenses
preparation of documentation on granted licenses and entry into the registry upon the request of the European Commission’s request or an individual EU member state
maintenance of the system for notification on the placement of medicinal products in the market, shortage reporting and reporting of interruptions in the supply chain
preparation of documentation on request of individual EU member states on medicinal products exported from the Republic of Croatia based on parallel export
receipt, processing and scientific evaluation for granting accords for placing medicinal products in the market the applications of which are pending for renewal.

Annual fees collected from manufacturers and authorised representatives, wholesalers and specialised medical device retail stores support the following activities of HALMED:

receipt, processing and scientific evaluation of adverse incidences associated with medical devices in the territory of the Republic of Croatia
receipt, processing and scientific evaluation of safety corrective actions associated with medical devices, conducted in the territory of the Republic of Croatia
participation in the EU medical device vigilance system - NCAR exchange, monthly teleconferences, Vigilance Enquiry Procedure
processing and scientific evaluation of medical device documentation received via the notification system on the placing of medical devices in the Croatian market
maintenance of the IT system necessary for the system of monitoring the safety of medical devices in the market
national database of adverse incidents and safety corrective actions
maintenance of the database on medical devices in the Croatian market
maintenance of the database on all participants in the process of manufacture and distribution of medical devices
maintenance of the system toward the EU database EUDAMED
receipt of notifications and records of legal and natural persons that conduct pharmacy practice in the Republic of Croatia and offer medical devices for distant sale
work of HALMED’s representatives in the European Commission’s working groups within the international cooperation of EU competent authorities
work of HALMED’s representatives on the development of the EU medical device legislation - Medical Devices Committee, Pharmaceuticals and Medical Devices Council Working Party
work in the harmonisation procedures for classification of medical devices - the Helsinki procedure
work in procedures for monitoring of medical device harmonisation and data exchange on the EU level - the COEN procedure
informing of health care professionals, patients and other interested parties on safety issues
maintenance of the 24-hour rapid alert system on adverse incidences and safety corrective actions associated with medical devices
work of HALMED’s Committee for Medical Devices.