Answers to frequently asked questions related to the remit of the Croatian Agency for Medicinal Products and Medical Devices (HALMED) are listed below.
In case the answer to your question is not listed below, please feel free to contact us via the "Enquiries” form.
- What is the scope of activities of the Croatian Agency for Medicinal Products and Medical Devices?
Croatian Agency for Medicinal Products and Medical Devices (HALMED) engages in regulatory affairs related to medicinal products and medical devices and conducts all activities and procedures involving the evaluation of their quality, efficiency and safety. Further information regarding HALMED-s activities can be found here.
However, clinical trials of medicinal products and medical devices, their distribution and provision of individual medical advice do not fall within HALMED’s jurisdiction.
Equally, HALMED is not involved in determining the prices of medicinal products and has no authority or influence on forming the list of medicines prescribed at the expense of the Croatian Health Insurance Fund.
- Which medicinal products can be placed on the market in the Republic of Croatia?
According to the Medicinal Products Act (Official Gazette No. 76/13, 90/14, 76/13), only those medicinal products having a marketing authorisation granted by the Agency for Medicinal Products and Medical Devices (HALMED) or the European Commission (EC) may be placed on the market in the Republic of Croatia. Marketing authorisation is granted for those medicinal products demonstrated by scientific assessment to possess an adequate quality, efficiency and safety profile, in line with standards and criteria defined in Croatian and European legislature.
- What are the procedures for granting marketing authorisation in EU member states?
There are four marketing authorisation procedures for medicinal products in the regulatory environment of the European Union: the centralised procedure, decentralised procedure, mutual recognition procedure and national procedure.
In the centralised procedure (CP), the scientific assessment of the medicinal product is conducted by the European Medicines Agency (EMA) and the marketing authorisation valid in all EU member states is granted by the European Commission. Experts from all EU member states, including Croatia, participate in the quality, safety and efficacy assessment of medicinal products.
MRP and/or DCP procedures are based on mutual recognition and recognition of the scientific assessment of one of the EU member states, with the aim to grant marketing authorisations in all other member states where the same application has been submitted.
The decentralised procedure (DCP) for granting marketing authorisation refers to the procedure that starts at the same time in the reference member state and other EU member states participating in the procedure. It is mandatory for those medicinal products that fall outside of the scope of the centralised procedure, that have not been previously granted marketing authorisations in the EU and products that will be on the market of more than one EU member state. This procedure is initiated if the medicinal product has not been previously authorised in any member state and the marketing authorisation holder wishes to place it on the market of two or more member states. In this case, the reference member state assesses the product's documentation for the first time with active participation of all member states concerned.
On the other hand, the mutual recognition procedure (MRP) for granting marketing authorisation starts after a medicinal product has been authorised in the reference member state. According to the marketing authorisation holder's choice, other EU member states may take part in the procedure. It is mandatory for all medicinal products that fall outside the scope of the CP or DCP and that will be on the market of more than one EU member state. In this case the reference member state, where the product has been authorised via national procedure, forwards its assessment report to other member states in the procedure. As in the DCP procedure, following the completion of the procedure, all documents are harmonised (Summary of Product Characteristics, Package Leaflet and Labelling) and the marketing authorisations are granted nationally and valid in all member states that took part in the procedure.
The last, fourth procedure for granting marketing authorisation in the EU is the national procedure, which is carried out when the applicant wishes to market the product in only one member state. In this case, marketing authorisation is granted nationally and is valid only in this member state.
- Which medicinal products are given marketing authorisation via the centralised procedure?
In the centralised procedure, the scientific assessment of the medicinal product is conducted by the European Medicines Agency (EMA) and the marketing authorisation valid in all EU member states is granted by the European Commission.
This procedure is mandatory for medicinal products for HIV/AIDS, cancer, diabetes, neurodegenerative disorders, autoimmune disorders and other immunologic dysfunctions and viral diseases; medicinal products manufactured through biotechnology procedures (i.e. genetic engineering), advanced therapy medicinal products (gene therapy, somatic cell therapy or tissue engineering) and orphan medicinal products. Also, the centralised procedure is possible, but not mandatory for all medicinal products with a significant therapeutic, scientific or technical innovation, or whose marketing authorisation is in the public health interest of the EU, and for generics of centrally authorised medicinal products.
- A medicinal product necessary for my treatment is not available in the Republic of Croatia. How can I obtain it?
In case when the medicinal product necessary for treatment of patients is not available in the Republic of Croatia, HALMED may exceptionally allow the entry or importation of the medicinal product from another country in which it has been approved. A request for approval for exceptional entry is submitted to HALMED by the wholesale distributor, based on an individual medical prescription or a statement by a health institution indicating the need for import of the medicine from abroad. In cases of individual treatment, the procedure is initiated by the physician, by issuing a prescription. The patient brings the prescription, together with other relevant medical documentation, to the pharmacy, which seeks approval for exceptional entry from HALMED via the wholesale distributer. Once the procedure of exceptional entry is completed, the patient collects the medicinal product from the pharmacy.
The procedure of exceptional entry or import of medicinal products is a common practice in other EU member states as well. It is a procedure defined by the Medicinal Products Act as a mechanism to ensure access to medicinal products lacking marketing authorisation, yet necessary for the treatment of patients, via a legal distribution chain. It is important to note that all exceptionally imported medicinal products are manufactured in accordance with valid European regulations and guidelines, possess marketing authorisation in the country from which they are imported and meet the strict criteria of quality, efficiency and safety.
- Can HALMED provide advice on prescribed therapy and patients' medical conditions?
HALMED is not authorised nor it has the resources to provide individual medical advice. Patients should seek advice regarding their therapy from their physicians or pharmacists.
- How can a suspected adverse reaction be reported?
Each suspected adverse reaction can be reported via an online app or form, available on HALMED's website. A detailed description of the procedure of reporting suspected adverse reactions is available on HALMED's website.
- Should I report an adverse reaction listed in the patient information leaflet?
It is particularly important to report a suspected adverse reaction that is not listed in the patient information leaflet, packaged together with the medicine. In this manner, new adverse reactions can be discovered which have not been reported during clinical trials. Although medicinal products have been thoroughly tested prior to obtaining marketing authorisation, certain adverse reactions might only be discovered once the medicine is used in the general population. However, it is important to also report adverse reactions listed in the patient information leaflet as such information reveals their frequency in the general population, or in particular groups of patients, as well as the association of certain adverse reactions with use of other medicines, etc.
- Where can I find the patient information leaflet?
The patient information leaflet is packaged together with each medicinal product. Additionally, patient information leaflets for each medicinal product granted marketing authorisation in Croatia can be found in HALMED's medicinal products database.
- What is the difference between dietary supplements and over-the-counter medicines?
Over-the-counter (OTC) medicines are in HALMED-s remit, whereas dietary supplements are in the remit of the Ministry of Health and the Croatian Institute of Public Health. Furthermore, these two categories of products are regulated separately: OTC medicines are regulated under the Medicinal Products Act (Official Gazette No. 76/13, 90/14, 76/13), and dietary supplements are regulated under the Act on Nutritional and Health Claims and Nutritionally Enriched Food (Official Gazette, No. 39/13). Equally as prescription-only medicines, OTC medicines are regulated under the same legislature on medicinal products, and as such, are subject to a highly regulated marketing authorisation procedure conducted by HALMED, which includes the evaluation of their quality, safety and efficacy. Every authorised medicine regardless of its prescription status must conform to high quality, safety and efficacy requirements, which means that it must have a proven, stable and repeatable quality, clinical efficacy and safety.
Dietary supplements are products that can be freely bought in pharmacies and specialised stores for retail sale of medicinal products, but they are, as their name implies, used solely to supplement the diet and not to treat disease, and as such, only have a role in preserving health.
Dietary supplements are preparations produced from concentrated sources of nutrients or other substances with a nutritive or physiological impact whose aim is to additionally enrich the usual diet and therefore contribute to maintaining health, but not to treat disease. Therefore, they are not subject to the aforementioned marketing authorisation procedure.
Further information on OTC medicines and dietary supplements, as well as on differences between these two categories of products can be found on HALMED's website.
- What are conditions for placing medical devices on the market?
According to Medical Devices Act (Official Gazette No. 76/13), medical devices can be placed on the market, in distribution and can be used in the Republic of Croatia if they comply with the essential requirements taking into account their intended use, if they possess the declaration of conformity and if they are marked with the label »CE«. Further information is available on HALMED's website, in the "Medical devices” section.