Over-the-counter (OTC) Medicines
In the procedure of granting the marketing authorisation, the Agency for Medicinal Products and Medical Devices (HALMED) classifies the prescription status of the medicine, which means that the product is either a prescription only medicine or not. Those medicines that are not classified as a prescription only are called OTC medicines (from the English "Over the Counter", which would in direct Croatian translation mean "On the Other Side of the Officine", or, colloquially speaking, "Over the Desk").
The same as for prescription only medicines, the OTC medicines are regulated by legislation on medicines and are subject to a highly regulated marketing authorisation procedure by the Agency for Medicinal Products and Medical Devices (HALMED). Every authorised medicine regardless of its prescription status must conform to high quality, safety and efficacy requirements, which means that it must have an approved, stable and repeatable quality, clinical efficacy and respective safe use for patients.
The decision on the prescription status is based on international guidelines and recommendations as well as provisions set out in the Medicinal Products Act related to adverse reactions, indications, needs for doctor's surveillance and the safety profile of the medicine. In other words, the decision on prescription status is made based on the assessment of the entire medicine's profile.
The status of an OTC medicine may be granted only to those medicines for which no previous doctor's recommendation is needed, hence they are intended to treat symptoms/conditions easily recognised by patients and are used for diseases and conditions that do not necessarily require medical supervision and that do have a positive safety profile, in other words their safety is approved for self-medication.
In the procedure of granting the marketing authorisation, HALMED determines the medication dispensing status, which means that an OTC medicine may be dispensed either only in pharmacies, or both in pharmacies and specialised stores for retail sale of medicinal products.
Dispensing medicines that do not require a doctor's prescription facilitates a quicker and easier accessibility to patients, hence the OTC medicines may be purchased with a necessary pharmacist's advice without having previously consulted a doctor, provided the medicine conforms to high standards for dispensing without prescription. Pharmacists have an individual right of refusal in dispensing an OTC medicine for which he or she estimates that it might be harmful to the patient.
OTC medicines may contain one or more active substances (or a combination thereof) and those active substances may be of chemical or herbal origin. Therefore, the OTC status may also be granted to herbal medicinal productsHerbal medicinal product is a medicinal product containing one or more herbal substances or herbal preparations or a combination thereof., traditional herbal medicinal productsTraditional herbal medicinal product is a herbal medicine whose safety and efficacy may be recognised based on its traditional use in either the Republic of Croatia or the EU and which conforms to the requirements set out in the Medicinal Products Act. and medicinal products with a well-established useMedicinal product with a well-established use is a medicine containing one or more active substances with a recognised efficacy and acceptable safety being used for treatment at least 10 years from the first systematic and documented use in either the Republic of Croatia or the EU..
In the renewal procedure of marketing authorisation, or in the case of a new factual evidence, HALMED may reclassify the prescription status of the product by applying provisions set out in the Medicinal Products Act, as well as recommendations of the European Medicines Agency (EMA) and the European Directorate for the Quality of Medicines & HealthCare (EDQM) of the Council of Europe.
There is a Committee of Experts on the legal classification of medicines as regards their supply (P-SP-PHO) at the EDQM, providing recommendations and a harmonised approach of the prescription status of medicines in all Member States of the Council of Europe, including Croatia. Based on the legislation in effect, the Committee of Experts uses a scientific approach in order to set harmonised criteria for classification of medicines that will promote patient safety and a broader availability of medicines to the society. Recommendations for the prescription status of more than 2400 active substances are available on the webpage of the EDQM, which co-ordinates the work of the Committee of Experts.
HALMED will, as always, continue to implement the pharmaceutical acquis communautaire, as well as good practices of the EU Member States related to decisions on the prescription status and dispensing sites.
In this part of our webpage, in the future you will find all the information with regard to regulations and safety of OTC medicines that will be regularly updated with new findings.
Differences between OTC medicines and food supplements
It is important to distinguish OTC medicines from other OTC products, like, for example, food supplements. Food supplements in contrast to medicines do not serve as cure or treatment, as they only contribute to overall health maintenance. Dietary supplements are preparations produced from concentrated sources of nutrientsNutrients are vitamins and minerals, amino-acids, essential fatty acids, fibers, botanicals, herbal preparations, microorganisms, edible mushrooms, algae, bee products and other substances with a nutritive or physiological impact. or other substances having a nutritive or physiological impact with the aim to additionally enrich the usual diet and contribute to overall health, but are not intended to cure diseases. Therefore, they are not subject of the aforementioned marketing authorisation procedure and do not fall under the scope of HALMED's regulations.
Food supplements are regulated by the Food Act and their quality control is focused primarily on the analysis of health or sanitary validity, but not on the evidence-based efficacy as in the case of medicines. Apart from this, while the adverse reaction reporting of food supplements is not mandatory, for all medicines, including those having OTC status, a mandatory adverse reaction reporting and monitoring system has been developed, which means that their safe use is under continuous surveillance.