Over-the-counter (OTC) Medicines
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 medicinal product 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.
In addition, OTC medicines must have an extremely positive safety profile and they must be proven safe for use in self-medication.
The OTC status can only be given to those medicines for which a prior visit to the doctor is not necessary, because they are intended for the short-term treatment of symptoms/conditions that patients can easily recognize on their own and are intended for diseases or conditions that do not require necessary medical supervision.
For medicines approved through the centralized authorisation procedure (CP), the evaluation of the application for OTC status is carried out by the European Medicines Agency (EMA) for all EU member states.
For medicines in mutual recognition procedures (MRP), decentralized procedures (DCP) and national procedures (NP), the decision on the prescription status and dispensing status of the medicine is made by national regulatory authorities. In the case of Croatia, the decision is made by the Agency for Medicinal Products and Medical Devices (hereinafter HALMED).
The applicant, along with the application for marketing authorisation, proposes the prescription status and dispensing status of the medicine and is obliged to submit documentation justifying the proposed status. Marketing authorisation holder may, during the life cycle of the medicine, request a change in the prescription/dispensing status of the medicine by submitting the application for variation.
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 taking into account the standards prescribed below and the regulations.
HALMED also determines the medicinal product 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.
The decision on the prescription and dispensing status of the medicine is made by HALMED on the basis of a review of the benefits and risks of medicine in the proposed conditions of use, which include the route of administration, the strength, the active substance, therapeutic indications, the target population, the highest single and daily dose, the duration of treatment, packaging, and in accordance with the valid regulations of Croatia and the valid guidelines of the European Commission and the recommendations of the Expert Group for the Classification of Medicines of the Council of Europe:
- Medicinal Products Act (Official Gazette No. 76/13., 90/14. and 100/18., in the following text referred to as the Act)
- Ordinance on Granting Marketing Authorisations for Medicinal Products (Official Gazette No. 83/13., 28/20. and 32/21.)
- Ordinance on Benchmarks for the Classification of Medicinal Products and on the Prescription and Dispensing of Prescription Medicinal Products (Official Gazette No. 86/13., 90/13., 102/14., 107/15. and 72/16.)
- Recommendations of the Expert Group for the Classification of Medicines of the Council of Europe (appendices Committee of Ministers Resolution CM/Res(2018)1 on the classification of medicines as regards their supply (superseding Resolution ResAP(2007)1 on the classification of medicines as regards their supply), available in MelClass base
- Guideline on changing the classification for the supply of a medicinal product for human use, the Rules governing Medicinal products in The European Community, Notice to Applicants, Volume 2C (valid guideline of the European Commission)
- CMDh Best Practice Guide for authorisation of non-prescription medicines in the Decentralised and Mutual Recognition procedures
- Guideline on Legal status for the supply to the patient of centrally authorised medicinal products (EMEA/CHMP/186279/2006)
- Instructions for preparing a mock-up of the packaging of the medicinal product
Criteria for determining the legal status:
Article 109 of the Act defines that medicinal products shall be subject to medical prescription where they:
- are likely to present a danger either directly or indirectly, even when used correctly, if utilized without medical supervision, or
- are frequently and to a very wide extent used incorrectly, and as a result are likely to present a direct or indirect danger to human health, or
- contain substances or preparations thereof, the activity and/or adverse reactions of which require further investigation, or
- are normally prescribed by a doctor to be administered parenterally.
Medicinal products not covered by the criteria from paragraph 1 of this Article may be dispensed without medical prescription.
The aforementioned criteria for determining the legal status of the medicinal product are described in more detail in the European Commission guidelines, Part I (Guideline on changing the classification for the supply of a medicinal product for human use, the Rules governing Medicinal products in The European Community, Notice to Applicants, Volume 2C).