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The retail sale of medicinal products in specialised shops


In order to ensure the harmonization of the rules on where and how medicinal products can be sold and to provide transparent guidance for market authorisation holders, the Agency for Medicinal Products and Medical Devices shall establish, pursuant to the provisions set in the Medicinal Products Act and following the recommendations of the European Directorate for the Quality of Medicines and HealthCare of the Council of Europe (EDQM), the criteria that medicinal products must meet in order to be sold over the counter in a pharmacy or a specialised shop. The said criteria shall first be set for single-component medicinal products and shall apply to all medicinal products approved in the Republic of Croatia.

The defined criteria for selling over the counter medicinal products containing ibuprofen and paracetamol are available on the HALMED web pages, under the section Medicinal Products/Over-the-counter (OTC) medicines/Retail sale in specialised shops, which is here: