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Bioequivalence and generic substitution – Croatian regulatory perspective and impact in practice

Croatian regulatory body HALMED, approves medicinal products in Croatia with regard to their quality, safety and efficacy and assess bioequivalence of generic medicinal products as required by EU regulative. When a generic medicinal product is proven to be bioequivalent with the original such generic medicinal product can be replace the reference medicinal product (generic substitution). However, there are original medicinal products that can not be directly replaced with generics such as medicinal products with narrow therapeutic window and variable interindividual absorption, medicinal products with more then two active substances and medicinal products that are applied by medical devices which are used in various ways. These medicinal products are only replaceable in exceptional situations, and only based on a recommendation of a physician that will monitor the condition of the patient during the replacement therapy. In order to ensure a proper information on medicinal products that can be substituted in Croatia, HALMED is to issue a List of Substitutable Medicinal Products.The problem regarding the compilation of such list occured since basic principles for substitution for the medicinal products that have the same active substance are not specified within Croatian Medicinal product Act. In order to ensure the availability of the medicinal products to the patients, if the prescribed medicinal product is not available, the pharmacist is obliged to take measures to obtain the medicinal product within three days. Furthermore, if the pharmacy does not have the prescribed medicinal product due to its unavailability on the market, the pharmacists has the right to dispense the generic medicinal product, under the condition that the authorised person who prescribed the medicinal product did not note on the prescription that the medicinal product may not be substituted, and that the patient is in agreement with the substitution of the medicinal product. In this way supplie chain of medicinal products and availability of medicinal products to patients is intact in the interim period while all the legal requirements for issuance of List of Substitutable Medicinal Products are being fully adapted.

Croatia, bioequivalence, generic substitution, regulatory

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