Pravni aspekti rada Agencije za lekove i medicinska sredstva i značaj za sigurnost lekova

Mujović Zornić, Hajrija and Milenković, Marko (2012) Pravni aspekti rada Agencije za lekove i medicinska sredstva i značaj za sigurnost lekova. Pravni život, 61 (9). pp. 409-432. ISSN 0350-0500

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Abstract

This article analyses some legal aspects of Medicines and Medical Devices Agency of Serbia activities. The first part looks into Agency’s legal position, establishment and competences gained in the European integration process and harmonization with the relevant acquis. The second part analyzes an important aspect of Agency work in terms of controlling drugs’ effects. Medicines and Medical Devices Agency of Serbia was established with a number of important administrative competences in pharmaceutics area. For the patients, the most significant aspect of Agency’s work is to monitor and safeguard the drug safety in accordance with the relevant regulatory framework. The Serbian Medical Law has been continuously developing mechanisms for control of introduction and usage of new medicines, expanding the Agency’s competences as national regulatory body in the area. In accordance with the Law on Medicines and Medical Devices, the Agency is entrusted with establishing specialized bodies. One of these is National Pharmacovigilance Centre. The safety of medicines and medical products has become an imperative in both usage and clinical trials of future products. This raises some challenging legal and ethical issues of drugs usage and prevention of unwanted medicines effects and possible health damage. The paper offers some preliminary suggestions for further enhancement of this important control function of the agency and relevant legislative alterations.

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