NLMedicalDevices object

Law on Medicines and Medical Devices/ Zakon o lekovima i medicinskim sredstvima (“Sl. glasnik RS” br. 30/2010 i 107/2012), published in the “Official Gazette of the Republic of Serbia” No. 30/2010 dated 7th May 2010; hereinafter referred to as Law on MP & MD 2010

This law determines the performance of the national CA (ALIMS) in Serbia and all significant issues related to medicinal products and medical devices, such as clinical trials, marketing authorization procedure, etc.

Pursuant to Art 199 of this law, clinical investigations on Medical Devices are to be performed in accordance with the provisions of the current Law on conducting clinical trials with Medicinal Products.

Pursuant to Art 78 (par 3), Art 199 (par 3) and Art 161 (par 8) of Law on MP & MD 2010, the Minister of Health implemented this law by adopting the following regulations:

(1) Rulebook on the Contents of the Application, and/or Documentation on the Approval of Clinical Trials for Medicines and Medical Devices, as well as the Method of Implementation for Clinical Trials of Medicines and Medical Devices (hereinafter referred to as “Rulebook Application 2011”)
(Published in the „Official Gazette of the RS”, nr. 64/2011 of 31 August 2011)
It prescribes the content, and/or documentation for the approval of clinical trials for medicines and medical devices, as well as the method of implementation for clinical trials of medicines and medical devices in human medicine.

(2) Rulebook on the method of reporting, collecting and monitoring adverse reactions to medicines (hereinafter referred to as “Rulebook AR reporting 2011”)
The Rulebook was published in the “Official Gazette of RS”, No. 64/2011 of 31 August 2011