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Clinical Trials

The Agency shall supervise the conduct of a clinical trial with the provisions of this Law, regulations passed in accordance with this Law andwith regard to requirementsof the Guidelines for Good Clinical Practice in Clinical Trials.

The clinical trials applicant shall be entitled to request the Agency to perform an inspection of the clinical trials of the medicinal product in institutions where clinical trials are performed.

Medicines and Medical Devices Agency of Serbia issues the Authorisations for Clinical Trials too, to the manufacturers of innovative medicines and devices whose companies are registered outside Serbia. The aplications usualy concern the III a. and b. and IV phase of clinical trials, i.e. for medicines and devices in development phase, and medicines and devices already marketed. The documentation is assessed by the experts employed at the Agency or independent experts advisers to the Agency. The Committee for clinical trials assessment for medicines and medical devices for use in human medicine reviews the documentation and expert reports and advises the Agency on clinical trials authorising in compliance with EU Directive 2001/20/EC. Auditing of authorised clinical trials is performed in compliance with the Directive and ICH guidelines.

In authorising clinical trials a very thorough and highly professional assessment of the requested study is done to assure safety of patients involved and when it is possible to provide conditions for timely and financially accessible inovative therapy for a number of patients that would otherwise not have accessibility to such a treatment.

Clinical trials of medicinal products are tests on individuals, aimed at determining or confirming the clinical, pharmacological or pharmacodynamical effects of the medicinal product or products being tested, identifying adverese reactions to one or more tested producs, tesing resorption, distribution, metabolism andextraction of one or nore medicinal products in oreder to determine their safety, i.e. efficiencys.

The objectives of clinical trials referred to in Para. 1 of this Article, also refer to tests of medicinal products that are used in veterinary medicine on animals.

Clinical trials of medicinal products shall be conducted in accordance wth guidelines for Good Clinical Practice in Clinical Trials.

Medicinal products shall be clinically tested based on results of pharmaceutical and pharmacological-toxicological testing.

Medicinal products used in human medicine shall be tested in accordance with principles of ethics and with obligatory protection of personal data on individuals participating in the testing.

Medicinal products used in veterinary medicine shall be tested in accordance with veterinary ethics and animal protection principles. Medicinal products used in clinical trials must be produced in accordance with the Guidelines for Good Manufacturing practice and marked with a label: “For Clinical Trials”.