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Clinical Trials DEFINITION
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 adverse reactions to one or more tested products, testing resorbtion, distribution, metabolism and extraction of one or more medicinal products in order to determine their safety, i.e. efficiency.
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 with 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".