Article 11. Preclinical Testing of a Medicine for Medical Use

1. A preclinical testing of a medicine for medical use is conducted using scientific assessment methods for the purpose of obtaining evidence of safety, proper quality and efficacy of the medicine.

2. A preclinical testing of a medicine for medical use is conducted in compliance with the good laboratory practices approved by the authorized federal executive body.

3. Developers of medicines may involve research institutions and institutions of higher professional education, which have a necessary material and technical base and qualified specialists in the relevant research area, to arrange and conduct a preclinical testing of a medicine for medical use.

4. A preclinical testing of a medicine for medical use shall be conducted in accordance with the plan approved by the developer of the medicine with the trial protocol keeping and generating a report which should contain the trial results and conclusion on the possibility of a clinical trial of the medicinal product for medical use.

5. Inspections for compliance with the good laboratory practices and statutory regulations on the use of animals in preclinical testing of medicines for medical use shall be carried out by the authorized federal executive body.

6. The results of a preclinical testing of a medicine for medical use may be submitted to the authorized federal executive body in accordance with the standard procedure for the purpose of state registration of the medicinal product.