Article 64. Safety Monitoring of Medicinal Products

1. The medicinal products being in circulation in the Russian Federation shall be subject to the safety monitoring in order to reveal possible negative consequences of their use, to prevent and protect patients against the use of such medicinal products.

2. The safety monitoring of medicinal products at all stages of their circulation in the Russian Federation shall be performed by the authorized federal executive body.

3. Subjects of medicines circulation shall, in the order established by the authorized federal executive body, inform of any and all cases of side effects inconsistent with the information contained in the Package Leaflet for  medicinal products, of serious adverse reactions and unexpected adverse reactions that have occurred when administering the medicinal products, and of particularities of interaction of the medicinal products with other medicinal products that were registered when conducting clinical trials, as well as when administering the medicinal products.

4. Failure to inform on or non-disclosure of the data contemplated in Clause 3 of this Article by individuals to whose notice such information came by the nature of their professional occupation, shall be liable in accordance with the legislation of the Russian Federation.

5. The procedure for conduction of safety monitoring of medicinal products, registration of side effects, serious adverse reactions and unexpected adverse reactions that have occurred when administering medicinal products, including for presentation of information thereof, is to be established by the authorized federal executive body.