Draft concept of implementation of public policy for preventing medicines falsification

On March 7^th, 2019 draft decree of the Cabinet of Ministers “On Approval of the Concept of Implementation of Public Policy for Preventing Medicines Falsification” (hereinafter – the draft) was published on the official website of the Ministry of Health.

In particular, the draft prescribes approval of the Concept of Implementation of Public Policy for Preventing Medicines Falsification (hereinafter – the Concept) aimed at determination of mechanisms of preventing falsification of medicines. Its purpose also is to set terms and steps as well as ways within the corresponding time period necessary to implement the effective system of preventing falsification of medicines designated to protect rights of consumers to quality and safe medicines.

In view of reaching the abovementioned goal, the Concept offers to use the following mechanisms:

• gradual implementation of marking packages of medicines with control (identification) signs based on the list specified by the Ministry of Health;
• creation of single system of medicines circulation monitoring;
• verification by consumer of reliability of medicines data.

Compulsory marking with control (identification) signs and monitoring of circulation of all types of medicines is planned to be introduced in 3 stages during 2019-2024.

At the first stage (2019-2020) the following is planned:

• introduction of pilot project on marking with control (identification) signs and monitoring of medicines circulation with assessment of its effectiveness;
• creation and introduction of the program product aimed at ensuring this monitoring;
• consulting with participants of the chain of supplies of medicines from manufacturer to end consumer;
• amending regulatory acts, adoption of legislation necessary to implement the Concept;
• introduction of voluntary marking with control (identification) signs and monitoring of medicines circulation as determined by the Ministry of Health upon the pilot project;
• introduction of automatized system of medicines circulation monitoring and its compulsory use for medicines marked with control (identification) signs.

At the second stage (2021-2023) gradual introduction of compulsory marking with control (identification) signs and monitoring of medicines circulation specified by the Ministry of Health with constant expansion of list of such medicines are planned.

At the third stage (from 2024) it is planned to introduce compulsory marking with control (identification) signs and monitoring of circulation of all medicines types specified by the Ministry of Health as subject to marking.

Thus, implementation of the Concept is expected to have positive influence on life and health of the population, production and circulation of medicines, and also will ensure effective state control at all levels of medicines supply chain.