To maintain the stability of the pharmaceutical market and provide the population with vital medications, the Russian Ministry of Health has initiated the extension of special procedures simplifying the circulation and registration of medicines and medical devices. This extension extends four key regulations previously introduced to address these special conditions.
Key documents whose validity period is extended:
- Russian Government Resolution No. 593 of April 5, 2022. This document permits the import and sale of medications in original foreign packaging, accompanied by a Russian translation, to promptly prevent market shortages.
- Russian Government Resolution No. 441 of April 3, 2020. Regulates the expedited registration of drugs needed to respond to emergency situations and combat dangerous diseases. Its validity is extended until January 1, 2036.
- Russian Government Resolution No. 430 of April 3, 2020, establishes a special procedure for the circulation of medical devices during military operations, emergency situations, and epidemics. Its validity period has also been extended until January 1, 2036.
- Russian Government Resolution No. 552 of April 1, 2022. Concerns the circulation of medical devices in the event of a shortage or risk of shortage. The period of application of these regulations is extended until January 1, 2036.
The significance of the measures taken:
- Reducing the risk of shortages: Extended standards allow for flexible and rapid responses to potential supply disruptions, preventing critical products from disappearing from pharmacy and healthcare facility shelves.
- Business planning: Manufacturers and distributors receive long-term and clear rules of the game, which contributes to the sector’s investment attractiveness and sustainable market development.
- Protecting the health of citizens: Continuing to provide patients with essential medications and medical devices is a key priority of the extended regulations, which directly impacts safety and quality of life.
Thus, the extension of these regulations is a preventative measure aimed at strengthening the resilience of the healthcare system and guaranteeing the availability of medical products for citizens in the long term.
