Among the most important changes in the regulation of the Russian pharmaceutical industry in the 2nd quarter of 2023, are the following:
- Government of Russia approved the Strategy for the Development of the Pharmaceutical Industry of the Russian Federation for the period up to 2030.
- Within the framework of the Eurasian Economic Union, amendments were made to the Rules for Registration and Expertise of Medicinal Products in terms of the procedure for confirming the compliance of the production site with the requirements of good manufacturing practice of the Eurasian Economic Union.
- The list of Vital and Essential Drugs has been updated in terms of dosage forms of a number of medicinal products.
- New rules for the manufacture and dispensing of medicinal products by licensed pharmacies have been adopted.
- Additional criteria have been introduced for sole suppliers in the framework of public procurement of medicinal products.
- Responsibility is introduced for violating the established rules for dispensing drugs subject to subject-quantitative accounting when they are dispensed without a prescription.
- The Ministry of Health proposed to allow the inclusion of medicinal products used in accordance with indicators (characteristics) not specified in the instructions for their use in the standards of medical care for children and clinical recommendations.
- It is proposed to change some formulas for calculating the maximum ex-works prices for Vital and Essential Drugs.
- A transitional period has been established for integration into the Russian pharmaceutical market of the Donetsk People’s Republic, Lugansk People’s Republic, Zaporozhzhya region and Kherson region.