On 30 January 2024, Federal Law No. 1-FZ was adopted, introducing amendments to Law No. 61-FZ "On the Circulation of Medicines" in Russia. These changes aim to bring Russian legislation with unified requirements within the Eurasian Economic Union (EAEU) and improve existing regulatory frameworks. The Law comes into effect from the day of its official publication, except for provisions with specified timelines. 

According to the new Law, the amendments address various aspects of regulation, including the protection of clinical trial data, electronic government services, registration procedures, etc.  

Significant changes have also been made to the conditions for the circulation of orphan and high-tech medicines, introducing a new definition for high-tech medicinal products and these imports in foreign packages. 

Some significant amendments can also be highlighted: 

• Electronic Document Exchange  

From 1 January 2025, government services for the circulation of medicines will be provided through electronic documents. The decision has been made to completely abandon paper-based document exchange.  

• Extension of Annual Test Protocol Submission Due Dates 

From 1 September 2024, the due dates for the annual submission of test protocols for one batch of medicines released to the market have been extended by 2 months. They will need to be submitted to the Regulator by 1 April. 

• Simplification Procedure for Introducing New Medicines into Сirculation 

From 1 September 2024, manufacturers may provide protocols only for the initial batch of medicines first produced in Russia or first imported, subject to simultaneous execution of the following conditions: 

• Providing a GMP (Good Manufacturing Practice) certificate 
• Absence of instances of non-compliance with established quality requirements for pharmaceuticals on all manufacturing sites of the producer in the preceding three years. 

These amendments, in our view, are aimed at simplifying the registration process and reducing costs associated with bringing medicinal products to market. Despite this, numerous nuances are in the new Law that must be understood to ensure a successful registration process. 

Inpharmatis specializes in the registration of medicines across the EAEU countries (Armenia, Belarus, Kazakhstan, Kyrgyzstan, Russia). The experienced local team provides professional support for medicines registration with the requirements of the Eurasian Economic Union considering all ongoing regulatory changes. 

Receive a personal proposal for medicines registration or request additional information about the services, reach out to us at info@inpharmatis.com.