Overview of Legislative Changes in Pharmaceuticals and Healthcare for Q1 2026

What this material is about

REVERA experts have prepared an overview of legislative changes in the pharmaceutical and healthcare sectors of the Republic of Belarus that entered into force in Q1 2026.

The document covers decisions of Belarusian state administration bodies, as well as regulatory acts adopted within the EAEU framework that directly affect the pharmaceutical industry and the healthcare system.

Who may find it useful

The overview is intended for pharmaceutical companies, manufacturers and distributors of medicinal products and medical devices, healthcare institutions, organisations involved in clinical trials, as well as lawyers and compliance specialists supporting businesses in the life sciences sector.

What is included

The overview contains 10 thematic sections:

• Extension of the transitional period for the registration of veterinary medicinal products in the EAEU until 2030.
• Expansion of the list of medical devices not subject to registration under EAEU rules.
• Updated procedure for conducting preliminary technical work for domestic medicinal products registered under national rules, with a significant reduction in timeframes.
• Changes to the procedure for preferential provision of medicines to citizens, including expansion of the list of diseases for which medicines are provided free of charge.
• Clarifications from the CEHS on the criteria for classifying products used in dental technology work as medical devices.
• Development of sample standard operating procedures for conducting clinical trials.
• Digitalisation of healthcare: designation of the operator of the Central Healthcare Information System and launch of a pilot project involving electronic sick leave certificates.
• Changes to maximum wholesale selling prices for medicinal products.
• Expansion of access to IVF: introduction of two free attempts for Belarusian citizens.
• Updating the regulation of the circulation of narcotic drugs and psychotropic substances.

Why the material is practically useful

Each section of the overview contains specific details of the regulatory act, its effective date and a concise summary of the changes.

This makes it possible to promptly assess which rules are already in force, which require adjustment of internal processes, and to make informed decisions without having to independently monitor scattered sources.

The document was prepared by the Life Sciences practice team of REVERA legal group — lawyers specialising exclusively in pharmaceutical and medical law.

Download the overview to take timely account of current changes in your company’s operational and legal activities and to use it in your work.

Authors: Sergey Suschenya, Denis Valukevich and Iryna Navitskaya.