Top 15 Legislative Changes in the Field of Pharmaceuticals and Healthcare

REVERA Law Group, within its Life Sciences practice, has prepared a structured overview of 15 legislative changes in the field of pharmaceuticals and healthcare, adopted at the EAEU level in 2025.

The material covers changes relating to the registration of medicinal products and medical devices, as well as requirements for research, documentation, labelling, inspections, and pharmaceutical development:

• transition to the registration of medicinal products under the EAEU rules;
• extension of the transitional period;
• amendments to the rules governing the registration and expert evaluation of medicinal products;
• extension of the registration of medical devices under national rules;
• updates in the areas of GLP, GCP, and RWD;
• new requirements for the patient information leaflet and the Summary of Product Characteristics (SmPC);
• changes to the labelling of medicinal products and veterinary medicinal products;
• adoption of guidelines and conceptual (policy) documents at the EAEU level.

The overview brings together all key changes of 2025 in a single document and makes it possible to:

1. see the full list of the adopted regulatory decisions;
2. navigate updates to the EAEU regulatory framework;
3. use the material as a consolidated list of changes.

This information will be of interest to all stakeholders in the medical and healthcare market of the Republic of Belarus, as well as to foreign companies considering Belarus as a jurisdiction in which to do business.

Authors: Sergey Sushchenya, Denis Valyukevich, and Irina Navitskaya.

Download the materials to keep the full list of adopted changes to hand and to use it in your work.

The REVERA legal team is ready to answer any additional questions.