Registration of medicinal products in the EAEU
A medicinal product is defined as a substance or a combination of substances that interacts with the human body and is intended for the treatment or prevention of diseases, as well as for the restoration, correction or modification of physiological functions through pharmacological, immunological or metabolic mechanisms. This category also encompasses products used for the diagnosis of human diseases and pathological conditions. Given the critical role such products play in protecting public health, their admission to the EAEU market is subject to strict regulatory control and mandatory state registration.
What types of medicinal products need to be registered?
The registration procedure for medicinal products is governed by Decision of the Council of the Eurasian Economic Commission No. 78 of 3 November 2016 "On Rules for Registration and Examination of Medicinal Products for Medical Use". The principal objective of this regulatory framework is to ensure that the population across all EAEU member states has access exclusively to safe, effective, and high-quality medicinal products. Registration within the EAEU offers significant strategic and commercial advantages for manufacturers:
- Access to a unified market covering 5 countries with a total population of over 180 million people
- A single registration certificate valid across all EAEU member states, eliminating the need for separate national approvals
- Reduced time and costs compared to registering in each country individually
- Strengthened market position and competitive advantage over non-registered products
- Legal protection against counterfeit and unauthorised analogues
- Increased trust from healthcare professionals, regulators, and end consumers
- Simplified customs clearance and unobstructed product circulation across EAEU borders
- Long-term business stability backed by a recognised regulatory status
Adherence to the established registration requirements guarantees the legal circulation of medicinal products across all five EAEU member states and serves as a fundamental assurance of their quality, safety, and therapeutic efficacy for patients and healthcare providers alike.
- Original (brand-name) medications
- Generic medications
- Biosimilar medications (follow-on biologics, biosimilars)
- Hybrid medications
- Medications with well-studied medical uses
- Herbal medicinal products
- Orphan medications
- Radiopharmaceuticals
- Products with new combinations of active substances with additional dosing or in other forms
