Registration of medicinal products in the EAEU

A medicinal product is a product that is or that contains a substance or a combination of substances that comes into contact with the human body, intended for the treatment or prevention of human diseases, or for the restoration, correction or change of its physiological functions through pharmacological, immunological or metabolic effects, or for the diagnosis of human diseases and conditions.


What types of medicinal products need to be registered?

The procedure of registration of medicinal products is regulated by Decision of the Council of the Eurasian Economic Commission No. 78 dated 03 November 2016 “On Rules for Registration and Examination of Medicinal Products for Medical Use”, and the main purpose of registration is to guarantee the provision of the population with safe, effective, and high-quality medicinal products.

According to the current rules, the following medicinal products are subject to mandatory registration:

  • 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

Registration stages:

Preparation of a permit to import samples
Import of samples
Submission of a contract to a state body; approval, signing, and submission of a dossier
Initial expert examination. Evaluation of the completeness and correctness of the documents prepared
Specialised expert expertise. Evaluation of the completeness and correctness of the documents prepared
Laboratory tests. Conducting tests, which are carried out in accredited testing laboratories
Scheduled/unscheduled inspection, if necessary, in the cases established in Decision 78
Expert report on the evaluation of the medication by the reference state
Receiving the registration certificate
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