July 20, 2022
Registration of medicines in the Republic of Belarus
The Republic of Belarus, along with Kazakhstan, Kyrgyzstan, Armenia and Russia, is part of the EAEU. This is of great importance for such an activity as the registration of medicines, since from July 1, 2021, the national registration procedure in Belarus (and other member countries of the Union) is no longer applied, and all medicines must be registered according to the requirements of the EAEU. Nevertheless, as in any other country of the EAEU, Belarus has some features, which will be discussed in this article.
If Belarus is selected as a reference country in the frame of the approval procedure for a medicinal product under the mutual recognition procedure, then an application for registration and a dossier must be submitted to an expert center (Center for Expertise and Testing in Healthcare of the Ministry of Health of the Republic of Belarus). Before that, you must register on the center's website by sending a request with a power of attorney for the right to represent the interests of the applicant). From March 2022, dossiers can be submitted entirely electronically.
The Expert Center carries out an initial examination of the dossier ($109), as well as a specialized one, the cost of which depends on the type of a drug (for the original, innovative, biological, high-tech, orphan drug - $5,916, for other types of drugs - $4,295). In addition, for each additional dosage, packaging and each additional manufacturer of the active pharmaceutical ingredient (API) in the dossier, an additional fee ($ 147-640) is provided.
In order to register a drug in Belarus, the applicant, in addition to submitting a dossier, must also conclude an agreement for a set of technical works with an expert center, which will specify all the conditions for interaction and the cost of work as part of the registration of a medicinal product.
For example, in the Russian Federation this stage is absent. Only proof of payment of state fees must be attached to the dossier. In addition, the amount of the fee does not depend on the type of drug, the number of dosages and packaging.
The registration procedure itself is harmonized for the EAEU member countries and is carried out in accordance with the requirements of Decision No. 78. You can read more about this in our section “Pharmaceuticals for human use”.
- Decision of the Council of the Eurasian Economic Commission dated November 3, 2016 N 78 (as amended on March 17, 2022) "On the Rules for Registration and Examination of Medicinal Products for Medical Use"
