Belarusian hemosorbents enter the markets of the Eurasian Economic Union

Belarusian hemosorbents enter the markets of the Eurasian Economic Union

January 31, 2016 the government signed a law on ratification of the agreement on the treatment of drug and medical device in Eurasian Economic Union (EEU) - this fact opens the EEU space hemosorbents "LPS-Hemo", "Hemo-proteazsorb", "Anti-of IgE-Hemo", "Gemosbel" registered in Belarus ...

Ratification opens up great opportunities for the implementation of hemosobent "Hemo-proteazsorb", "Gemosbel", "Anti-of IgE-Hemo", "LPS-Hemo" in the EEU member-countries markets: Russia, Kazakhstan, Armenia, Kyrgyzstan.

Agreement on common principles and rules for the treatment of medical devices (medical products and medical equipment) in the framework of the Eurasian Economic Union was signed in Moscow on December 23, 2014. The relevant documents are available on the official portal of legal information.

Belarus ratified the agreement July 15, 2015, November 1, 2015 Kazakhstan. November 23, 2015 signing of the Protocols on accession of Armenia has been positively reviewed by the Allied agreement on common principles and rules for the treatment of medical products.

"Common principles and rules for the treatment of medical devices aimed at creating a common market of medical products on the territory of the Eurasian Economic Union These agreements will ensure a competitive environment in the production of medical devices and to ensure proper monitoring of the market." - Said the deputy head of the Ministry of Health head Dmitry Kostennikov.

Agreement on common principles and rules for the treatment of medical devices within the EEU determined transition: documents confirming the state registration of medical devices and issued before the entry into force, acting on the territory of a Member State until the expiry of their validity but not later than December 31, 2021 of the year. 

The purpose of the agreements - the formation of a common market of medical devices within EEU and the removal of unjustified restrictions in mutual trade of Member States EEU.

In accordance with the agreements, Member States of the Union should take the measures necessary for the harmonization and unification of their legislation in the field of medical devices, including in the area of ​​control (supervision) in the field, as well as to adopt uniform rules governing the treatment and the harmonization of medical devices nomenclature  used in the member States EEU, uniform mandatory requirements for safety, efficacy and quality, common approaches to the creation of a quality assurance system.