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Harmonization of medicines registration procedures in Eurasian Economic Union
The Russian Ministry of Health has proposed amendments to the procedure for registering medicines in accordance with the agreements of the Eurasian Economic Union (EEU)*. The aim of the draft law providing for amendments to the Federal law "on circulation of medicines is to harmonize registration rules.
Under these amendments the process of registration of medicines in the EEU becomes unified. From now on there will be no need to register medicines in each individual country of the EEU (including in Russia).
Medicines can be registered in one country under these harmonized arrangements and have access to the entire EEU market.
The member countries of the EEU operate a coordinated policy in the field of circulation of medicines by:
Taking measures necessary for the harmonization and unification of the legislation of the member states relating to the circulation of medicines;
Adoption of uniform rules and requirements for regulating the circulation of medicines;
Harmonization of the legislation of the member states in the field of control (supervision) in relation to the circulation of medicines.
*The document is available on the portal regulation.gov.ru.
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