Ministry of Industry and Trade prepared a draft on amending the Regulations of the Russian Government No. 1289 of 30 November 20151.
Under the draft the drugs from the List of Strategically Important Drugs produced in a foreign country shall be rejected to supply by the customer if there is at least one offer to supply a drug produced (all manufacturing stages) exclusively in the territory of the Eurasian Union member states.The List of Strategically Important Drugs includes the following 15 INN:
- Lamivudine / Zidovudine
- Insulin glargine
- Insulinum lisprum biphasicum
- Thioureidoiminomethylpyridinii perchloras
To prove the compliance of the drug from the List with the requirements the supplier shall submit a document containing the information on the manufacturing stages of the drug within the territory of the Eurasian Union. This document is issued by the Ministry of Industry and Trade.
By executing and performing the contract no substitution of a particular manufacturer or country of origin specified in the bid for the supply is allowed.
In our view, the adoption of the amendments will encourage Russian manufacturers to transfer all manufacturing stages of their drugs to Russia or other counties of the Eurasian Union, on the one hand. On the other hand, the draft will limit the presence of foreign drugs on the market.
Public discussion will end on 3 December 2021.1Regulations of the Russian Government No. 1289 of 30 November 2015 “On Limitations and Conditions for Admission of Drugs Originating in Foreign Countries and Included in the List of Vital and Essential Drugs for the Purposes of Procurement for State and Municipal Needs”