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Drug Access to Pharmaceutical Market: Changes are Coming

The Ministry of Health prepared a draft of law suggesting the change of the principle of drug and immunobiological drug access to the Russian market.

The nature of change is that in case of approval of the amendments,  it will be allowed to sell drugs after obtaining the approval of Roszdravnadzor. Certificates issued by accredited test laboratories, currently used by Pharma companies to declare drugs, will be insufficient.

Authors of the draft of law give reasons on the need for such decision by laboratories that issue certificates, are private and it is difficult to control them. Besides, the active mechanism of drug access to the pharmaceutical market does not comply with requirements of the Eurasia Economic Union.

Complaints from Pharma manufacturers concerning delay in issue of certificates by laboratories did not lead to supply delays.

Discussion of the project will continue till November, 9.

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