Conditions for obtaining of the drugs missing in State Registry

Conditions for obtaining of the drugs missing in State Registry

Russian legislation is very strict in terms of medicinal drugs importation (detailed information is stipulated in the article Features of drugs importation in Russia (Russian language). However, it may happen that a non-registered drug may occur life-dependent for a given patient. In that case special authorization is needed that is issued by Ministry of Health of Russia after doctor’s Concilium. Payment for the drug is typically performed by the Ministry of Health of Russia.

The service is free and is to be performed within 5 working days; however, to grant approval it is important to submit specific documents beforehand. Noteworthy, approval is electronic and e-signed. Such a procedure is nowadays widely spread for the sake of time and efforts.

In real, situation is not so simple and many faced red tape in the way. Globe Medical is rendering the service Named Patient Program (NPP)

Onу more condition to be fulfilled is patient treatment control. Treating Institution is obliged to report of the results or adverse events (complications) and to perform strict accountability of the drug since even one vial missing may give rise to criminal liability.

Conditions and procedure of non-registered drugs’ prescription in Russia

As mentioned before, non-registered drugs may be individually prescribed after doctor’s Concilium.  For that, treating institution prepares submission of specific documents’ dossier to the Ministry of Health of Russia. Approval decision is documented and signed by the Head of the Treating Institution (Head Doctor or Director).

Noteworthy, that the procedure implies treatment to be rendered in Moscow. In case patient is treated in his region, initially local doctor’s Concilium is required which is then followed by a turn to a Federal agency.

Actual context may also reveal that the necessary drug is not duly certified, however is imported in Russia already. Administration approval of the drug in such cases is issued by the registering company. It is only the written consent of the subject that may be required.

Administration of drugs non-registered in Russia

Patient must be well in advance informed of all the drug’s possible risks and side effects by signing informed consent to start treatment; failing that may give rise to criminal liability of the doctor and the Head of the Treating Institution, which entails serious consequences.

It is important to understand that non-certified drugs may cause unexpected relations either before or after treatment. It is necessary to get deeply familiar with the completed studies’ data (please refer to Stages of biological products and drugs studies) and assess the identified risks, since sometimes the expected results are compromised by occurring concomitant diseases. However, there are often cases when the drug saves patient's life despite all the side effects.