For a drug to be imported into the Russian Federation, it must first go through clinical trials and be authorized by the Ministry of Health (MoH). Non-authorized drugs may only be imported under certain prescribed conditions according to the laws of the Russian Federation.
One such exception is the importation of drugs on a “named patient basis” whereby the drug is authorized for a specific patient on the basis of named permission issued by the MoH. In these cases,the life of a patient may depend on the particular drug or medical device. This is the only exception for the commercial distribution of non-authorized medicines.
The importer must obtain permission from the MOH. Permission is granted on the basis of an application supported by documents listed in the Regulations on Performance of the State Function of Issuance of Permissions for the Importation of a Particular Batch of Non-Authorised Medicines into the Territory of the Russian Federation adopted by the Order of the Ministry of Health of the Russian Federation dated 2 August 2012 No. 58.
This service is free of charge and an application must be reviewed by the MoH within five working days. If granted permission is valid for 6 months. In addition, careful documentation must be compiled by the medical facility treating the named patient in relation to the results and side effects that arise from the use of the drug or medical device. Loss of even one unit of the drug incurs criminal liability.
In some cases, the necessary drug or device lacks the appropriate certificate but is already imported into Russia. In this case, the permission to use the drug is issued by the company that conducts the registration procedure. The patient's written consent can be required. This can significantly reduce the waiting period for receiving the medication, and possibly save the patient’s life.
COREX Logistics supports the importation of drugs and devices under the above conditions. Our expert team is highly experienced in navigating all the processes involved and will ensure that vital treatments are delivered to the patient. Find out more about this services and our full range of clinical trial supply and logistics solutions by emailing: firstname.lastname@example.org or visiting www.corex-depot.com.