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Importing medical products into the Russian Federation
COREX Logistics expert series In a new series of articles COREX Logistics experts provide useful information in relation to clinical logistics. This article features information about importing medical products into the Russian Federation.
Any medical product imported into Russia must be registered by the Ministry of Health of the Russian Federation. However, in a situation where the life of a particular patient depends on taking a drug that is not registered in the registry, it is necessary to obtain a special permit after a professional consultation of doctors. If the patient's medical facility is located in Moscow, it independently prepares and submits the set of documents to the Ministry of Health. If the patient is being treated in their own region, first a local consultation of doctors must be arranged, and then documents can be submitted to the Federal authorities. This service is free of charge and takes no more than 5 working days, and payment for the drug is usually made directly by the Ministry of Health.
In order for the process to run smoothly it is important that a specific process be followed, and documents carefully prepared in advance. There are many bureaucratic subtleties within the process and clear and correct record-keeping is of vital importance throughout. For example, one of the conditions for importing an unregistered drug is to control the patient's treatment. The medical facility is required to submit a report on the results achieved and the side effects that have occurred. It is also necessary to keep a clear quantitative record of the drugs used, since the loss of even one of its units entails criminal liability.
In addition, there may be cases whereby the necessary medicine does not have the appropriate certificate but is already located in Russian territory. In this case, the permission to use the drug is issued by the company conducting the registration procedure. Only the patient's written consent may be required. This can significantly reduce the waiting period for receiving medication, and possibly save lives.
It is important to understand that medicines that have not been certified in the Russian Federation do not exclude the occurrence of unforeseen consequences, both during and after treatment. It is necessary to get acquainted with the data of the conducted studies in detail and assess the identified risks, since sometimes the expected results do not justify themselves due to the occurrence of concomitant diseases.
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