There is a number of legislative acts regulating drugs importation process on the territory of the Russian Federation: the Federal Law No. 61 dated 12.04.2010 "On Circulation of medicines"; the Resolution of the Government of the Russian Federation of 29.09.2010 No. 771 "About an order of drug importation for medical application on the territory of the Russian Federation";the Agreement dated 18.06.2010 "About an order of goods movement by individuals for private use through customs border of the Customs union and commission of customs operations, connected to their release".
Importation of drugs for commercial purposes
As a general rule drugs imported into the territory of the Russian Federation have to be included in the register of medicinal preparations. If there is an importation of drugs intended for clinical trials, for examination for state registration or for rendering health care to the specific patient, you must obtain special permission of Ministry of Health of the Russian Federation. Medicines must be certified by the manufacturer verifying their compliance with the requirements of pharmacopoeial monographs or normative documents or regulations.
In order to import the drug for the individual patient it is necessary to provide the confinement of consultation apart from basic documents. This document must be processed in an organization which renders medical care to the patient. Besides the confinement it is necessary to provide the application of the authorized body of the territorial subject of the Russian Federation confirming that the import of this medicine is necessary to the patient. The certified copy of the patient’s identity document also has to be attached.
In all cases, the Ministry of Health is obliged to consider the application for permission within no more than 5 working days. The law established only two bases on which the Ministry of Health may refuse to issue a permit: the presence of incomplete or inaccurate information in the documents; prohibition of the medical use of the drug in the territory of the Eurasian Customs Union.
The application for a permit shall be registered in a special register of issued permits, which is maintained by the Ministry of Health of the Russian Federation.
Import of the forged, substandard or counterfeit drugs is forbidden, and this ban extends also to the individuals.
Drugs can be imported by:
1) producers for own drug production purposes;
2) foreign developers and manufacturers of medicines or other legal entities on behalf of the developer to conduct clinical trials, the state registration, the inclusion of the pharmaceutical substance in the state register, quality control of drugs with the permission of the Ministry of Health for the import of a particular batch of medicines;
3) wholesale drug company;
4) research and educational organizations, manufacturers of medicinal products for the development, research, security control, quality control, efficiency control with the permission of the Ministry of Health;
5) health care organizations and other organizations rendering medical care forlife-saving indicationof a particular patient with permission of the Ministry of Health.
Import of drugs for personal use and other non-commercial purposes
The drugs may be imported into Russia without the permission of the Ministry of Health and other requirements imposed for legal entities and without registration if they are intendedfor:
1) personal use by individuals who came to the territory of the Russian Federation;
2) the use of employees of the diplomatic corps and representatives of international organizations accredited in the Russian Federation;
3) treatment of passengers and crew members of vehicles, train crews and drivers of vehicles arriving in the Russian Federation;
4) treatment of participants of international cultural and sports events and participants of international missions;
5) treatment of specific animals in zoos, as well as animals imported into the Russian Federation to participate in sports and entertainment events;
6) use in the international medical cluster.
It is necessary to consider that since June, 2016 there is a new norm of the Federal Law No. 61 limiting the import of virulent and (or) toxic substances which, however, was not included in the rules of drug importation approved by the Government of the Russian Federation.An individual should be prepared to provide certified copies of documents or certified extracts from them to confirm the appointment of imported drugs. Actually that document is a recipe, although there is no direct name of the document in the legislation. The document should contain information on the name and number of the appointed medicine. The documents made in a foreign language should be translated into Russian and notarized. The rule does not apply to the medicines that are registered in the Russian Federation and arereleased without recipe. The list of these drugs can be found in the list of virulent substances, and the list of toxic substances, approved by Government Decision of December 29, 2007 No. 964.
A similar ban has long existed in the EU, where there are also restrictions on the import of drugs. Since the drugs are virulent, the customs and border control authorities often have questions about the purpose for which a particular drug is imported. After all, perhaps, a personis transporting the drugs across the border not for the treatment but for the other purposes: resale, obtaining narcotic effects.In fact, the establishment of this provision should not affect most people that import drugs. However it is better to pay attention to the formulation of the imported drug for the presence of virulent and toxic substances.
Illegal transportation of virulent and toxic substancesthrough border of the Customs union is equated to smuggling now. According to the article 226.1 of the Criminal Code of the Russian Federation this crime prescribes punishment for transportation of such medicines for individuals in the form of imprisonment for a period of three up to seven years or a penalty in the amount up to 1 million rubles.
by Maria Nikitina, junior associate of BRACE Law Firm