In the medical device market, there is a large number of products that contain various chemicals in the composition – active pharmaceutical substances, ancillary substances, as well as precursors of narcotic substances. This article is devoted to the peculiarities of the import of such devices.

1. What are narcotic substances and their precursors?

According to Federal Law No. 3 “On Narcotic Drugs and Psychotropic Substances”, precursors of narcotic drugs and psychotropic substances are substances often used in the manufacture, preparing, processing of narcotic drugs and psychotropic substances included in the List of Narcotic Drugs, Psychotropic Substances and Their Precursors to be Controlled in Russian Federation.

The list of psychotropic substances can be found in Resolution № 681.  Most of the substances found in medical device composition belong to Table II of List IV of the List. According to the Resolution, the circulation of this group of substances in the Russian Federation is limited and general control measures are established in its relation.

General control measures include (Federal Law No. 3 “On Narcotic Drugs and Psychotropic Substances”):

– Establishment of rules of production, processing, sales, acquisition, use, transportation and destruction of precursors (Resolution of the Government of the Russian Federation of August 18, 2010 No. 640)

– Establishment of requirements for reporting on activities related to the circulation of precursors (Resolution of the Government of the Russian Federation of June 9, 2010 No. 419)

– Licensing of foreign trade operations with precursors

– Establishment of requirements to ensure the safety of activities related to the circulation of precursors and exclusion of access to them by unauthorized persons

– Registration of any operations with precursors in special journals

2. What medical products contain precursors of narcotic drugs?

The most common precursors in the composition of MD are methylacrylate and methyl methacrylate. If the product contains 15% or more of these substances, then for the import and circulation of such a product, additional documents must be issued. Methylacrylate and methyl methacrylate are mainly included to bone cement and other dental materials.

In addition, some dental materials include acetone, which is a precursor from Table III of List IV of the List.

3. Required documents.

For the import of products that contain precursors of narcotic drugs, it is necessary to make out not only the import permission ( more about the standard procedure for importing by reference -), but also additional documents:

• The permission of the Ministry of Internal Affairs (MIA) of Russia to import precursors. The term of the service is 15 working days .
• License of the Ministry of Industry and Trade (MinPromTorg) of the Russian Federation. The term of the service is 15 working days .

In conclusion, it is worth noting that in December 2013, the association “Dental Industry” raised the issue of excluding from the list of precursors of narcotic drugs methacrylate and methyl methacrylate, which are the raw materials for the production of inexpensive acrylic dentures. However, this issue has not been resolved, and the import of products containing these substances still causes certain difficulties.

References:

1. Постановление Правительства РФ от 30.06.1998 N 681 (ред. от 22.06.2018) “Об утверждении перечня наркотических средств, психотропных веществ и их прекурсоров, подлежащих контролю в Российской Федерации
2. Федеральный закон “О наркотических средствах и психотропных веществах” от 08.01.1998 N 3-ФЗ (последняя редакция)
3. Постановление Правительства РФ от 18 августа 2010 г. N 640 “Об утверждении Правил производства, переработки, хранения, реализации, приобретения, использования, перевозки и уничтожения прекурсоров наркотических средств и психотропных веществ” (с изменениями и дополнениями)
4. Постановление Правительства РФ от 09.06.2010 N 419 (ред. от 27.06.2017) “О представлении сведений о деятельности, связанной с оборотом прекурсоров наркотических средств и психотропных веществ, и регистрации операций, связанных с их оборотом”
5. Приказ МВД России от 02.08.2017 N 593 “Об утверждении Административного регламента Министерства внутренних дел Российской Федерации по предоставлению государственной услуги по выдаче разрешений Министерства внутренних дел Российской Федерации на право ввоза (вывоза) наркотических средств, психотропных веществ и их прекурсоров”
6. https://vademec.ru/article/ideya_fiksy/