Pharmaceutical substances in medical devices. Particularities of registration.

Historical background

After the Ministry of Health of the Russian Federation Order № 11n “On approval of requirements to the content of technical and operational documentation of the medical device manufacturer” (hereinafter – the” Order number 11n “) came into effect, marketing authorization, which includes medicines and medical devices containing the same chemicals used in the medicinal means but not related to pharmaceutical substances, became far more difficult.

Consequently item 4.16 of the Order №11n required to disclose “information in accordance with the national registry of medicines for medical use if the medical device contains: medicinal product for medical use, including name (international non-proprietary, or grouping, or chemical and commercial), the manufacturer’s name of the medicinal drug for medical use, date and number of registration certificate of medicinal product for medical use; pharmaceutical substance, including the name(internationally non-proprietary, or grouping, or chemical and trade name) of the manufacturer of the pharmaceutical substance, date and registry number of the state register of medicines funds for medical use;”

Thus, the situation is that the experts from Federal Service for Surveillance on Consumer Rights Protection and Human Wellbeing impose a requirement of mandatory marketing authorization of  drugs and/or pharmaceutical substances used in the composition of the medical product in the Russian Federation.

Current situation

June 13, 2018. The Resolution of the Government of the Russian Federation № 633 “On Amendments to the Rules of State Registration medical products “came into force. This document amended Russian Federation Government Decree of No. 1416, namely, it became obligatory to provide Federal Service for Surveillance in Healthcare with  “copies of quality documents of a drug, pharmaceutical substance, biological material and other substances used to produce medical device or included in its composition and intended to be used according to the in medical purposes specified by the manufacturer and issued in accordance with the legislation of the country of origin of the drug, pharmaceutical substance, biological material and other substances ” during state registration of a medical product.

Order No. 2n and No. 11n of the Ministry of Health of the Russian Federation

have not been amended yet. As the result Orders of Ministry of Health of the Russian Federation are not negotiated with the Russian Federation Government Decree – some require to indicate registration information of drugs or pharmaceutical substances in the Russian Federation; the others – prove their quality with documents issued in accordance with legislation of the country of origin.

Now therefore, according to the registering authority – Federal Service for Surveillance in Healthcare – it is possible by applying the Orders of the Ministry of Health of Russia points No. 2n and No. 11n to meet the requirements established by the Rules in relation to documents confirming the quality of the drug, pharmaceutical substance, and other substances used to produce medical device or included in its composition and intended to be used in medical purposes specified by the manufacturer and issued in accordance with the legislation of the country of origin of the drug, pharmaceutical substances, biological material and other substances.

Summarizing the above,  Federal Service for Surveillance in Healthcare approved marketing authorization of the products, containing drugs or pharmaceutical substances, without submission of documents on their registration in the State Register of medicines, in accordance with the amendments to the Government Decree No. 1416, adopted at the end of May 2018.

However,it is necessary to provide the document on the registration of the substance in the country of manufacture. But it is much easier than registering it, especially in Russia.