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Name – According to the Rules

Russian Ministry of Justice on 03.11.2016 approved an order of the Ministry of Healthcare of the Russian Federation of 29.06.2016 No 429n “On Approval of Rules of Rational Choice of Names of Medicinal Drugs for Medical Use”.

Currently the choice of names of drugs for medicinal use, provided for marketing authorization will be performed strictly according to the rules based on international non-proprietary or group, or chemical and trade name.

It is of note, that INN of the drug is chosen in accordance with names of the active pharmaceutical substances, recommended by WHO, and chemical name – according to classification of International Union on pure and applied chemistry. The group name is chosen in the absence of INN< and if the name is given to a combination of drugs with similar composition of active substances to pool them into a group under  a single name. The trade name of the drug is chosen by manufacturer or marketing authorization holder.

Particular attention is paid to the choice of group name for a combination of drugs. If the composition of the drug includes two or more active substances, it should list INN and(or) group names of pharmaceutical substances in an alphabetic order divided by “+”. If pharmacological activity of one or several pharmaceutical substances does not directly condition the pharmacological effect of the drug, but only plays a supplementary role (lowers side effects of the drug, etc.), the name is specified at the end of the group name in square brackets regardless of the alphabetic order.

To avoid confusion, identical, similar or equivalent names to those already approved are not allowed.

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