The Russian Ministry of Health has developed a draft resolution aimed at regulating the import and distribution of original orphan and high-tech medications. The document states that within one year of registration, it will be possible to import these medications in their original foreign packaging.
Import will be permitted subject to registration requirements, except the norms for primary and secondary packaging. A mandatory condition is the presence of a self-adhesive label in Russian on the packaging with key information about the drug (INN, trade name, manufacturer and its address, composition, batch number, production date, storage and transportation conditions, routes of administration, dispensing conditions, warning labels, etc.).
To circulate the drug in Russia, a legal entity will need a conclusion from the Ministry of Health. Each package of the series must be accompanied by instructions for medical use of the drug translated into Russian.