DRUG LABELING REQUIREMENTS IN RUSSIA AND THE EUROPEAN UNION

The regulations for drug labeling and package design were analyzed in the Russian Federation (RF) versus the European Union (EU). The RF and EU legislative acts were established to have important differences: • the holder of a trading license must be indicated in the EU whereas RF Federal Law No. 61-ФЗ on Medicines Circulation (ФЗ-61) dated April 12, 2010 determines the need for writing the name of a drug manufacturer (the definition of a drug manufacturer, which is given in ФЗ offers problems in determining what organization, must be put on the package of a drug); • the EU direction envisages that the immediate packaging must give the international nonproprietary name (INN) of a drug and, if it contains no more than 3 active ingredients, the name of its dosage form whereas the latter and INN may be absent on the primary package in the RF; • the EU regulates Braille duplication of information for people with visual impairments; • requirements for the protective labeling of prescription drugs have been introduced; • the EU legislative act also provides that the user should be informed about the excipients used as components of a drug. In the RF, the requirements adopted in the EU (concerning the indication of a drug manufacturer, the use of Braille, evidence for excipients in the drug labeling, and etc.) are as recommendations (included in guidelines). The authors of the paper consider this to be obviously inadequate having regard to the need to reduce technical barriers in creating the single economic space within the EU.