Current Requirements for Information Content and Graphic Design of a Medicinal Product Package

Abstract

Labeling is an important source of information about a medicinal product. The completeness and accuracy of labeling ensures correct identification, as well as safe and efficacious use of the product. The aim of the present paper was to perform comparative analysis of requirements for the design of medicinal product packages currently applicable in the Russian Federation and in the Eurasian Economic Union (EEU) in order to facilitate the introduction of Russian medicinal products into the EEU market. The EEU requirements for medicinal product labeling are described in laws and regulations stipulating medicinal products circulation in the EEU. The Russian requirements are laid out in Federal Law No. 61-FZ «On medicines circulation» dated April 12, 2010, the State Pharmacopoeia of the Russian Federation, and the Guideline on Medicinal Products Evaluation of the FSBI «SCEEMP» of the Ministry of Health of Russia. It was demonstrated that labeling requirements described in the EEU and Russian regulations largely overlap, but there are also a number of differences that are mainly related to the information on the medicinal product composition and different interpretation of the term «herbal medicinal product». A successful promotion of Russian medicines in the EEU market will require harmonisation of definitions and requirements used in the Russian legislation with those stipulated in the EEU regulations.