At its meeting held on January 21, the Eurasian Economic Commission’s Council approved an amended version of the Requirements to Patient Information Leaflet and Summary of Product Characteristics.

The main amendments concerned the format of the patient information leaflet (package leaflet): a number of unused sections have been eliminated, making it easier for consumers to obtain information.

The Requirements were also amended to eliminate the need to perform user testing for previously registered medicinal products. This will simplify their transition to the Union’s market segment and enable pharmaceutical manufacturers to reduce the cost of preparing marketing authorization applications according to the Eurasian Economic Union’s rules.