News
Rules for Registration and Examination of Medicines amended
At its meeting held on January 22, the Eurasian Economic Commission's Council approved a package of amendments to the Rules for Marketing Authorization and Expert Examination of Medicines for Human Use.
The package includes approaches to regulating the marketing authorization of medicines packaged together with various additional devices, such as administration aids, measuring cups and spoons, means to ensure proper preparation and storage of the medicinal product.
Depending on the type of product included in the package, as part of the marketing authorization application, manufacturers are obliged to provide documents confirming the quality and proper fulfillment of the product's function in dosing and administering the medicine. At the same time, in order to reduce the regulatory burden on applicants, separate marketing authorization of such products as medical device is not mandatory.
The package of amendments also provides for the issuance of a separate marketing authorization certificate for each new dosage form of a medicinal product.
