Russian Government proposes to change the existing order for market launch of medications


January 26, 2017. The draft Resolution proposed by the Russian Government named “On the introduction into civilian circulation of drugs for medical use on the territory of the Russian Federation” is intended to exclude medications from a single list of products that are subject to mandatory certification and the list of products, conformity assessment of which takes the form of acceptance of the declaration of conformity.

The document proposes to adopt a new procedure for the market launch of medications for the whole-country circulation. In other words, this sphere of legal relations will be derived from the application of the technical regulation and will be harmonized in accordance with the regulations of the Eurasian Economic Union. The function of control over the implementation of the new order is supposed to be placed on the Federal Service on Surveillance in Healthcare (also known as Roszdravnadzor).

“The draft regulation aims at removing barriers to the release of medications into circulation and reducing the financial burden on producers,” – is stated in the explanatory note to the document.

Market launch of medications (except for immunobiological medicinal products in respect of which a special procedure will be developed) is to be carried out on the basis of information provided by the manufacturers and importers to the Roszdravnadzor’s IT system.

“Thus, the procedure of mandatory conformity, which is obsolete and is essentially a formality, will be canceled,” – the executive director of the Union of Professional Pharmaceutical Organizations Liliya Titova said.