News

The Eurasian Economic Commission Council adopted a draft amendment to the Rules for Marketing Authorization of Medicines in the Eurasian Economic Union in terms of introducing a procedure for recognizing, at the initiative of the authorized body of a Member State, the results of marketing authorization of medicines for medical use authorized in other Member States.

The new procedure can be applied by decision of the authorized body if no alternative drug is registered in the national market.

Authorization will not require a fee (or any other established payment for registration) and will be based on the examination performed in the reference state.

The procedure aims to address the problem of ensuring a sufficient range of pharmaceuticals in the Member States with expected low sales volumes that are not commercially attractive to pharmaceutical manufacturers and are therefore not applied for marketing authorization in that Member State. Such drugs are essential to the health care system because they are used to provide medical care (usually in small quantities or infrequently).