MPs approve amendments allowing import of medicines without registration in case of epidemics

The document was developed in accordance with the decree of the President “On measures to further improve medical and social assistance to children with rare genetic diseases”.

“Medical devices used in the diagnosis and treatment of rare diseases are produced in leading countries using innovative technologies. From the economic perspective, registration of these products in the Republic is not of interest to manufacturers of these pharmaceuticals,” the press service of the parliament noted.

At discussions of the draft law, deputies noted that it needs to be adopted to prevent problems concerning the import of these products. It would be appropriate to develop a rule for importing these products without registration.

In addition, in order to prevent problems with the import of medicines and medical devices used in the diagnosis and treatment of infectious diseases in the case of epidemics, it would be reasonable to amend the Law, the parliament added. 

The draft law provides for the introduction of the norm “the import of orphan devices can be carried out without their state registration”.

In addition, a rule “in epidemiological situations, medicines, medical devices used in the diagnosis and treatment of infectious diseases can be imported by the Ministry of Health without registration on the basis of approved lists” is to be included in the Law “On Medicines and Pharmaceutical Activities”.

According to the deputies, the adoption of this law will provide opportunities for timely provision of the republic with medical products used in the treatment and diagnosis of rare diseases, import of medicines and in vitro diagnostic products for the prevention, treatment of especially dangerous infections, as well as medicinal means and medical devices for the prevention, diagnosis and treatment of infectious diseases in emergency situations.

The draft law is conceptually approved by the deputies in the first reading.