Government Loosens Regulations of Production and Implementation of Medical Products and Drugs

The Government of Serbia has adopted the Decree on special technical requirements, standards and implementation of medical products during the state of emergency.

As said in Article 1 of the Decree, during the state of emergency, medical devices not produced in line with the standards can be procured, used and implemented in medical treatment procedures under the condition that the producer or the distributor files alongside the medical product:

1) a copy of the technical characteristics and the manner of use of the medical product, with a Serbian translation;

2) a statement that the medical product is as effective as the matching product produced in line with the standard;

3) a statement that medical workers to administer the product will be trained to do so;

4) a statement by which they oblige to provide the servicing and the spare parts for the medical product and declare the period of validity of the obligation;

Exceptionally, the translation and the statement from Paragraph 1 can be obtained from the competent organ which assesses harmonization in the Republic of Serbia, before the medical product is obtained, based on the documentation filed by the producer or the distributor.

Article 3

Articles 1 and 2 of this decree apply to medical drugs as well.

Article 4

The procedure of procurement of medical products and drugs in line with this decree is subject to the stipulations of law which regulates public procurement procedures in weather disasters and epidemics of infectious diseases.

Vlada Republike Srbije

Government of Serbia

Decree on special technical requirements standards and implementation of medical products during the state of emergency

medical drug production standards

medical device production standards