New requirements for registration of medicines in Uzbekistan have been established

New requirements for registration of medicines in Uzbekistan have been established

The Ministry of Justice has registered a new instruction on the requirements for documents for state registration of medicines. According to this document, documents for registration of medicines will now be submitted on the basis of the standards of the International Council for Harmonization of Technical Requirements for Medicinal Products for Human Use (ICH).

According to the new regulation, if substances derived from animal raw materials are used in the production of medicines, the presence or absence of prions must be separately indicated in the documents. It is also allowed to include additional information that is not of an advertising nature in the instructions for use of a medicine in medicine based on international requirements.

In addition, information on the presence or use of genetically modified organisms (GMOs) in medicines is also required to be mandatory.