The Ministry of health of the Russian Federation is preparing a bill that would force pharmaceutical manufacturers to make the instruction on the drug administration data post-marketing studies, writes “the parliamentary newspaper”.
The relevant amendments, the Ministry plans to amend the law “On circulation of medicines”. To make changes to the manual must be the holder or the owner of the registration certificate of medicines.
The Ministry believed that the new requirements will establish the procedure for granting and accounting of the results of application of drugs in medical organizations, which will increase the effectiveness of the control and safety of the products being in civil circulation.
It is expected that the new rules will take effect in January 2021.