Mikhail Mishustin signed the decree about simplification of registration of drugs used in emergency situations for the treatment and prevention of diseases dangerous for people. About it reports “Kommersant”.
For the period of the emergency features of the examination of the quality of medicines may be established by the working group of the Ministry of health. The Agency will be able to reduce the number of examinations or replace them with research.
The registration will be conducted by the Ministry of health within 20 days, within two working days will be issued a task to the expert institution for examination of quality of a medicine and expert examination of the ratio of benefit and risk. An exception is allowed in respect of medicinal products registered in the member States of the European Union, the USA, Canada or another state in the list approved by the Ministry of health. Registration takes five working days.
Also in emergency situations the hospital can’t prescribe medication according to instructions, to examine their effectiveness. The decision will be taken by the medical Commission or the medical Council, be issued by the Protocol and recorded in medical records. After that, the hospital must notify the Ministry of health and Roszdravnadzor, and after application of the drug to report.