Changes in the order of examination and registration of medicines

Entered into force on the order of Ministry of Health Care of the Russian Federation №152n 04.03.2014 "About Amendments to Some orders of the Ministry of Health and Social Development of the Russian Federation and the Ministry of Health Care of the Russian Federation."

 Changes relate to the order of examination and registration of medicines.

 In particular, the order of Ministry of the Health Care №750n from 26.08.2010 "About approval of rules for the examination of drugs for medical use and form conclusions of the commission of experts" is amended in accordance with that during the examination of drugs is not allowed to request from the applicant's materials, required for the examination. In case of failure of submissions by experts to give an opinion, the expert raises the question of granting him the necessary materials to the management of the expert institution that handles the corresponding request to the Ministry.

 Amendments to the Administrative Regulations of Russian Ministry of Health Care to provide public services for the state registration of medicines, approved by order of the Ministry of Health Care of the Russian Federation №428n 22.10.2012, specifies the terms and procedure for the examination of documents.