The Order of the Ministry of Health of Russia of January 25, 2019 No. 23n “On approval of the Administrative Regulations of the Ministry of Health of the Russian Federation on the provision of state registration services for medicines intended for circulation on the general market of medicines within the Eurasian Economic Union, in accordance with the Rules for Registration and Expertise of Medicines means for medical use, approved by the decision of the Council of the Eurasian Economic Commission of November 3, 2016 No. 78 “has been published. The document was registered by the Ministry of Justice on March 14, 2019, No. 54047.
According to the published information:
– the period of registration and examination of the drug should not exceed (in the case of a decentralized procedure) 210 calendar days; in the case of mutual recognition procedure – 210 calendar days (registration in the reference state), registration in the recognition state – 100 calendar days from the date of submission of the application for registration of a medicinal product specified in clause 19 of the Regulations until the date of placing the information in the Unified Register of the Union and issuing the registration certificates;
– the term for making changes to the documents included in the registration dossier of the registered medicinal product is 90 calendar days from the date of receipt of the documents specified in clause 23 or 24 of the Regulations;
– the deadline for making a decision on cancellation of the registration certificate of a medicinal product and exclusion of a medicinal product from the Unified Register of the Union is 5 working days from the day of occurrence of one of the grounds specified in paragraph 160 of the Registration Rules;
– the period of re-registration of the medicinal product is 120 calendar days from the date of submission of the application for re-registration;
– the deadline for bringing the registration dossier of a medicinal product in accordance with the requirements of the Union is 100 calendar days from the date of submission of the relevant application;
– The deadline for issuing a notice of refusal to register a drug is 10 business days from the date of such a decision.