The FSBI ‘SCEEMP’ official website offers e-services to streamline communication with applicants and ongoing operational activities, as specified in the Federal Law No. 61-FZ ‘On Circulation of Medicines’ of 12 April 2010 and the ‘Rules of Marketing Authorisation and Assessment of Medicinal Products for Human Use’ established by Decision No. 78 of the Eurasian Economic Commission Council of 3 November 2016.
Only authorised users are granted access to Applicant Accounts.
Instructions on gaining access:
Памятка о работе с кабинетом заявителя
Power of attorney forms for gaining access to:
- specific submissions (Annex 1. Power of attorney):
Приложение 1. Доверенность на получение доступа к конкретным заданиям
- all submissions:
Приложение 1. Доверенность на получение доступа ко всем заданиям
The e-service for working with submissions under the Federal Law No. 61-FZ ‘On Circulation of Medicines’ of 12 April 2010: https://lk.regmed.ru/Reg
The e-service for working with submissions under the ‘Rules of Marketing Authorisation and Assessment of Medicinal Products for Human Use’ established by Decision No. 78 of the Eurasian Economic Commission Council of 3 November 2016: https://lk.regmed.ru/EAEUnion
Technical support of the e-service for working with submissions under the ‘Rules of Marketing Authorisation and Assessment of Medicinal Products for Human Use’ established by Decision No. 78 of the Eurasian Economic Commission Council of 3 November 2016: https://lk.regmed.ru/Support?act=new&Section=2
Technical support on the maintenance and updating of the National Register of Medicinal Products: https://lk.regmed.ru/Support
Useful links:
- order R&D products, publications, and pharmacopoeial reference standards: https://lk.regmed.ru/Ntp;
- batch release: https://lk.regmed.ru/ICC;
- workshops and training materials: https://lk.regmed.ru/Edu.