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Information for Applicants

The SCEEMP official website offers e-services to streamline communication with applicants and ongoing operational activities, as specified in Federal Law No. 61-FZ ‘On the Circulation of Medicinal Products’ 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:

Applicant Account Guide

Power of attorney forms for gaining access to:

  • Specific submissions (Annex 1. Power of attorney):

              Annex 1. Power of Attorney for Gaining Access to Specific Submissions

  • all submissions:

              Annex 1. Power of Attorney for Getting Access to All Submissions

  • Guidance on Conducting Remote Interactive Evaluation of Medicinal Products:

              Remote Evaluation Guide, 20 March 2024

The e-service for working with submissions under Federal Law No. 61-FZ ‘On the Circulation of Medicinal Products’ 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 microbial test strains, SCEEMP 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.

Document library

Guidance on the Preparation of a Summary of Product Characteristics (SmPC)
0.6 mb PDF
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Guidance on the Preparation of a Summary of Product Characteristics (SmPC) (new!)
0.32 mb DOC
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Guidance on the Preparation of a Package Leaflet (PL)
0.59 mb PDF
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Guidance on the Preparation of a Package Leaflet (PL) (new!)
0.24 mb DOC
Download
Guidance on Conducting Remote Interactive Evaluation of Medicinal Products (20 March 2024)
0.02 mb DOCX
Download
Guidance on the Deletion of the Abnormal Toxicity Test
0.41 mb PDF
Download