1.What happens to registration certificates obtained by national procedure? EEU Council Decision No. 46 implying discontinuance of registration certificates obtained under the national procedure on...
Author archive for: goryacho
Registration of medical devices. Hot news. Date of mandatory re-registration of medical devices according to EAEU standards will be shifted
So, it happened! The Eurasian Economic Commission has put forward a reasonable and logical proposal to postpone the expiration date of national Registration Certificates for...
RegMed company took part in the conference of UNIDI Unione Nazionale Industrie Dentarie Italiane – Italian Dental Industries Association, Milan, 9 July 2019.
The report was made by CEO Mrs. Inna Stenina on the theme of medical devices registration in Russia. Presentation can be downloaded here.
Marketing authorization of dietary supplements in Russia
Dietary supplements — biologically active food supplements. They are kind of food products that qualify as “natural” biologically active substances intended to be consumed simultaneously...
The Regulation of Ministry of Health of the Russian Federation on drug registration within the Eurasian Economic Union have been issued
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...
Pharmaceutical substances in medical devices. Particularities of registration.
Historical background After the Ministry of Health of the Russian Federation Order № 11n «On approval of requirements to the content of technical and operational...
IMCT in Russia. Aims and peculiarities of conduction.
Today we will talk about IMCTs (international multicenter clinical trials) and about the specialities of their organization and conduction in Russia. Why we need IMCTs,...
GMP inspection of foreign manufacturers. Common problems and their solutions.
Author: Sokolova Elena Borisovna, a leading specialist in GMP inspection. In this article we will talk about a hot issue: how to successfully pass the...
Latest news on labeling drugs
Since February 1, the amendments to the Federal Law No. 61 “On the circulation of medicinal products” came into effect, according to which, from January...
We invite you to take part in master-class “Russian GMP certificate. Procedure. Key points. Recommendations”
Dear guests and participants of IPhEB 2019! We invite you to take part in master-class “Russian GMP certificate. Procedure. Key points. Recommendations” The event will...