The Right for Registration
Amendments have been made into the Statute on the Ministry of Healthcare of the Russian Federation. Governmental Decree No 124 of 02.02.2017 has already been signed by Premier Minister Dmitry Medvedev.
First of all, the attention is drawn to the change in subsection 5.2.149 of the Statement on the Ministry of Healthcare of the Russian Federation. The new version looks as follows: 5.2.149. classification of amendments, introduced into the documents, included into the marketing authorization dossier for an authorized medicinal drug.
Besides, according to the changes made, the Ministry has powers to perform marketing authorization of biomedical cell-based products, issue authorizations for import into the Russian federation, attestation of authorized persons of BCP manufacturers, and attestation of experts, who will be responsible for the review.
The Ministry of Healthcare also has the right to perform the procedure of quality expertize of a biomedical cell-based product using equipment of manufacturer, issue of authorization for clinical trials, and maintaining a public register of biomedical cell-based products, as well as a form of specification for a biomedical cell-based product. It will be responsible for suspension of circulation of marketing of medicinal drugs.