The procedure for registration of medicinal products is transferred to an electronic format
A draft amendment to the law “On the Circulation of Medicines” has been submitted to the State Duma, which should bring Russian pharmaceutical legislation in line with the norms of the Eurasian Economic Union. The document was published on August 3rd.
The main change will be the transfer of the drug registration procedure to an electronic format. All interaction between applicants and regulatory authorities will be carried out through the Unified Portal of State and Municipal Services or using the Unified State Health Information System (EGISZ).
In the current version of Law No. 61 FZ, when registering a medicinal product, the applicant can submit documents in electronic form, but is still obliged to provide copies of them on paper.
In addition, the bill will edit some terminology, bringing it into line with the regulations of the EAEU. So, for example, such terms as “drug based on somatic cells”, “gene therapy drugs for veterinary use” and others will be added to the law.
Also, the mandatory provision on the abolition of state registration of medicines that have not been in circulation for more than three years will be excluded from the law. This is due to the fact that there is no such requirement in the EEAS regulatory framework.
Earlier, the Ministry of Health proposed to completely transfer to an electronic format the issuance of licenses for the circulation of narcotic drugs, psychotropic substances and their precursors, the cultivation of drug-containing plants.