The Ministry of Industry and Trade of the Russian Federation has developed amendments to the Regulations on the Ministry of Industry and Trade approved by Government Order No. 438 of June 5, 2008, the agency reports. The amendments grant the Ministry of Industry and Trade the authority to approve the rules of storage of medicinal products for human use.
At the moment, the entities involved in the circulation of medicines, including manufacturers, are guided by the departmental acts of the Ministry of Health on storage issues.
“At the same time, storage at production sites is also regulated by the GMP rules of the Eurasian Economic Union approved by the decision of the Council of the Eurasian Economic Commission No. 77 of November 3, 2016,” the Ministry of Industry and Trade reports.
The ministry plans to issue a departmental act, which will oblige pharmaceutical companies to store their products in accordance with the rules of the EAEU, as well as, if necessary, the establishment of specific storage requirements for certain categories of medicines, e. g., those containing potent substances.
“The changes were developed with the support of the Ministry of Health of Russia and a working group that included representatives of the expert and business community for the implementation of the “regulatory guillotine” in the field of pharmaceuticals and medical products. They are aimed at eliminating the redundancy in the medicines storage requirements for manufacturers,” the Ministry of Industry and Trade commented in its statement.