On January 19, within the framework of the meeting of the thematic subgroup of the Working Group on the implementation of the “regulatory guillotine” mechanism in the field of pharmaceuticals and medical devices, in which members of the Public Council of Roszdravnadzor Victor Dmitriev, Lilia Titova and Nadezhda Daragan took part, was held a discussion on the draft Decree of the Government of the Russian Federation “On approval of the Regulations on the system for monitoring the movement of drugs for medical use”, prepared by the Ministry of Industry and Trade of Russia.
The drug movement monitoring (DMM) system was launched on July 01, 2022. However, after a year and a half, there are still unresolved issues, as well as new ones related to interdepartmental interaction and inconsistencies in the databases of departments. This not only complicates the work of the participants in the process, but also, most importantly, does not allow the smooth operation of the DMM system. Today, the system allows you to support fiscal functions, but does not guarantee that unaccounted products will enter the system. The experience gained during the operation of the system showed the need to make adjustments to the regulatory framework that ensures its operation. That is why the Ministry of Industry and Trade has prepared a new version of the Regulations on the DMM system. The document is being discussed and aims to reduce the burden on business through the exclusion of illogical and unreasonable procedures that divert the financial and labor resources of the business, to ensure the transparency of the system that prevents the possibility of counterfeit and low-quality products entering circulation.
“Currently, work continues with regulatory authorities to amend the current legislation. At this stage, a new version of the Decree of the Government of the Russian Federation No. 1556 dated December 14, 2018 is being discussed in order to secure the right for manufacturers and distributors to receive information about the movement of products online, — said a member of the Public Council, Executive Director of the Union of Professional Pharmaceutical Organizations Lilia Titova. — We hope that the opinions of the pharmaceutical market experts will be taken into account by regulatory authorities and appropriate amendments will be made to the current legislation. Thus, the right to receive information on the presence of residues and the movement of drugs throughout the country will be secured.”
Experts believe that an uninterrupted system will allow not only planning the production and supply of products, but also promptly responding to emerging «overflows» and defects, and ensure the availability of medicines anywhere in the country.
“Unfortunately, the current system does not provide control and the impossibility of opening packages,” said Victor Dmitriev, Chairman of the Public Council of Roszdravnadzor. “Today, based on the data from other industries, we can track the movement of boxes with codes, and not the products that are in them. Shoe manufacturers are already ringing bells about this. I think we need to think about that too.”
Discussion of the work of the monitoring system for drugs for medical use is planned by the Public Council for April 2022. In the meantime, the discussion of the draft Decree continues.