As explained in the Ministry of health, from July 1, Russia has introduced compulsory labelling of digital drugs, but to organizations that due to the spread of COVID-19, was not ready for the new requirements of the law before 1 October provided a reprieve. During the transition period they were allowed the implementation of pharmaceuticals without a digital passport – Data Matrix code if there is approval from the Roszdravnadzor. The agreement will be issued 45 days to the owner or holder of the registration certificate of the goods.
“This procedure will neutralize even a low volume, and number of drugs complexity associated with the entry into circulation of medicines, which may arise from private pharmaceutical manufacturers in connection with the pandemic COVID-19”, – stressed in the Ministry of health. However, the Department drew attention to the fact that permits for the importation and putting into civil circulation of unmarked medications will be issued only in exceptional cases, and manufacturers will have to justify the reasons for non-compliance of mandatory labeling, and to submit the plan of measures on elimination of violations.
to get approval, they will require electronic statement to the Ministry showing the exact quantity of medications and their registration numbers in the state register of medicinal products and all production sites with the addresses at which they are released. In the case of the foreign origin of the product – the 10-digit code of the single commodity nomenclature of foreign economic activity of the Eurasian economic Union.
Additionally, you will need to provide copies of contracts for the supply and installation of equipment for the application of the means of identification of medications, and to inform the exact date of his commissioning. Only after that the application will be reviewed by the special interagency Commission established by the health Ministry, which includes representatives of the Ministry of health, Ministry of industry, Federal customs service. In the event of a positive decision, the information will be sent to the applicant and will appear in the open and publicly available register of approvals of Roszdravnadzor on the Agency’s website.
this temporary order does not apply to medicinal products manufactured after October 1, 2020, as well as the medications from the list of vysokogornyh of diseases for which mandatory labelling was introduced a year ago.
As noted in the Ministry of health, Russian and foreign manufacturers time to prepare for new legal requirements, therefore a temporary order is just an additional measure that will affect a small number of pharmaceutical companies. The Agency also ruled out any problems with the supply of drugs, noting that mandatory labeling will not affect prices for consumers and, on the contrary, in some��which sectors may lead to their decline. In addition, it will help to provide citizens with quality, efficient and safe drugs, will protect the legal market from the counterfeit, ensure the transparency of the turnover of pharmaceutical products, and will also allow you to control the movement of drugs purchased through the budget and expenses on their acquisition.
“the transparency of the market, ousting him of forgery and counterfeiting, and establishing more fair rules of competition will improve conditions for doing business and reduce the number of Supervisory events”, – the message of the press service of the Ministry of health, from which also follows that citizens today can independently verify the legality of pharmaceuticals with applications “Honest SIGN”, which is available free for smartphones. It shows information about the factory, equipment of the package (number of blisters, for example), other data.
