50 days left to the official start of the all-Russian labelling according to the new requirements of the Decree of the Government of the Russian Federation No. 1954 published on January 9, 2020 amending Resolution No. 1556.
The worldwide situation associated with the threat of the spread of coronavirus has led to quarantine restrictions, which negatively affects the possibility of launching the Drug Movement Monitoring (DMM) system on time.
At the end of March, the Association of Russian Pharmaceutical Manufacturers sent a letter to the Chairman of the State Duma Vyacheslav Volodin with a request to set a stop time for the implementation of system till the end of pandemic.
The Chamber of Commerce and the Russian Union of Industrialists and Entrepreneurs also proposed to postpone implementation of mandatory labelling of medicinal products. Many pharmaceutical manufacturers are in favour of the postponement.
Today, most of them are facing the problems setting up the equipment:
foreign manufacturers cannot come to Russia to verify production processes, and local cannot go abroad for an internship, suppliers delay the manufacture of mechanical parts of equipment necessary for modernisation.
At the same time, number of pharmaceutical companies declare their readiness to start labelling on July 1. Some large distributors prepared to accept labelled products.
Difficulties in the implementation of the system are also reported by many pharmacies and hospitals, which, in this period, already have an increased load.
Some participants of the pharmaceutical market believe that it is not necessary to postpone implementation of the system by the manufacturers who are already prepared. This will allow to test performance of the system throughout the chain.
“Their experience will make it possible to overcome possible difficulties in the future,” said Olga Klygina, general director of Velfarm LLC.
At the same time, the Association of Russian Pharmaceutical Manufacturers emphasises the need for the transitional period (a period without fines) until July 1, 2021 for those who, due to objective reasons, could not be prepared on time. Most market participants support this position.