The next changes have taken place in the medicines marking system (the "System"). Decree of the Government of the Russian Federation dated 2 November 2020 No. 1779 "On Amendments to the Regulation on the Monitoring System for the Movement of Medicines for Medical Use" ("the Decree") was published yesterday and consolidated measures that have been repeatedly discussed over the past several weeks in the pharmaceutical sector.
What legal relations does the Resolution apply to?
The regulation applies to all actions with medicinal products from 1 July 2020.
What has been changed?
Now pharmacies and medical institutions will be able to withdraw medicines from circulation through cash desks and disposal registrars immediately after notifying the System about the medicines received by them. There is no need to wait for confirmation from the System that the receipt information has been successfully registered.
Also, from 3 November 2020, the subject of the circulation of medicines has the right to carry out operations with medicines if the System has not provided a response about data processing within fifteen minutes.
In addition, until 1 July 2021, mechanisms for "reverse acceptance of drugs" are introduced for their import into Russia and circulation within the country: importers may not wait from the holders or holders of the registration certificate for medicines to confirm the import.
This information will be automatically confirmed by the System itself by checking the product code and participant data. This will increase the speed of drug transactions for all participants, as it reduces dependence on delays on the side of medicine suppliers.
How long is the Resolution valid?
The transitional period established in the Decree will last until 1 July 2021.
In addition, another important news was published for the subjects of medicines circulation: the CRPT decided to issue and trace codes for all drugs produced from November 2020 to February 2021, free of charge. In the event that this decision of the CRPT is confirmed by a regulatory legal act, we recommend that the subjects of medicine circulation sign addendums to the agreement with the Operator-CRPT on the provision of services for the provision of marking codes in order to amend the clauses of the agreement regarding payment for the above services.
Команда TA Legal Consulting
Нина Белозерцева, Советник
Антон Иванов, Младший юрист
