Government procurement under 44-FZ: procurement of medicines from sole suppliers and other changes in 2024
Background
The amendments to the Law on Contract System (44-FZ regulating public procurement) will come into force in 2024, which will primarily affect single suppliers and expand the use of the Unified Information System (Internet portal of public procurement).
Termination of procurement from a single supplier (anti-crisis norm)
On 8 March 2024, the following grounds for procurement from a single supplier will be applicable:
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medical devices and consumables manufactured by a single manufacturer in the Russian Federation or in a "friendly" state;
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medicines or medical devices that have no Russian analogues and which production is carried out by a single manufacturer from a "friendly" state, and the purchase is made from a single supplier from a special register (however, the decree on such a register approved by the Government of the Russian Federation became invalid already in August 2022);
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technical rehabilitation equipment and services in electronic form by the Social Fund of Russia, produced/provided in the Russian Federation or produced in "friendly" states
Rule on procurement from a single supplier
The rule on the possibility of purchasing from a single supplier (i.e. without a tender) has also been introduced for medicines and medical devices if it is a joint-stock company or a state unitary enterprise owned 100% by the relevant entity. Such procurement may be carried out by the executive authorities and state institutions of the relevant region where such supplier is located.
The customer must notify the supervisory authority of such a purchase no later than 1 working day from the date of contract conclusion.
The Regulation enters into force on 1 July 2024.
Expansion of the use of the Unified Information System
A number of significant changes in this part are expected on 1st of April:
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customers will be obliged to form a draft contract using the UIS. This applies to contracts concluded as a result of electronic procedures, notices of which were posted in the UIS and invitations to participate in them were sent after 01.04.2024.
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The provision that a contract signed using the UIS shall be sent to the register of contracts using this system no later than 3 working days from the day following the day of its signing shall start to apply.
At the same time, the start of application of the Unified Information System for the conclusion of agreements on amendment and cancellation of the contract concluded as a result of electronic procedures has been postponed from 01.07.2024 to 01.01.2025
MAGENTA Legal lawyers have extensive experience in legal consulting in the pharmaceutical and healthcare sectors, including for such well-known companies as Galderma and Pentax Russia. Our clients also include drug manufacturers and pharmaceutical distributors from Russia, Belarus and Latvia. Our lawyers have successfully assisted clients in international level projects on disputes with such companies as AstraZeneka, Merck and many others, including in proceedings in international commercial arbitration and foreign courts.
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