National treatment for the purchase of medicines: difficult issues sorted out by experts
Specialists are PROGOSAKAZ.The Russian Federation has prepared clarifications on the most controversial situations that arise when purchasing medicines under 44-FZ. The focus is on the application of restrictions, work with the register of Russian industrial products (RRPP) and the specifics of the description of the object of purchase.
1. If one participant has declared his Russian origin, and the other has provided a registry entry
Subject to the established restriction, an application containing a declaration of conformity (subparagraph "c" of paragraph 4 of RF PP No. 1875) is recognized as foreign and rejected on the basis of paragraph 4 of Part 12 of Article 48 of Law No. 44-FZ. The priority remains for the application with the registration record.
2. Notification of the absence of goods in the RRPP (item 433)
The notification is sent in respect of all medicines included in item 433 of the list, regardless of whether they are included in the list of VED or not. If the product is missing in the specified position, the availability of production in the Russian Federation is checked using a Single Structured Catalog of medicines (ESCLP).
3. Do I need to specify aggregated dosage forms in the notification?
No, the notification specifies the dosage forms and dosages in accordance with ESCLP. Links to the "new aggregated forms" are not required.
4. Declaration for alternative dosage forms and multiple dosages
If the description of the purchase object provides for alternative dosage forms or multiple dosages, then the requirement of Part 1.1 of Article 33 of Law No. 44-FZ is considered fulfilled if there is at least one delivery option in the RFPP. There is no need to declare absence for each individual option.
5. Purchase of the national assembly from a single supplier in accordance with clause 6, Part 1, Article 93
From July 1, 2025, the conclusion of a contract with a single supplier under clause 6, part 1, Article 93 is possible only if there is a corresponding decree of the Government of the Russian Federation. The regulations of the constituent entities of the Russian Federation are no longer applied for these purposes. Prior to the approval of such an order, purchases of medicinal products are carried out either by competitive means, or according to clauses 4 and 5 of Part 1 of Article 93 of Law No. 44-FZ.
These clarifications will help to avoid typical mistakes and apply the national regime taking into account all legal requirements.