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Analysis of the Resolution of the Cabinet of Ministers of Ukraine dated October 8, 2024, No. 1150

General Provisions

Resolution No. 1150 of October 8, 2024, introduces amendments to the previous resolution No. 857 dated July 25, 2024. The main goal of the amendments is to improve the electronic information system for the accounting of cultivated hemp plants for medical purposes, their movement, and processing at all stages of circulation.

Amendments to Points and Subpoints

Point 1

The words “as part of the electronic information system for the accounting of cultivated hemp plants…” have been removed from point 2 of the resolution. Clarification regarding the system component has been added.

Point 2

Changes have been made to the Regulation on the electronic information system, specifically to point 3:

• The fourth subpoint has been removed.
• A new subpoint has been added, defining the premises as the security of the accounting object.
• The subpoints beyond the tenth have been rearranged in accordance with the corresponding changes.
• The definition of “botanical raw materials of hemp for medical purposes” has been modified for clarity regarding its intended use.

Point 10 – 1

Information regarding the interaction of the electronic system with other state registers and information resources has been added, including the Unified State Register of Legal Entities, the medical records register, and others.

Point 20

Subpoint 4 has been removed, and the numbers in subpoint 21 have been changed from “2, 4-6” to “1, 2, 5, 6”.

Point 22

Subpoints have been amended:

• Subpoints 4 and 5 have been removed.
• Subpoint 7 has been revised for clarity regarding the sampling processes.
• The word “crop” has been replaced with “botanical raw materials” in subpoint 10.
• Subpoint 11 has been removed.
• Subpoints 12 and 16 have been revised for accuracy of definitions.
• A new subpoint 23 – 1 has been added regarding the movement of the accounting object.
• The use of accounting objects for educational purposes has been clarified.

Points 52 – 54

Changes have been made to points 52, 53, and 54, where subpoints have been reduced or supplemented to enhance the accuracy of information records regarding operations with accounting objects.

Registration of Operations

Labeling and Packaging

Points 69-70, 74, 80, 81, 105, 109-111, 112-114 include detailed changes regarding the processes of labeling, packaging, manufacturing pharmaceuticals, and other operations with accounting objects. New requirements for the information to be included in the Register have been added, and conditions for the packaging of objects have been established only under certain circumstances.

Transportation and Movement

Points 126-137, 141-147 expand the requirements for information regarding the transportation and movement of accounting objects. Detailed requisites for waybills have been introduced, and obligations for accounting entities to verify the accuracy of the submitted data have been established.

Rejection and Disposal

Point 124 establishes new requirements for the registration of operations related to the rejection of accounting objects, including detailed information about the types, volumes, and storage locations of waste.

Other Operations

Amendments also concern operations related to the production of in-pharmacy preparations, expanding the requirements for information records and establishing new procedures for confirming the accuracy of data.

Requirements for Registration and Confirmation of Operations

The resolution introduces strict requirements for verifying the information submitted by accounting entities and mandatory confirmation of operations in the Register. In case of detection of inaccurate information, the operations are considered unregistered and require re-registration.

Conclusion

Changes to resolution No. 857 are aimed at increasing transparency and control over the circulation of hemp plants for medical purposes. The implemented clarifications and additional requirements ensure a more detailed accounting and regulation of all stages of circulation of accounting objects, from cultivation to final consumption.

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