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RESOLUTION OF THE CABINET OF MINISTERS OF UKRAINE

of September 26, 2024 No. 1121

Some safety issues and verifications of medicines

For the purpose of prevention and counteraction to turnover of counterfeited medicines the Cabinet of Ministers of Ukraine decides:

1. Approve enclosed:

Regulations on national system of verification of medicines;

Procedure for drawing security aids on medicine packaging, determination of their characteristics, means of check and establishment of requirements to enciphering, structure and format of information which security aids contain.

2. Determine that:

Items 2, 5-8, 11, of 12, 14-18 Regulations on national system of verification of medicines are applied by public authorities and subjects of managing from the effective date of this resolution;

other Items of the Regulations on national system of verification of medicines and procedure for drawing security aids on packaging of medicine, determination of their characteristics, means of check and establishment of requirements to enciphering, structure and format of information which security aids contain are applied by subjects of managing:

on a voluntary basis since January 1, 2026, but not earlier than availability of the corresponding technical capability in national system of verification of medicines. Technical capability in national system of verification of medicines arises from the date of promulgation on the official website (web page) of the National organization for verification of medicines of information on introduction in continuous (industrial) operation of centralized storage of data of National system of verification of medicines;

without fail since January 1, 2028.

The medicines introduced into circulation till January 1, 2028 without drawing security aids on their packaging can be implemented in Ukraine before the expiration of their validity.

3. Bring in Licensed conditions of implementation of economic activity on production of medicines, wholesale and retail trade by medicines, import of the medicines (except active pharmaceutical ingredients) approved by the resolution of the Cabinet of Ministers of Ukraine of November 30, 2016 No. 929 (The Official Bulletin of Ukraine, 2016, No. 99, Art. 3217; 2021, No. 78, Art. 4933; 2022, No. 79, the Art. 4757), the enclosed changes.

4. To the Ministry of Health till January 1, 2026:

To approve 1):

the list of prescription medicines to which security aids without fail are not applied;

the list of OTC medicines to which security aids without fail are applied;

2) to bring own regulatory legal acts into accord with this resolution.

5. This resolution becomes effective from the date of its publication, except Items 2 and 3 of the changes approved by this resolution which become effective since January 1, 2026.

Prime Minister of Ukraine

D. Shmygal

Approved by the Resolution of the Cabinet of Ministers of Ukraine of September 26, 2024 No. 1121

Regulations on national system of verification of medicines

General part

1. This Provision determines bases, procedure for forming and functioning of national system of verification of medicines.

2. The terms used in this Provision have the following value:

authenticity of the unique identifier - set of the characteristics of the unique identifier determined according to the procedure of drawing security aids on packaging of medicine, determination of their characteristics, means of check and establishment of requirements to enciphering, structure and format of information which security aids, No. 1121 "Some safety issues and verifications of medicines" approved by the resolution of the Cabinet of Ministers of Ukraine of September 26, 2024 testimonial of the fact that such identifier conforms to the established technical requirements contain and contains reliable information about medicine;

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