TBT BSN | Notification

Notification Detail :: G/TBT/N/UKR/285/Add.1

Notification No.

Notification Type

Notifying Member

Date of Notification

Final Date for Comments

Days to Final Date

Title

Draft Resolution of the Cabinet of Ministers of Ukraine “Some Іssues of Safety and Verification of Medicinal Products”

Objective

Consumer information, labelling (TBT); Prevention of deceptive practices and consumer protection (TBT); Protection of human health or safety (TBT)

Product Covered

Medicines

Document Notification

Link to ePing

HSCODE

ICSCODE

11.120 - Pharmaceutics; 11.120 - Pharmaceutics

Keywords

Human health; Human health

Specific Regions

Description

Ukraine notifies the adoption of the Resolution of the Cabinet of Ministers of Ukraine No. 1121 "Some Іssues of Safety and Verification of Medicinal Products" of 26 September 2024.The Resolution was published and entered into force on 03 October 2024.The Resolution also stipulates that Clauses 2, 5-8, 11, 12, 14-18 of the Regulation on the National System of Verification of Medicinal Products shall be applied by state authorities and business entities from 03 October 20024; other clauses of the Regulation on the National System of Verification of Medicinal Products and the Procedure for Application of Safety Features to the Packaging of Medicinal Products, Determining Their Characteristics, Means of Verification and Setting Requirements for Encryption, Structure and Format of Information To Be Contained in Safety Features, are applied by business entities: on a voluntary basis from 01 January 2026, but not before the availability of the relevant technical capability in the national system of verification of medicinal products. The technical capability of the national system of verification of medicinal products will be effective from the date of publication on the website of the National Agency for Verification of Medicinal Products of the information on the commissioning of the centralised data warehouse of the national system of medicinal products verification; mandatory from 01 January 2028.Medicinal products put into circulation before 01 January 2028 without the application of safety features on their packaging may be sold in Ukraine until their expiry date.

Notified Document

1:File here

Link to Notification

EN:File here

FR:File here

ES:File here

Status Active

No	#	Comment By	Title	Comment Date	File

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Notification Detail :: G/TBT/N/UKR/285/Add.1

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