G/TBT/N/UKR/285  
2 February 2024  
(24-0834) Page: 1/3 
Committee on Technical Barriers to Trade  Original:  English  
 
  
NOTIFICATION  
The following notification is being circulated in accordance with Article 10.6  
 
1. Notifying Member:  UKRAINE  
If applicable, name of local government involved (Article 3.2 and 7.2):   
2. Agency responsible:   
Ministry of Health of Ukraine  
Name and address (including telephone and fax numbers , email and website 
addresses, if available) of agency or authority designated to handle comments 
regarding the notification shall be indicated if different from above:   
3. Notified under Article 2.9.2 [X], 2.10.1 [  ], 5.6.2 [X], 5.7.1 [  ], 3.2 [  ], 7.2 [  ], 
other :  
4. Products covered (HS or CCCN where applicable, otherwise national tariff 
heading. ICS numbers may be provided in addition, where applicable):  Medicines  
5. Title, number of pages and language(s) of the notified document:  draft Resolution 
of the Cabinet of Ministers of Ukraine "Some Іssues of Safety and Verification of Medicinal 
Products"; (22 page(s), in Ukrainian)  
6. Description of content:  the draft Resolution of the Cabinet of Ministers of Ukraine 
"Some Іssues of Safety and Verification of Medicinal Products" is developed in order to 
establish and ensure the effective operation of the national system of verification of 
medicinal products and to assure that manufacturers apply safety features to the 
packaging of the medicinal product.  
In order to approximate the EU legislation on preventing and combating the circulation of 
counterfeit medicines and to effectively prevent and combat the circulat ion of counterfeit 
medicines it is proposed to implement the verification of medicines - the 2D coding system 
for medicines.  
Thus, the draft Resolution provides for approval:  
1) the Regulation on the national system of verification of medicinal products (h ereinafter 
- the Regulation); and  
2) the Procedure for application of safety features to the packaging of medicinal products 
and their use.  
The Regulation on the national system of verification of medicinal products defines the 
principles, procedure for the formation and functioning of the national system of 
verification of medicinal products. The purpose of the national system of verification  of 
medicinal products is to facilitate control over the circulation of medicinal products 
exclusively for preventing and counteracting the circulation of counterfeit medicines. The 
Regulation is mandatory for the National agency for verification of medici nal products, 
state control body, owners and/or holders (managers) of information systems, registers, 
databases/data warehouses, all legal entities and individuals engaged in business 
activities in field of medical practice, production, import (except for APIs), wholesale, G/TBT/N/UKR/285  
 
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  retail trade, including distance trade, utilisation and/or destruction of medicinal products 
that: 
1) sold on prescription, except for medicinal products included in the list of prescription 
medicinal products for which safety features ar e are not mandatory;  
2) sold without a prescription, included in the list of over -the-counter medicinal products 
for which safety features are mandatory;  
3) contain safety features applied by manufacturers in accordance with the Procedure for 
application o f safety features to the packaging of medicinal product and their use, 
approved by this Resolution, on a voluntary basis.  
The Procedure for application of safety features to the packaging of medicinal products 
and their use defines the characteristics of t he safety features of medicinal products, the 
procedure for their application, means of verification, encryption requirements (if 
necessary), as well as the structure and format of information to be contained in the 
relevant safety features. Manufacturers shall apply safety features to medicinal products 
in accordance with the provisions of this Procedure. Safety features shall not be applied 
to medicinal products intended for export to countries outside the EU.  
The draft Resolution also stipulates that:  
the requirements of the Regulation in terms of establishing of National agency for 
verification of medicinal products and the national system of verification of medicinal 
products shall apply from the entry into force of this Resolution;  
the provisions of th e Regulation, not specified above, as well as the Procedure for 
application of safety features to the packaging of medicinal products and their use shall 
be applied by business entities:  
- on a voluntary basis from 01 January 2026, but not before the avail ability 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 o f 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.  
7. Objective and rationale,  including the nature of urgent problems where 
applicable:  Consumer information, labelling; Prevention of deceptive practices and 
consumer protection; Protection of human health or safety  
8. Relevant documents:   
Law of Ukraine "On Medicines";  
Commission Delegated Regulation (EU) 2016/161 of 2 October 2015 supplementing 
Directive 2001/83/EC of the European Parliament and of the Council by laying down 
detailed rules for the safety features appearing on the packaging of medicinal products 
for huma n use; Directive 2001/83/EC of the European Parliament and of the Council of 6 
November 2001 on the Community code relating to medicinal products for human use.  
9. Proposed date of adoption:  To be determined  
Proposed date of entry into force:  the Resolution will enter into force from the date 
of its publication, except for subparagraphs 2 and 3 of paragraph 2 of the Resolution, 
which will enter into force on 01 January 2026.  
10. Final date for comments:  60 days from notification  G/TBT/N/UKR/285  
 
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  11. Texts available from:  National enquiry point [X] or address, telephone and fax 
numbers and email and website addresses, if available , of other body:   
Ministry of Economy of Ukraine  
Department for Trade Agreements and Export Development  
12/2 Hrushevskoho Str.  
Tel: +(38 044) 596 6839  
Fax: +(38 044) 596 6839  
Email: ep@me.gov.ua  
Website: https://www.me.gov.ua  
https://moz.gov.ua/article/public -discussions/povi domlennja -pro-opriljudnennja -
proektu -postanovi -kabinetu -ministriv -ukraini --dejaki -pitannja -bezpeki -ta-verifikacii -
likarskih -zasobiv  
https://members.wto.org/crnattachments/2024/TBT/UKR/24_00963_00_x.pdf  
https://members.wto.org/crnattachments/2024/TB T/UKR/24_00963_01_x.pdf  
https://members.wto.org/crnattachments/2024/TBT/UKR/24_00963_02_x.pdf