G/TBT/N/UKR/256/Rev.1  
1 November 2023  
(23-7393) Page: 1/2 
Committee on Technical Barriers to Trade  Original:  English  
 
  
NOTIFICATION  
Revision  
The following notification is being circulated in accordance with Article 10.6.  
 
1. Notifying Member:  UKRAINE  
If applicable, name of local government involved (Articles 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 fr om above:   
3. Notified under Article 2.9.2 [X], 2.10.1 [  ], 5.6.2 [  ], 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):  biological 
safety  
5. Title, number of pages and language(s) of the notified document:  draft Law of 
Ukraine "On Biological Safety and Biological Protection"; (32 page(s), in Ukrainian)  
6. Description of content:  the draft Law is developed wi th the aim of gradual creation of 
a unified system of biological safety and biological protection based on "One Health" 
approach, to fulfil obligations to protect the life and health of people and animals, to 
prevent the spread of harmful infectious diseas es in the country, and to respond in a 
timely manner to outbreaks of infectious diseases.  
The draft Law defines the legal, organizational, economic and social principles of biological 
safety and biological protection in Ukraine, in particular:  
introduces a  new conceptual framework for definitions, inter alia, biological safety; 
biosynthetic activity; biological hazard; biological protection; biological risk; biological 
toxin; biological agents; microorganism depository; deposit of microorganism strains; 
state register of entities engaged in activity related to biological agents and biosynthetic 
activities; entity engaged in circulation of biological agents, entity engaged in biosynthetic 
activities; determines the authorized body in the sphere of biological safety and biological 
protection, parties of legal relations in the sphere of biological safety and biological 
protection.  
The draft Law introduces a set of measures aimed at ensuring the protection of people, 
animals, plants and the environment from hazar dous biological factors, identification and 
minimization of biological threats, assessment and effective management of biological 
risks.  G/TBT/N/UKR/256/Rev.1  
 
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  7. Objective and rationale, including the nature of urgent problems where 
applicable:  Protection of human health or safety; Protection of animal or plant life or 
health; Protection of the environment   
8. Relevant documents:  Laws of Ukraine "On National Security of Ukraine", "On Licensing 
of Economic Activities", "On Veterinary Medicine", "On State Control over Complian ce with 
the Legislation on Food, Feed, By -products of Animal Origin, Animal Health and Products 
of Animal Origin, Animal Health and Welfare", "On Transportation of Hazardous Goods", 
"On the State Biosafety System for the Creation, Testing, Transportation a nd Use of 
Genetically Modified Organism"  
9. Proposed date of adoption:  To be determined  
Proposed date of entry into force:  The Law will enter into force 12 months after its 
publication.  
Within two years from the date of entry into force of this Law, entit ies engaged in the 
circulation of biological agents of 3 -4 risk groups are allowed to carry out their activities 
without accreditation, under the condition that they have a license for the circulation of 
biological agents and/or biosynthetic activities.  
10. Final date for comments:  60 days from notification  
11. Texts available from:  National enquiry point [X] or address, telephone or fax 
numbers  and email and website address es, 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 -discussion s/proekt -zakonu -ukraini -pro-biologichnu -
bezpeku -biologichnij -zahist  
https://members.wto.org/crnattachments/2023/TBT/UKR/23_1 3270_00_x.pdf