Unregistered GMOs used for state approbation (tests)
- Document symbol
- G/LIC/N/3/UKR/18
- Original language
- English
- Published on
- 19/09/2025
Outline of Systems
Q1. Give a brief description of each licensing system as a whole and, with respect to each, reply to the following questions as relevant, placing all of the material with respect to a given system in sequence together, and using cross references as appropriate when elements which have already been described are also present in another system.
Prior to state registration, GMOs may be released into the environment only for the purpose of state approbation (testing). State approbation (testing) of GMOs in the open system is carried out exclusively on the basis of a permission issued by the Ministry of Economy, Environment and Agriculture of Ukraine.
The permission is issued on a one-off basis for state approbation (testing) of a particular GMO taking into account the environmental impact assessment results and the conclusion of the state sanitary and epidemiological expertise and only after an assessment of the safety of GMO for human health and the environment being conducted.
Purposes and Coverage of Licensing
Q2. Identify each licensing system maintained and state what products, appropriately grouped, are covered.
The system is aimed to ensure biological and genetic safety, an appropriate level of protection for the safe transfer, handling and use of GMOs derived from the latest biotechnology, which may have adverse effects on the conservation and sustainable use of biological diversity.
GMOs used in an open system shall meet the requirements of biological and genetic safety, provided that the intended technology of use is followed. A prerequisite for the use of GMOs in an open system is the availability of methods and techniques for their identification. It is prohibited to release GMOs into the environment without an environmental impact assessment and prior to their state registration.
Q3. The system applies to goods originating in and coming from which countries?
All countries.
Q4. Is the licensing intended to restrict the quantity or value of imports, and if not, what are its purposes? Have alternative methods of accomplishing the purposes been considered and if so which? Why have they not been adopted?
The system does not restrict the quantity or value of imported products.
Q5. Cite the law, regulation and/or administrative order under which the licensing is maintained. Is the licensing statutorily required? Does the legislation leave designation of products to be subjected to licensing to administrative discretion? Is it possible for the government (or the executive branch) to abolish the system without legislative approval?
The legislation under which the permission is maintained includes:
- Law of Ukraine "On the State Biosafety System for the Establishment, Testing, Transport and Use of Genetically Modified Organisms" No. 1103 of 31 May 2007, available at https://zakon.rada.gov.ua/laws/show/1103-16#Text;
- Resolution of the Cabinet of Ministers of Ukraine No. 308 of 2 April 2009 "On approval of the Procedure for issuing permission for state approbation (testing) of genetically modified organisms in the open system", available at https://zakon.rada.gov.ua/laws/show/308-2009-%D0%BF#Text.
This system cannot be abolished without legislative approval.
Procedures
Q6. For products under restriction as to the quantity or value of imports (whether applicable globally or to a limited number of countries or whether established bilaterally or unilaterally):
Q6.I. Is information published, and where, concerning allocation of quotas and formalities of filing applications for licences? If not, how is it brought to the attention of possible importers? Of governments and export promotion bodies of exporting countries and their trade representatives? Is the overall amount published? The amount allocated to goods from each country? The maximum amount allocated to each importer? How to request any exceptions or derogations from the licensing requirement?
Q6.II. How is the size of the quotas determined: on a yearly, six-monthly or quarterly basis? Are there cases where the size of quota is determined on a yearly basis but licences are issued for imports on a six-monthly or quarterly basis? In the latter case, is it necessary for importers to apply for fresh licence on a six-monthly or quarterly basis?
Q6.III. Are licences allotted for certain goods partly or only to domestic producers of like goods? What steps are taken to ensure that licences allocated are actually used for imports? Are unused allocations added to quotas for a succeeding period? Are the names of importers to whom licences have been allocated made known to governments and export promotion bodies of exporting countries upon request? If not, for what reason? (Indicate products to which replies relate.)
Q6.IV. From the time of announcing the opening of quotas, as indicated in I above, what is the period of time allowed for the submission of applications for licences?
Q6.V. What are the minimum and maximum lengths of time for processing applications?
Q6.VI. How much time remains, at a minimum, between the granting of licences and the date of opening of the period of importation?
Q6.VII. Is consideration of licence applications effected by a single administrative organ? Or must the application be passed on to other organs for visa, note or approval? If so, which? Does the importer have to approach more than one administrative organ?
Q6.VIII. If the demand for licences cannot be fully satisfied, on what basis is the allocation to applicants made? First come, first served? Past performance? Is there a maximum amount to be allocated per applicant and, if so, on what basis is it determined? What provision is made for new importers? Are applications examined simultaneously or on receipt?
Q6.IX. In the case of bilateral quotas or export restraint arrangements where export permits are issued by exporting countries, are import licences also required? If so, are licences issued automatically?
Q6.X. In cases where imports are allowed on the basis of export permits only, how is the importing country informed of the effect given by the exporting countries to the understanding between the two countries?
Q6.XI. Are there products for which licences are issued on condition that goods should be exported and not sold in the domestic market?
Q7. Where there is no quantitative limit on importation of a product or on imports from a particular country:
Q7.a. How far in advance of importation must application for a licence be made? Can licences be obtained within a shorter time-limit or for goods arriving at the port without a licence (for example, owing to inadvertency)?
The permission for state approbation (testing) of GMOs in the open system is issued within 45 calendar days following the date of receipt of application. Information on the decision to issue a permission is provided to the applicant in writing within 10 working days.
Q7.b. Can a licence be granted immediately on request?
A permission may be issued in a shorter time frame and depends only on technical capacity of the relevant authority.
Q7.c. Are there any limitations as to the period of the year during which application for licence and/or importation may be made? If so, explain.
Applications can be submitted at any period of the year.
Q7.d. Is consideration of licence applications effected by a single administrative organ? Or must the application be passed on to other organs for visa, note or approval? If so, which? Does the importer have to approach more than one administrative organ?
Consideration of application for a permission is carried out by the Ministry of Economy, Environment and Agriculture. A working group consisting of representatives of state authorities and relevant scientific institutions may be established to verify the information on the safety of GMOs contained in the submitted documents.
Q8. Under what circumstances may an application for a licence be refused other than failure to meet the ordinary criteria? Are the reasons for any refusal given to the applicant? Have applicants a right of appeal in the event of refusal to issue a licence and, if so, to what bodies and under what procedures?
An application for a permission may be refused if:
- scientifically based information on the risk of GMOs to human health or the environment in their intended use is obtained;
- results of the environmental impact assessment and a positive conclusion of the state sanitary and epidemiological expertise, protocols of public hearings regarding the conduct of state approbation (testing) are not available;
- methods and methodologies for identification of GMOs, developed in accordance with international standards and duly approved in Ukraine are not available;
- an incomplete package of documents has been submitted;
- the form and content requirements for the application have been violated;
- the application and accompanying documents contain inaccurate information.
A decision to refuse to issue a permission shall be provided to the applicant in writing within 10 working days. A decision to refuse to issue a permission may be appealed to the district administrative court in accordance with the provisions of the Code of Administrative Proceedings of Ukraine.
Eligibility of Importers to Apply for Licence
Q9. Are all persons, firms and institutions eligible to apply for licences: (If not, is there a system of registration of persons or firms permitted to engage in importation? What persons or firms are eligible? Is there a registration fee? Is there a published list of authorized importers?) a) under restrictive licensing systems? b) under non-restrictive systems?
A legal entity or individual entrepreneur whose activities involvethe handling of GMOs is eligible to apply for a permission.
Documentational and Other Requirements for Application for Licence
Q10. What information is required in applications? Submit a sample form. What documents is the importer required to supply with the application?
To obtain a permission it is required to submit an application in the form set out in Annex 2 to the Resolution of the Cabinet of Ministers of Ukraine No. 308 of 2 April 2009 "On approval of the Procedure for issuing permission for state approbation (testing) of genetically modified organisms in the open system", and relevant documents listed in the Annex 2 to this Resolution, available at https://zakon.rada.gov.ua/laws/show/308-2009-%D0%BF#Text.
When submitting an application, a legal entity or individual entrepreneur may submit a reasoned request to classify certain information as confidential. Information on the potential impact of genetically modified organisms on human health or the environment shall not be considered confidential.
Q11. What documents are required upon actual importation?
At the time of actual importation, a permission from the Ministry of Economy, Environment and Agriculture is required along with other necessary customs documents.
Q12. Is there any licensing fee or administrative charge? If so, what is the amount of the fee or charge?
The issue of a permission is free of charge.
Q13. Is there any deposit or advance payment requirement associated with the issue of licences? If so, state the amount or rate, whether it is refundable, the period of retention and the purpose of the requirement.
No.
Conditions of Licensing
Q14. What is the period of validity of a licence? Can the validity of a licence be extended? How?
The permission is valid for the period of conducting of state approbation (testing), but not longer than five years.
Q15. Is there any penalty for the non-utilization of a licence or a portion of a licence?
No.
Q16. Are licences transferable between importers? If so, are any limitations or conditions attached to such transfer?
Permission is not transferable to another legal entity or individual entrepreneur.
Q17. Are any other conditions attached to the issue of a licence? a) for products subject to quantitative restriction? b) for products not subject to quantitative restriction?
Submission of a document identifying the person receiving the permission.
Other Procedural Requirements
Q18. Are there any other administrative procedures, apart from import licensing and similar administrative procedures, required prior to importation?
No.