Basic information
Outline of the 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 solely on the basis of a permission issued by the Ministry of Ecology and Natural Recourses. The permission is issued on a one-off basis for state approbation (testing) of particular GMO and only after an assessment of the safety of GMO for human health and the environment being conducted.
Product coverage
The system is aimed to ensure biological and genetic safety, an appropriate level of protection in safe transfer, handling and use of GMOs derived from modern biotechnology, which may have adverse effects on the conservation and sustainable use of biological diversity.
GMOs used in an open system must 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 methodologies for their identification. It is prohibited to release GMOs into the environment without an environmental impact assessment and prior to their state registration.
Nature of licensing
Automatic
If Automatic, administrative purpose
Non-Automatic
If Non-Automatic, description of the notified Non-Automatic Licensing regime
Products under restriction as to the quantity or value of imports
The system does not restrict the quantity or value of imported products
Questions for products under restriction as to the quantity or value of imports
Not applicable
The system applies to products originating from which country?
All countries
Expected duration of licensing procedure
Legal requirements
Is the licensing statutorily required?
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" of 2007;
- 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".
Does the legislation leave designation of products to be subject to licensing to administrative discretion?
Is it possible for the government to abolish the system without legislative approval?
This system cannot be abolished without legislative approval
Eligibility of applicants
Is there a system of registration of persons or firms permitted to engage in importation?
What persons or firms are eligible to apply for a licence?
Legal entity or individual entrepreneur, whose activities are related to the handling of GMOs, is eligible to apply for a permission.
Is there a registration fee?
Is there a published list of authorized importers?
Contact point for information on eligibility
Ministry/Authority
Address
Telephone
Fax
E-mail address
Website
Contact officer
Submission of an application
Administrative body(ies) for submission of an application
Documentation requirements
What information is required in applications?
To obtain a permission it is necessary 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, and relevant documents listed in the Annex 2
What documents is the importer required to supply with the application?
To obtain a permission it is necessary 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, and relevant documents listed in the Annex 2
Window of submission of an application
How far in advance of importation must application for a licence be made?
Are there any limitations as to the period of the year during which application for licence can be made? If so, explain
Applications can be submitted at any period of the year
Issuing the license
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.
Can licences be obtained within a shorter time-limit or for goods arriving at the port without a licence
The permission for state approbation (testing) of genetically modified organisms 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 ten working days.
Which administrative body is responsible for approving application of licences?
The consideration of the applications for a permission is effected by the Ministry of Ecology and Natural Recourses
Must the applications be passed on to other organs for visa, note or approval?
To verify the information on the safety of GMOs contained in submitted documents a working group consisting of representatives of the state authorities and relevant scientific institutions may be established
Are there any other conditions attached to the issue of a licence?
Submission of a document identifying the person receiving the permission
Fees and other administrative charges
Is there any licensing fee or administrative charge?
The issue of a permission is free of charge
What is the amount of the fee or charge?
Is there any deposit or advance payment required associated with the issue of licences?
No
Amount or rate?
Is it refundable?
What is the period of retention?
What is the purpose of this requirement?
Refusal of an application
Under what circumstances may an application for a licence be refused other than failure to meet the ordinary criteria?
An application for a permission may be rejected if:
- scientifically substantiated information about the risk of GMOs to human health or the environment in their intended use is obtained;
- there is no positive conclusion of the state environmental and state sanitary and epidemiological expertise, protocols of public hearings regarding the state approbation (testing);
- there are no methods and methodologies for identification of GMOs, developed in accordance with international standards and duly approved in Ukraine;
- an incomplete package of documents is submitted,
- requirements regarding the form and content of the application have been violated;
- the documents contain inaccurate information
Are the reasons for any refusal given to applicants?
A decision to refuse to issue a permission must be provided to the applicant in writing within ten working days
Have applicants a right of appeal in the event of refusal to issue a licence?
A decision to refuse the issue of a permission may be appealed to the district administrative court in conformity with provisions of the Code of Administrative Proceedings of Ukraine.
If so, to what bodies and under what procedures?
A decision to refuse the issue of a permission may be appealed to the district administrative court in conformity with provisions of the Code of Administrative Proceedings of Ukraine.
Importation
Are there any limitations as to the period of year during which importation may be made?
What documents are required upon actual importation?
At the time of actual importation a permission from the Ministry of Ecology and Natural Recourses is required along with other necessary customs documents
Are there any other administrative procedures, apart from import licensing and similar administrative procedures, required prior to importation?
No
Conditions of licensing
What is the period of validity of a licence? Can the validity be extended? How?
The permission is valid for the period of conducting of state approbation (testing), but not longer than five years
Is there any penalty for the non-utilization of a licence or a portion of a licence?
No
Are licences transferable between importers? If so, are any limitations or conditions attached to such transfer?
No
Foreign Exchange
Is foreign exchange automatically provided by the banking authorities for goods to be imported?
No