Medicines
- 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.
Parallel import of medicines is carried out by a business entity holding a licence to import medicines, in accordance with the licensing conditions established by the Cabinet of Ministers of Ukraine, on based on a permit for parallel import of a medicine (hereinafter - a permit).
The decision to issue or refuse to issue a permit, as well as to suspend, terminate or cancel such a permit, shall be made by the State Service of Ukraine on Medicines and Drugs Control.
Purposes and Coverage of Licensing
Q2. Identify each licensing system maintained and state what products, appropriately grouped, are covered.
The system aims to ensure public access to high-quality and affordable medicines that have been authorized and placed on the market for use in the Member States of the European Union or of the European Free Trade Association, which is a party to the Agreement on the European Economic Area.
Q3. The system applies to goods originating in and coming from which countries?
It applies to medicines that have been authorised and placed on the market for use in the territory of the Member States of the European Union or of the European Free Trade Association, which is a party to the Agreement on the European Economic Area, provided that:
1. the parallel imported medicine is identical or similar to a medicine registered in Ukraine; or
2. the parallel imported medicine and the medicine registered in Ukraine are both reference medicines or both generic medicines in Ukraine and in the exporting country from which the medicine is imported.
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 is not intended to restrict the quantity or value of imported goods. It aims to ensure quality control, compliance with international standards and to expand public access to high-quality and effective medicines authorised in the EU and EFTA. Alternative approaches considered did not guarantee a sufficient level of safety and control over medicines imported as parallel import, nor compliance with international practice.
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 permits are maintained includes:
- Law of Ukraine “On Medicines” No. 2469-IX of 28 July 2022, available at https://zakon.rada.gov.ua/laws/show/2469-20#Text;
- Law of Ukraine No. 3860-IX “On Amendments to Certain Laws of Ukraine on Parallel Import of Medicines” of 16 July 2024, available at https://zakon.rada.gov.ua/laws/show/3860-20#Text;
- Resolution of the Cabinet of Ministers of Ukraine No. 166 "On Amendments to Certain Resolutions of the Cabinet of Ministers of Ukraine on Parallel Imports of Medicines" of 14 February 2025, available at https://zakon.rada.gov.ua/laws/show/166-2025-%D0%BF#Text;
- Resolution of the Cabinet of Ministers of Ukraine No. 73 "On the Approval of the Regulation for Control Over the Compliance of Immunobiological Products Used in Medical Practice with the Requirements of National and International Standards" of 15 January 1996, available at https://zakon.rada.gov.ua/laws/show/73-96-%D0%BF/find?text=%EF%E0%F0%E0%EB%E5%EB#Text;
- Resolution of the Cabinet of Ministers of Ukraine No. 902 “On Approval of the Procedure for State Quality Control of Medicines Imported into Ukraine”of 14 September 2005, available at https://zakon.rada.gov.ua/laws/show/902-2005-%D0%BF#Text;
- Resolution of the Cabinet of Ministers of Ukraine No. 929 "On the approval of the Licensing Conditions for the Conduct of Economic Activity in the Production of Medicines, Wholesale and Retail Trade of Medicines, and Import of Medicines (except for Active Pharmaceutical Ingredients)" of 30 November 2016, available at https://zakon.rada.gov.ua/laws/show/929-2016-%D0%BF?find=1&text=%D0%BF%D0%B0%D1%80%D0%B0%D0%BB%D0%B5%D0%BB#Text, as amended by the Resolution of the Cabinet of Ministers of Ukraine No. 352 “On Amendments to the Licensing Conditions for Conducting Economic Activity in the Production of medicines, Wholesale and Retail Trade of Medicines, and Import of Medicines (except for Active Pharmaceutical Ingredients)” of 28 March 2025, available at https://zakon.rada.gov.ua/laws/show/352-2025-%D0%BF#Text;
- Order of the Ministry of Health of Ukraine No. 698 “The Procedures for Control Over the Compliance of Immunobiological Products Used in Medical Practice with the Requirements of National and International Standards ” of 1 October 2014, available at https://zakon.rada.gov.ua/laws/show/z1356-14#Text;
- Order of the Ministry of Health of Ukraine No. 277 "Some Issues of Implementation of the Law of Ukraine No. 3860-IX "On Amendments to Certain Laws of Ukraine on Parallel Import of Medicines" of 16 July 2024" of 17 February 2025, available at https://zakon.rada.gov.ua/laws/show/z0439-25#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:
The period for issuing or refusing to issue a permit shall not exceed 45 calendar days from the date the applicant submits an application to the State Service of Ukraine on Medicines and Drugs Control, of which no more than:
- 10 calendar days - for the State Service of Ukraine on Medicines and Drugs Control to determine whether there are grounds for refusing the application;
- 30 calendar days - for the State Enterprise ‘State Expert Centre of the Ministry of Health of Ukraine’ (hereinafter - the Centre) to review the materials of the medicine dossier and/or amendments thereto, and to approve the relevant conclusion based on the results of the review;
- 5 calendar days (following receipt from the Centre the conclusion based on the results of the review of the medicine dossier and/or amendments thereto) - for the State Service of Ukraine on Medicines and Drugs Control to make a decision to issue or to refuse to issue a permit.
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)?
No.
Q7.b. Can a licence be granted immediately on request?
No.
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.
No. An application 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?
Upon receiving an application for a permit and the accompanying materials, the State Service of Ukraine on Medicines and Drugs Control shall determine whether there are grounds to suspend consideration of the application or to refuse it.
If no such grounds are found, the State Service of Ukraine on Medicines and Drugs Control shall forward a referral letter to the Centre, along with a copy of the application and the submitted materials, for the Centre’s review and preparation of a conclusion regarding the review of the materials of the medicine dossier for parallel import.
The referral letter shall indicate that, based on data from the Licensing Register and the State Register of Medicines, the State Service of Ukraine on Medicines and Drugs Control has established the following:
- the applicant holds a valid licence for import of medicines;
- the presence or absence of a valid relevant licence to produce medicines held by the applicant (in case of relabelling and/or repackaging of the medicine for placing it on the market in Ukraine for the purposes of parallel import);
- no records exist indicating the expiration or termination of the registration certificate for the reference medicine.
The review of dossier materials/amendments thereto is conducted based on an agreement between the applicant and the Centre.
The procedure for reviewing the materials of the medicine dossier for parallel import and/or amendments thereto is set out in Section IV of the Procedure for Issuing a Permit for Parallel Import of a Medicine, Amending a Permit for Parallel Import of a Medicine, Suspending, Cancelling and Terminating a Permit for Parallel Import of a Medicine, approved by the Order of the Ministry of Health No. 277 of 17 February 2025.
The applicant is not required to submit an application to any other authorities for approval, conclusion or consent.
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?
The application for obtaining a permit and the accompanying materials may be suspended from consideration for the following reasons: incomplete submission of the dossier materials, improper formatting, or signing by an unauthorized person. In such cases, the State Service of Ukraine on Medicines and Drugs Control shall inform the applicant in writing within 3 working days from the date of receipt of the application. If the deficiencies are corrected, the State Service of Ukraine on Medicines and Drugs Control will proceed with the review of the application and the accompanying materials.
A decision to refuse the application for obtaining a permit will be made by the State Service of Ukraine on Medicines and Drugs Control if: the identified deficiencies in the submitted documents are not addressed or are only partially addressed; the information regarding a valid licence for import of medicines is absent in the Licensing Register; the registration certificate for the reference medicine has expired or been cancelled.
In the decision to suspend the application for a permit from consideration and/or in the decision to refuse the application for a permit, the State Service of Ukraine on Medicines and Drugs Control shall specify the reasons (identified deficiencies with reference to the legal requirements violated) that form the basis for such a decision.
The grounds for the State Service of Ukraine on Medicines and Drugs Control to refuse the issuance of a permit, following the review of the dossier materials by the Center, include the identification of non-compliance of the dossier materials and/or the information provided therein with the requirements of the Law of Ukraine "On Medicines" and/or the Procedure for Issuing a Permit for Parallel Import of a Medicine, Amending a Permit for Parallel Import of a Medicine, Suspending, Cancelling and Terminating a Permit for Parallel Import of a Medicine, approved by the Order of the Ministry of Health No. 277 of 17 February 2025, and/or the availability of information indicating the identification of harmful properties of the medicine intended for parallel import into Ukraine, taking into account international practices based on official notifications and/or prohibitions issued by the competent regulatory authorities of foreign countries in the area of market authorization and quality control of medicines.
If grounds for refusing the issuance of a permit are identified, the State Service of Ukraine on Medicines and Drugs Control shall issue a reasoned decision to refuse a permit, which will take effect on the date of its adoption. The decision shall be published on the official website of the State Service of Ukraine on Medicines and Drugs Control no later than 3 working days after it is made.
The State Service of Ukraine on Medicines and Drugs Control shall notify the applicant of the decision to refuse a permit without delay, but no later than 3 working days from the date of the decision, in the manner specified in the application (by registered mail with acknowledgment of receipt to the provided postal address, by courier service at the applicant's request for an additional fee, via email, or through other telecommunication means, or delivered in person).
The decision to refuse the issuance of a permit shall include the following:
- details of the application for a permit;
- information about the applicant;
- a list and explanation of the grounds (justification) for the decision to refuse a permit.
The applicant may submit a new application for a permit to the State Service of Ukraine on Medicines and Drugs Control, either in paper or electronic form, after resolving the issues that were the basis for the initial refusal decision.
The decision on refusal 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 business entity that holds a valid licence to import medicines and submits an application to the State Service of Ukraine on Medicines and Drugs Control for a permit may be considered an applicant.
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?
The application form for obtaining a permit along with the required documents to the application are specified in Annex 1 to the Procedure for Issuing a Permit for Parallel Import of a Medicine, Amending the Permit for Parallel Import of a Medicine, Suspending, Cancelling and Terminating the Permit for Parallel Import of a Medicine, approved by the Order of the Ministry of Health No. 277 of 17 February 2025.
Q11. What documents are required upon actual importation?
At the time of actual importation, a valid licence for import of medicines, a permit for parallel import of medicines, and a quality certificate issued by the manufacturer in the exporting country are required, along with other relevant customs documents.
Q12. Is there any licensing fee or administrative charge? If so, what is the amount of the fee or charge?
The issuance of a permit is not subject to any fees.
A fee is charged for services related to the review of the materials of medicine dossier for parallel import, or any amendments thereto, by the Centre. The amount of the fee is specified in the agreement between the applicant and the Centre.
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 deposit or advance payment is required to obtain a permit.
Conditions of Licensing
Q14. What is the period of validity of a licence? Can the validity of a licence be extended? How?
The permit is valid for five years and automatically expires at the end of this term. To continue the parallel import of the relevant medicine thereafter, the parallel importer must obtain a new permit. Suspension of the permit does not pause its five-year validity period.
Q15. Is there any penalty for the non-utilization of a licence or a portion of a licence?
There is no penalty for non-utilization of a permit.
Q16. Are licences transferable between importers? If so, are any limitations or conditions attached to such transfer?
Permits are not transferable between importers.
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?
A valid licence for import of medicines (excluding active pharmaceutical ingredients) is required.
Other Procedural Requirements
Q18. Are there any other administrative procedures, apart from import licensing and similar administrative procedures, required prior to importation?
After obtaining the permit, the parallel importer is required, within 15 calendar days, to provide the marketing authorisation holder in the exporting country with printed samples of all sides of the packaging (primary and secondary) in cases of relabelling or repackaging of the medicine (provided the relevant manufacturing license is held), or a printed sample of the label in the official language if the original foreign packaging is used, along with an insert in the official language and additional labelling (also subject to holding the relevant manufacturing licence).