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1
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Notifying Member
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Ukraine
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2
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Title of new
legislation/procedure
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The 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
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3
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Date of Publication
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25 February 2025
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4
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Date of entry into force
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25 February 2025
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5
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Website link/Official
publication of the new regulation/procedure
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https://zakon.rada.gov.ua/laws/show/166-2025-%D0%BF#Text
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6
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Have you attached a copy of the
regulation (PDF) to the Secretariat
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[] Yes. (Please attach a copy of the regulation to the notification.)
[X] No.
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7
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Type of notification
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[X] (a) New
licensing regulation/procedure[2];
(please answer question 8 to 14)
[] (b) Changes
to a regulation/procedure which has been previously notified in document: (please answer question 15 and 16)
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8
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List of products subject to
licensing
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30 (HS-22) Pharmaceutical Products
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9
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Nature of licensing
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Automatic: []
Non-Automatic: [X]
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10
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Administrative purpose/measure
being implemented
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(a)
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Protect public morals;
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(b)
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Protect human, animal or plant life and health;
protect environment;
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(c)
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Collect trade statistics or market surveillance;
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(d)
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Protection of patents, trademarks and copyrights, and
the prevention of deceptive practices;
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(e)
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Pursue obligations under the UN Charter and other
international treaties (i.e. CITES, Basel
Convention, Rotterdam Convention, UNSC Resolutions etc.)
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(f)
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Quota (including TRQ) administration;
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(g)
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Regulate imports of arms, ammunition or fissionable
materials and safeguard national security;
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(h)
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Other: ______________ (please specify)
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11
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Administrative body(ies) for submission
of applications
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Ministry of Health of Ukraine
Address: 01601, Kyiv, vul. Hrushevskoho, 7
Website: https://moz.gov.ua/uk
Telephone: +38 044 253 61 94
Email: moz@moz.gov.ua
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12
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Contact point for information
on eligibility
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Ministry of Health of Ukraine
Address: 01601, Kyiv, vul. Hrushevskoho, 7
Website: https://moz.gov.ua/uk
Telephone: +38 044 253 61 94
Email: moz@moz.gov.ua
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13
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Expected duration of licensing
procedure
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Ongoing
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14
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A
summary of the notification in one of the WTO official languages
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The Resolution was adopted following the
provisions of the Law of Ukraine of 16 July 2024 No. 3860 "On Amendments
to Certain Laws of Ukraine Regarding Parallel Import of Medicines".
Clause 78 of the Law of Ukraine of 28 July
2022 No. 2469 "On Medicines" (as amended by the Law of Ukraine No.
3860), provides that the procedure for issuing, amending, suspending,
cancelling or terminating the validity of a permit for parallel import of a
medicine shall be approved by the central executive authority responsible for
the formation and implementation of state policy in the field of healthcare.
Pursuant to the Resolution of the Cabinet
of Ministers of Ukraine No. 166 of 14 February 2025, until the establishment
of the central executive authority with special status responsible for
implementing state policy in the field of development, market authorization,
quality control, safety, and efficacy of medicines, as defined by the Law of
Ukraine No. 2469 "On Medicines" of 28 July 2022:
- the State Service of Ukraine on
Medicines and Drugs Control shall be responsible for making decisions on
issuance or refusal to issue permits for parallel import of medicines, as
well as for suspension, cancellation or termination of such permits, and for
exercising other powers related to state supervision and control over
medicines imported into Ukraine as parallel import, as prescribed by the Law;
- the State Enterprise "State Expert Centre of
the Ministry of Health of Ukraine" shall consider applications and
accompanying documents submitted by business entities for obtaining,
cancelling or amending permits for parallel import of medicines.
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15
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In
the case of 7(b), please indicate the type of new change(s)
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(a)
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Termination
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(b)
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Suspension
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(c)
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Modification of specific
details in existing
procedures:
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Product coverage;
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Administrative
purpose;
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Automatic or
Non-automatic;
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Duration of
licensing;
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Change the nature of
quantity/value restriction;
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Eligibility of
applicants;
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Contact information
on eligibility;
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Administrative
body(ies) for submission of application;
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Documentation
requirements (including application form);
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Period for
Application;
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Administrative
body(ies) to issue licence;
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Processing time for
issuing licence;
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Licence
fee/administrative charge;
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Deposit/advance
payment and relevant conditions;
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Appeal
regulations/procedures;
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Validity of licence;
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Other conditions of
licence (extension, transferability, penalty of non-use etc.);
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Foreign exchange
requirements;
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Other:
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16
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Please
elaborate the changes in detail (in one of the WTO official languages)
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