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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. 352
"On Amendments to the Licensing Conditions for Conducting Business
Activities for the Production of Medicines, Wholesale and Retail Trade in
Medicines, and Import of Medicines (except for Active Pharmaceutical
Ingredients)" of 28 March 2025
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3
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Date
of Publication
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29 March 2025
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4
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Date
of entry into force
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29 March 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/352-2025-%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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State Service of Ukraine on Medicines and Drugs Control
Address: 120-A Beresteiska
Avenue, Kyiv 03115
Website: https://www.dls.gov.ua
Telephone: +380 (44)
422-55-77
Email: dls@dls.gov.ua
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12
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Contact
point for information on eligibility
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State Service of Ukraine on Medicines and Drugs Control
Address: 120-A Beresteiska
Avenue, Kyiv 03115
Website: https://www.dls.gov.ua
Telephone: +380 (44)
422-55-77
Email: dls@dls.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
has been adopted to align the Licensing Conditions for Conducting Business
Activities for the Production of Medicines, Wholesale and Retail Trade in
Medicines, and Import of Medicines (except for Active Pharmaceutical
Ingredients)" (hereinafter - the Licensing Conditions) with 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), specifically stipulates that parallel import
of medicines shall be carried out by a business entity — a parallel importer
— holding both a license for the import of medicines in accordance with the
Licensing Conditions and a permit for parallel import of medicines.
The amendments to
the Licensing Conditions, approved by the Resolution of the Cabinet of
Ministers of Ukraine No. 352 of 28 March 2025 include, in particular:
·_
the introduction of definitions for
"parallel importer" and "parallel import of medicines";
·_
a clarification that parallel import of
medicines is carried out by parallel importers holding a license for
conducting business activities related to the import of medicines (excluding
active pharmaceutical ingredients), and a permit for parallel import,
obtained in accordance with the procedure established by law;
·_
the addition of a new section
"Requirements for parallel import" to the License Conditions.
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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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