|
1
|
Notifying Member
|
Ukraine
|
|
2
|
Title of new
legislation/procedure
|
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
|
|
3
|
Date of Publication
|
15 April 2025
|
|
4
|
Date of entry into force
|
15 April 2025
|
|
5
|
Website link/Official
publication of the new regulation/procedure
|
https://zakon.rada.gov.ua/laws/show/z0439-25#Text
|
|
6
|
Have you attached a copy of the
regulation (PDF) to the Secretariat
|
[] Yes. (Please attach a copy of the regulation to the notification.)
[X] No.
|
|
7
|
Type of notification
|
[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)
|
|
8
|
List of products subject to
licensing
|
30 (HS-22) Pharmaceutical Products
|
|
9
|
Nature of licensing
|
Automatic: []
Non-Automatic: [X]
|
|
10
|
Administrative purpose/measure
being implemented
|
(a)
|
|
Protect public morals;
|
|
(b)
|
|
Protect human, animal or plant life and health;
protect environment;
|
|
(c)
|
|
Collect trade statistics or market surveillance;
|
|
(d)
|
|
Protection of patents, trademarks and copyrights, and
the prevention of deceptive practices;
|
|
(e)
|
|
Pursue obligations under the UN Charter and other
international treaties (i.e. CITES, Basel
Convention, Rotterdam Convention, UNSC Resolutions etc.)
|
|
(f)
|
|
Quota (including TRQ) administration;
|
|
(g)
|
|
Regulate imports of arms, ammunition or fissionable
materials and safeguard national security;
|
|
(h)
|
|
Other: ______________ (please specify)
|
|
11
|
Administrative body(ies) for submission
of applications
|
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
|
|
12
|
Contact point for information
on eligibility
|
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
|
|
13
|
Expected duration of licensing
procedure
|
Ongoing
|
|
14
|
A
summary of the notification in one of the WTO official languages
|
To ensure public access to quality and
affordable medicines that have been authorized and placed on the market for
use in the Member States of the European Union or the European Free Trade
Association, which is a party to the Agreement on the European Economic Area,
the Ministry of Health of Ukraine approved by the Order No. 277 of 17 February
2025 the Procedure for issuing, amending, suspending, cancelling and
terminating a permit for parallel import of a medicine pursuant to the
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.
This Procedure sets out the rules for
issuing or refusing to issue permits for
parallel import of medicines, as well as for amending, suspending,
renewing, cancelling and terminating the validity of such permits by the
State Service of Ukraine on Medicines and Drugs Control.
The Procedure includes three Annexes:
- Annex 1: Application for a Permit for
the Parallel Import of Medicines;
- Annex 2: Application for Amendments to
the Dossier of a Medicine for which a Permit for Parallel Import of Medicines
was Issued:
- Annex 3: Conclusion on the Review of the Dossier of
Materials of a Medicine for Parallel Import or Amendments Thereto.
|
|
15
|
In
the case of 7(b), please indicate the type of new change(s)
|
|
(a)
|
|
Termination
|
|
(b)
|
|
Suspension
|
|
(c)
|
|
Modification of specific
details in existing
procedures:
|
|
|
Product coverage;
|
|
|
Administrative
purpose;
|
|
|
Automatic or
Non-automatic;
|
|
|
Duration of
licensing;
|
|
|
Change the nature of
quantity/value restriction;
|
|
|
Eligibility of
applicants;
|
|
|
Contact information
on eligibility;
|
|
|
Administrative
body(ies) for submission of application;
|
|
|
Documentation
requirements (including application form);
|
|
|
Period for
Application;
|
|
|
Administrative
body(ies) to issue licence;
|
|
|
Processing time for
issuing licence;
|
|
|
Licence
fee/administrative charge;
|
|
|
Deposit/advance
payment and relevant conditions;
|
|
|
Appeal
regulations/procedures;
|
|
|
Validity of licence;
|
|
|
Other conditions of
licence (extension, transferability, penalty of non-use etc.);
|
|
|
Foreign exchange
requirements;
|
|
|
Other:
|
|
|
|
|
|
|
16
|
Please
elaborate the changes in detail (in one of the WTO official languages)
|
|