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
- Notifying member
- Ukraine
- Title
- 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
- First published
- 15/04/2025
- First EIF
- 15/04/2025
- Latest published
- 15/04/2025
- In force to
- Latest notification
- G/LIC/N/2/UKR/33
- Product categories
- List of products subject to licensing
-
30PHARMACEUTICAL PRODUCTS
- Attachment
- Nature of licensing
-
Non-automatic
- Administrative purpose/measure being implemented
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- Protect human, animal or plant life and health; protect environment
- Administrative body(ies) for submission of applications
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- State Service of Ukraine on Medicines and Drugs Control
- 120-A Beresteiska Avenue, Kyiv 03115
- https://www.dls.gov.ua
- +380 (44) 422-55-77
- Contact point for information on eligibility
-
Same as the "Administrative bodies"
- Expected duration of licensing procedure
- Ongoing
- Found by secretariat
- No
- Links
-
- Related document symbols
-
- G/LIC/N/2/UKR/33
- Source
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https://zakon.rada.gov.ua/laws/show/z0439-25#Text
- Notes
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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, canceling 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.
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