Legislation (in English)

06.05.2021 Updated 01.05.2026 134158 views

Attention!

This section presents unofficial translations for informational purposes. Copying is permitted only with a hyperlink to the source – dec.gov.ua

Attention!

Translations are provided for information purposes only and have no legal force. Copying is allowed only with a hyperlink to the source – dec.gov.ua.

LAW OF UKRAINE On Medicinal Products, 2022 (as amended) / LAW OF UKRAINE “On Medicines”, 2022 (as amended)DOCX · 295 KB · 01.05.2026

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LAW OF UKRAINE On Medicinal Products, 1996 (as amended) / LAW OF UKRAINE “On Medicines”, 1996 (as amended)DOC · 358 KB · 13.06.2022

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Resolution of the Cabinet of Ministers of Ukraine of May 26, 2005 No. 376 / Decree of the Cabinet of Ministers of Ukraine of May 26, 2005 № 376“On Approval of the Procedure for State Registration (Re-registration) of Medicinal Products and Amounts of Fees for Their State Registration (Re-registration)”
«On Approval of the Procedure for State Registration (Re-registration) of Medicinal Products and Amounts of Fees for Their State Registration (Re-Registration)»DOCX · 69 KB · 23.05.2022

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Resolution of the Cabinet of Ministers of Ukraine of December 29, 2021, No. 1446 Certain issues of state registration of medicinal products, vaccines or other medical immunobiological preparations for the treatment and/or specific prevention of acute respiratory disease COVID-19 caused by the SARS-CoV-2 coronavirus, subject to an obligation, for emergency medical use

Decree of the Cabinet of Ministers of Ukraine of December 29, 2021 № 1446 Some issues of state registration of medicinal products, vaccines or other medical immunobiological products for treatment and/or specific prevention of acute respiratory disease COVID-19 caused by coronavirus SARS-CoV-2 subject to obligations for emergency medical use

MoH ORDER OF UKRAINE 26.08.2005 No. 426 (as amended) On Approval of the Procedure for Conducting Expert Evaluation of Registration Materials for Medicinal Products Submitted for State Registration (Re-registration), and Expert Evaluation of Materials on Amendments to the Registration Materials during the Validity of the Registration Certificate

Procedure for Conducting Expert Evaluation of Registration Materials Pertinent to Medicinal Products, which are Submitted for State Registration (Re-Registration) and Expert Evaluation of Materials about Introduction of Changes to the Registration Materials during the Validity Period of Registration Certificate approved by the MoH Ukraine Order of 26.08.2005 № 426, registered at the Ministry of Justice of Ukraine on September 19, 2005 under N 1069/11349 (as amended)

MoH ORDER OF UKRAINE 23.09.2009 No. 690 (as amended) On Approval of the Procedure for Conducting Clinical Trials of Medicinal Products and Expert Evaluation of Clinical Trial Materials and the Model Regulations on Ethics Committees

Procedure for Conducting Clinical Trials of Medicinal Products and Expert Evaluation of Materials Pertinent to Clinical Trials and Model Regulations of the Ethics Committees approved by the MoH Ukraine Order of 23.09.2009 № 690, registered at the Ministry of Justice of Ukraine on 29.10.2009 under № 1010/17026 (as amended)

ORDER OF THE MINISTRY OF HEALTH OF UKRAINE 27.12.2006 No. 898 (as amended) On approval of the Procedure for pharmacovigilance

Pharmacovigilance Procedure approved by the MoH Ukraine Order of 27.12.2006 № 898 (in wording of the MoH Ukraine Order of 26.09.2016 № 996), registered at the Ministry of Justice of Ukraine on 19.12.2016 under № 1649/29779

MoH OF UKRAINE ORDER 17.11.2016 No. 1245 (as amended) On approval of the Procedure for review of registration materials for medicinal products submitted for state registration (re-registration), and of materials on amendments to registration materials during the validity of the registration certificate for medicinal products registered by the competent authorities of the United States of America, the Swiss Confederation, Japan, Australia, Canada, and medicinal products registered under the centralized procedure by the competent authority of the European Union

Procedure for Review of Registration Materials Pertinent to Medicinal Products Submitted for the State Registration (Re-Registration) and Materials about Introduction of Changes to Registration Materials during the Validity Period of Registration Certificate for Medicinal Products Registered by Competent Authorities of the United States of America, the Swiss Confederation, Japan, Australia, Canada and Medicinal Products Registered by Competent Authority of the European Union Through Centralized Procedure
approved by the MoH Ukraine Order of 17.11.2016 № 1245, registered at the Ministry of Justice of Ukraine on December 14, 2016 under № 1619/29749 (as amended)