Ukraine Tightens Medicines and Reference Standards Import Controls

Ukraine has strengthened compliance requirements for medicines, reference standards, and reagents through updated procedures for Good Manufacturing Practice and importation of unregistered products.

Compliance Requirements for Medicines, Reference Standards, and Reagents in Ukraine

Ukraine has strengthened compliance requirements for medicines, reference standards, and reagents by updating Good Manufacturing Practice (GMP) procedures and the importation of unregistered products. The key changes include expanded recognition of regulatory authorities, streamlined timelines for procurement-related GMP confirmations, and explicit inclusion of the United Kingdom in the list of countries with strict regulatory systems.

1. Legal Framework and Key Regulations

The updated requirements are governed by the following regulations:

| Draft Order No. 706 (23 April 2025)¹ | Introduces amendments to Order No. 1130 and Order No. 237, including:

• Addition of the UK to the list of recognized regulatory authorities.
• Expedited GMP confirmation timelines for medicines procured by authorized healthcare entities.
• Clarification of requirements for unregistered medicines. | 28 April 2025 (general provisions); upon termination of martial law (clause 2 of Order No. 706)¹ | MoH |

2. Key Compliance Requirements

A. Good Manufacturing Practice (GMP) Compliance

1. Scope of GMP Confirmation
   • Applies to all manufacturers of medicines, including contract manufacturing facilities and intermediate manufacturing sites involved in the production of finished medicinal products³.
   • GMP compliance must be confirmed for:
   • Medicines registered in Ukraine.
   • Unregistered medicines procured by authorized healthcare entities, provided they are registered by a competent authority in:
   • The United States, United Kingdom, Swiss Confederation, Japan, Australia, Canada, or EU Member States (including those registered under the EU centralized procedure)^{1, 3}.

1. GMP Confirmation Process
   • Application Submission:
   • The Applicant (or their representative) must submit an Application for Certificate or Application for Conclusion to the State Service of Ukraine on Medicines and Drugs Control (SMDC), along with documents specified in Clause 2 of Section II of Order No. 1130³.
   • Timelines:
   • For unregistered medicines procured by authorized healthcare entities:
   • Document inspection: 5 working days³.
   • On-site inspection (if required): 40 calendar days (excluding time for applicant corrections)³.
   • Inspection report: 5 working days from completion of inspection³.
   • Overall GMP confirmation: No more than 5 working days after registration of the application (for medicines meeting the recognized regulatory authority criteria)³.
   • For other medicines: Timelines remain as specified in the original Order No. 1130 (not amended by the draft).

1. Procurement-Specific Requirements
   • Medicines procured by authorized healthcare entities (e.g., for public health programs) that are unregistered in Ukraine but registered by a recognized regulatory authority must comply with Ukrainian GMP requirements³.
   • All intermediate manufacturing facilities (including contract manufacturers) must be disclosed in the GMP confirmation application³.

B. Importation of Unregistered Medicines, Reference Standards, and Reagents

1. Eligibility for Importation
   • Unregistered medicines, reference standards, and reagents may be imported if they are registered by a competent authority in:
   • The United States, United Kingdom, Swiss Confederation, Japan, Australia, or Canada^{1, 2}.
   • The Draft Order No. 706 expands this list to explicitly include the UK, reflecting its continued high regulatory standards post-Brexit¹.

1. Procedure for Importation
   • Governed by Order No. 237 (as amended by Draft Order No. 706).
   • Specific requirements for documentation, labeling, and customs clearance are outlined in Order No. 237, but the draft amendments do not introduce substantive changes beyond the inclusion of the UK^{1, 2}.

C. Recognized Regulatory Authorities

The following countries are recognized for GMP compliance and importation purposes:

3. Enforcement and Timelines

1. Effective Dates
   • General Provisions of Draft Order No. 706: 28 April 2025 (or upon official publication, whichever is later)¹.
   • Clause 2 of Draft Order No. 706 (specific amendments to importation procedures): Upon termination or cancellation of martial law in Ukraine¹.

1. Responsible Authorities
   • Ministry of Health of Ukraine (MoH): Oversight of regulatory updates and enforcement^{1, 2, 3}.
   • State Service of Ukraine on Medicines and Drugs Control (SMDC): Handles GMP confirmation applications and inspections³.
   • Pharmaceutical Department of MoH: Ensures state registration and publication of orders^{1, 3}.

1. Compliance Monitoring
   • The Deputy Minister of Health is responsible for overseeing the implementation of Draft Order No. 706¹.
   • The First Deputy Minister of Health is responsible for overseeing the implementation of amendments to Order No. 1130³.

4. Summary Answer

Ukraine has strengthened compliance requirements for medicines, reference standards, and reagents through Draft Order No. 706 (23 April 2025), which amends Order No. 1130 (GMP compliance) and Order No. 237 (importation of unregistered products). Key changes include:

1. Expansion of Recognized Regulatory Authorities: The United Kingdom and EU Member States (including centralized EU registrations) are now explicitly included in the list of countries with strict regulatory systems for GMP compliance and importation purposes^{1, 3}.
2. Expedited GMP Confirmation for Procured Medicines: Unregistered medicines procured by authorized healthcare entities and registered by a recognized authority must comply with Ukrainian GMP requirements, with streamlined timelines (e.g., 5 working days for document inspection, 40 calendar days for on-site inspections)³.
3. Clarification of Procurement Requirements: All intermediate manufacturing facilities must be disclosed in GMP confirmation applications, and the process for confirming compliance has been standardized for unregistered medicines³.
4. Effective Dates: The amendments enter into force on 28 April 2025, except for importation-related changes, which take effect upon the termination of martial law¹.

These updates align Ukraine’s regulatory framework with international standards while ensuring timely access to critical medicines, particularly for public health procurement^{1, 2, 3}.

Sources

1. ↩ Draft Order of the Ministry of Health of Ukraine “On Amendments to the Procedure for Confirmation of Compliance of Manufacturing Conditions of Medicines with the Requirements of Good Manufacturing Practice and the Procedure for Importation of Unregistered Medicines, Reference Standards, Reagents into the Territory of Ukraine” https://members.wto.org/crnattachments/2025/TBT/UKR/final_measure/25_03972_00_e.pdf
2. ↩ Committee on Technical Barriers to Trade – Notification – Ukraine – Medicines https://docs.wto.org/dol2fe/Pages/SS/directdoc.aspx?filename=Q:/G/TBTN25/UKR335.pdf&Open=True
3. ↩ Draft Order of the Ministry of Health of Ukraine “On Approval of Amendments to the Procedure for Confirmation of Compliance of Manufacturing Conditions of Medicines with the Requirements of Good Manufacturing Practice” https://members.wto.org/crnattachments/2024/TBT/UKR/24_07161_00_e.pdf