Ukraine Tightens Medicines and Reagents Compliance Requirements

Ukraine has strengthened regulatory oversight of medicines, reference standards, and reagents through updated Good Manufacturing Practice procedures and import controls.

Regulation Analysis: Strengthened Oversight of Medicines, Reference Standards, and Reagents in Ukraine

Ukraine has recently updated its regulatory framework to enhance oversight of Good Manufacturing Practice (GMP) compliance for medicines and the importation of unregistered medicines, reference standards, and reagents. The key changes are introduced through two draft orders of the Ministry of Health of Ukraine (MoH), which amend existing procedures to align with international standards and expand the scope of recognized regulatory authorities.

Below is a structured breakdown of the requirements, recognized jurisdictions, and procedural updates under the new regulations.

1. Key Regulatory Updates

A. Amendments to GMP Compliance Confirmation Procedure

(Order No. 1130 of 27 December 2012, as amended by Draft Order No. 706 of 23 April 2025^{1, 2})

B. Amendments to Import Procedures for Unregistered Medicines, Reference Standards, and Reagents

(Order No. 237 of 26 April 2011, as amended by Draft Order No. 706 of 23 April 2025¹)

2. Detailed Procedural Requirements

A. Documentation for GMP Compliance Confirmation²

To obtain a GMP compliance certificate (Conclusion or Certificate) from the SMDC, applicants must submit:

1. For All Applicants:
   • A certified copy of the manufacturing license (with Ukrainian/English translation for non-residents)².
   • A certified printout from EudraGMP, FDA (USA), or other official databases (with Ukrainian translation) if the site is listed².
   • A Site Master File (SMF) (in Ukrainian/English) unless the manufacturer is located in the EU, UK, Switzerland, Japan, Australia, Canada, or an MRA country².

1. For Unregistered Medicines (or Those Under Registration):
   • A Certificate of a Pharmaceutical Product (CPP) issued by a recognized authority (EU/UK/Switzerland/Japan/Australia/Canada or MRA countries)².
   • A guarantee letter (per Annex 6 of the Procedure)².

1. For Plasma Collection/Storage Sites:
   • A Plasma Site Master File (in Ukrainian/English)².

1. For Contract Manufacturing:
   • Marketing authorization (MA) copies from EU/UK/Switzerland/Japan/Australia/Canada or MRA countries if any production stage occurs outside these jurisdictions².

B. Exemptions for Recognized Jurisdictions²

If all manufacturing stages occur in:

• EU member states,
• UK,
• Switzerland,
• Japan,
• Australia,
• Canada, or
• Countries with MRAs with the EU or Ukraine,

applicants only need to submit:

• A certified copy of the manufacturing license,
• A GMP compliance certificate from the relevant authority, and
• Certified Ukrainian translations of these documents².

3. Timeline and Enforcement¹

• Effective Date: The Order enters into force on 28 April 2025, except for provisions tied to the termination of martial law in Ukraine¹.
• Publication: The Order will be published on the MoH’s official website after state registration with the Ministry of Justice¹.
• Responsible Authority: The Pharmaceutical Department of the MoH oversees implementation, while SMDC handles inspections and compliance verification^{1, 2}.

4. Key Changes from Previous Regulations

1. Expanded Recognition of GMP Certificates:
   • The UK is now explicitly included in the list of recognized jurisdictions (previously omitted)¹.
2. Stricter Documentation for Unregistered Products:
   • Unregistered medicines now require a CPP from a recognized authority².
3. Electronic Database Verification:
   • Applicants must provide certified printouts from EudraGMP, FDA (USA), or other official databases with Ukrainian translations².
4. CAPA Plan Requirement:
   • If a manufacturing site has unresolved GMP violations, a corrective action plan must be submitted before a new application².

Summary Answer

Ukraine has strengthened regulatory oversight of medicines, reference standards, and reagents through Draft Order No. 706 of 23 April 2025, which amends the GMP compliance confirmation procedure and import controls for unregistered products^{1, 2}. Key changes include:

• Expanded recognition of GMP certificates from the UK, EU, Switzerland, Japan, Australia, Canada, and MRA countries¹.
• Mandatory submission of a Certificate of a Pharmaceutical Product (CPP) for unregistered medicines and electronic database printouts (e.g., EudraGMP, FDA) with Ukrainian translations².
• Exemptions for manufacturers in recognized jurisdictions (e.g., EU/UK), who only need to provide a manufacturing license and GMP certificate².
• Stricter requirements for unresolved GMP violations, including the submission of a corrective action plan (CAPA)².

The Order takes effect on 28 April 2025, with enforcement led by the State Service of Ukraine on Medicines and Drugs Control (SMDC)^{1, 2}.

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. ↩ 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_08412_00_x.pdf