BILLEV PHARMA EAST

NEWS

Ukraine’s Regulatory Reforms from May 2024

16 May 2024

Ukraine’s Regulatory Reforms from May 2024

Abolition of GMP Simplifications

Effective from April 17, 2024, Ukraine has abolished the temporary simplifications regarding the validity of GMP certificates that were in place during the martial law period. This resolution mandates that all imported medicinal products must now provide a GMP compliance conclusion from the State Service of Ukraine on Medicines and Drug Control (SSUMDC).

 

Implementation of eCTD

Ukraine has begun the gradual implementation of the electronic Common Technical Document (eCTD) format for submitting dossiers related to medicinal products. The full mandatory transition is scheduled for August 18th, 2025, allowing stakeholders ample time to adapt to the new requirements. A test period for submitting dossiers for new registrations started in May 2024, and for re-registrations and amendments in July, which will last until the end of December 2024.

Order No. 691 of the Ministry of Health (MOH) dated April 23, 2024, approved the requirements for the Specification of the electronic Common Technical Document (eCTD) format, including requirements for Module 1 and validation criteria. Documents in Module 1 must be signed with a qualified electronic signature (QES) by the representative of the MAH. The requirements for Modules 2–5 of the eCTD format comply with the general ICH requirements.

 

New Law on Medical Cannabis

New law on the Regulation of the Circulation of Medicinal Products Based on Cannabis will be implemented on 16 August 2024. The law aims to implement best practices in regulating importation and circulation of cannabis products and its derivates to prevent misuse. Currently, amendments to related regulatory acts are being developed.

 

Pharmacovigilance audits

The State Expert Center of the MOH of Ukraine will continue to conduct scheduled and targeted audits of MAH and their pharmacovigilance system. Targeted audits are usually due to significant changes in the pharmacovigilance system, untimely safety updates and reports, or poor-quality documents. A new pharmacovigilance procedure, which brings significant changes to the existing regulation, is currently under public discussion.

 

Expert evaluation of the quality summary addendum

As part of the ongoing alignment with EU legislation, from September 1st, 2023, an expert evaluation of the quality summary addendum will be required during the re-registration of medicinal products.