Abolishing of GMP simplifications, implementation of eCTD, registration of medical cannabis and other regulatory news

We inform you about key updates in the field of registration of medicines, quality control, and pharmacovigilance in Ukraine:

• Abolition of simplifications for GMP confirmation during the quality control of imported medicinal products; 
• Implementation of eCTD;
• Adoption of the Law on Medical Cannabis; 
• Scheduled and targeted audits of the Marketing Authorization Holder’s pharmacovigilance systems.
• Expert evaluation of the quality summary addendum during re-registration.

Abolition of simplifications for GMP confirmation

On April 17, 2024, the Resolution of the Cabinet of Ministers of Ukraine’s No. 1077 dd October 13, 2023, “On Amending Paragraph 31 of the Procedure for State Quality Control of Medicinal Products Imported into Ukraine,” came into effect. This resolution abolishes the simplifications regarding the confirmation (recognition) of GMP certificates in Ukraine during the period of martial law.

Accordingly, starting from April 17, when applying for a conclusion on the quality of imported medicinal products, a conclusion from the State Service of Ukraine on Medicines and Drug Control (SSUMDC) on the compliance of production with GMP requirements must be provided. As of April 17, 2024, the import of medicinal products without national confirmation of production compliance with GMP requirements is prohibited.

Please note that a batch of the medicinal product must be produced during the validity period of the GMP certificate that is recognized. For manufacturers undergoing inspection procedures, the batch must be produced during the validity of the certificate issued by the SSUMDC.

Implementation of eCTD

The gradual implementation of the eCTD format has started in Ukraine, with relevant changes to the state registration procedure approved in October 2023 and April 2024. 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, approves the requirements for the Specification of the electronic Common Technical Document (eCTD) format, including requirements for Module 1 and validation criteria. Order No. 733 of the MOH dated April 29, 2024, amends Order No. 691.

Documents in Module 1 must be signed with a qualified electronic signature (QES) by the representative of the Applicant (Marketing Authorization Holder) in Ukraine.

The requirements for Modules 2–5 of the eCTD format comply with the general ICH requirements.

During the transition to eCTD, a baseline submission is recommended to provide the regulatory authority with access to all or part of the previously submitted documentation within the eCTD lifecycle, consisting of the current registration materials for medicinal products in the eCTD format that were previously recommended for approval by the State Expert Center.

The mandatory transition to the eCTD format will occur on August 18, 2025, three years after the adoption of the Law of Ukraine “On Medicinal Products” in the 2022 edition.

Law on medical cannabis

On February 16, 2024, the Law on the Regulation of the Circulation of Medicinal Products Based on Cannabis came into effect, which will be implemented on August 16, 2024. The purpose of the Law is to implement best practices in regulating the limited circulation of cannabis, cannabis resin, extracts, and tinctures of cannabis, as well as tetrahydrocannabinol (THC), its isomers, and stereochemical variants. The Law introduces changes to Ukrainian legislation to create conditions for expanding patient access to necessary treatments and conducting scientific research.

From the effective date until January 1, 2028, a zero quota will be established for the importation of cannabis plants, narcotic drugs, psychotropic substances produced from cannabis plants, except for:

• Importation for use in scientific and technical activities;
• Importation of cannabis plant substances for the production of medicinal products and finished medicinal products included in the State Register of Medicinal Products;
• Importation of cannabis seeds and planting material.

Currently, amendments to related regulatory acts are being developed.

Pharmacovigilance

We remind you that the State Expert Center of the MOH of Ukraine conducts planned and targeted audits of the Applicant’s pharmacovigilance system. Reasons for a targeted audit may include significant changes in information about the pharmacovigilance system, untimely safety updates (updating instructions for medical use of medicinal products), untimely submission of adverse drug reaction reports, regularly updated safety reports, submission of poor-quality pharmacovigilance documents, etc.

A new pharmacovigilance procedure is currently under public discussion, which will significantly change the existing regulation. If adopted, we will inform you separately.

Expert evaluation of the quality summary addendum

To align legislation with the EU acquis, as of September 1, 2023, an expert evaluation of the quality summary addendum is required during the re-registration of a medicinal product. The addendum to the quality summary is an integral part of the re-registration dossier.

If you have any questions – feel free to contact us by e-mail info@cratia.ua, tel +380443324294 or schedule a meeting in our office.