Ukraine moves to implement National Medicines Verification System

Corrected on 11 March 2026

Ukraine is gradually implementing a National Medicines Verification System (NMVS) to counter falsified medicines, enhance traceability in the supply chain, and align its regulations with EU standards.

Included in the new Law on Medicinal Products, manufacturers must apply safety features to medicines’ packaging according to the following deadlines:

• On a voluntary basis: from 1 January 2026, once the NMVS and the national repository go into operation;
• On a mandatory basis: from 1 January 2028.

Medicines placed on the market before 1 January 2028 without safety features may continue to be marketed in Ukraine until the expiry date.

The following article outlines the key regulatory requirements governing the NMVS and the status of its implementation in Ukraine, including the steps that manufacturers of medicines will be required to take.

Establishment of the NMVS

Ukraine’s regulatory initiatives are aligned with the EU Falsified Medicines Directive 2011/62/EU and Commission Delegated Regulation (EU) 2016/161, which introduced mandatory safety features on medicinal product packaging in the EU that went into effect in 2019.

In September 2024, the Cabinet of Ministers of Ukraine adopted Resolution No. 1121 establishing the regulatory framework for the NMVS. This framework includes:

• Creation and operation of a centralised data repository;
• Procedures for verification, deactivation, and reactivation of unique identifiers;
• Requirements for application of safety features to medicinal product packaging.

Designed in accordance with EU legislation and the principles of the European Medicines Verification System (EMVS), the Ukrainian verification system must ensure technical compatibility and full traceability across the supply chain (i.e. manufacturer to distributor to pharmacy/hospital).

Although the Ukrainian NMVS will operate independently, the EMVO has agreed to provide guidance and expert support to the Ukrainian NMVO. As a result, the system is expected to remain compatible with the EMVS, facilitating swift integration into the European framework following Ukraine’s anticipated EU accession.

Another important aspect is the development of a model for financing the NMVS. Manufacturers will use the national data repository on a paid basis, while pharmacies and distributors will have free access. The authorised governmental agencies will receive data for performing control and supervision functions.

Contributions from manufacturers are expected to cover the operation of the NMVS, the financing of the staff of the National Medicines Verification Organisation (NMVO), and contributions to the European Medicines Verification Organisation (EMVO).

Implementation of the NMVS will require close coordination with the EMVO-validated IT provider, and the development of internal IT solutions by manufacturers. At this stage, critical steps will include testing the developed IT solutions, connecting the state supervisory authority to the NMVS, and conducting training for users.

The NMVS will also need to be integrated with national health-care IT systems, including e-Stock and the Electronic Healthcare System (e-Health).

National Medicines Verification Organisation

The National Medicines Verification Organisation (NMVO) was founded in September 2025 by associations representing domestic and international manufacturers and marketing authorisation holders (MAHs), including:

• Association of Pharmaceutical Research and Development (APRaD);
• Association of International Pharmaceutical Manufacturers (AIPM Ukraine);
• Association of Organisations for Medical and Microbiological Employers of Ukraine;
• Association of Manufacturers of Medicines of Ukraine (AMMU);
• Indian Pharmaceutical Manufacturers Association (IPMA).

The NMVO will be responsible for creating and maintaining the national data repository. It will also ensure user access to the repository and provide information to market surveillance authorities, including the State Service of Ukraine on Medicines and Drugs Control (SMDC), which is expected to be replaced on 1 January 2027 by a new independent authority that will oversee the registration and market supervision of medicines, medical devices, cosmetics, and dietary supplements.

To access the NMVS, manufacturers and MAHs will need to do one of the following:

• join a founding association;
• create their own association; or
• enter into a paid agreement with the NMVO and use its services on contractual terms.

Key priorities of the NMVO include engaging a technical provider and initiating the system’s technical rollout.

Products subject to verification requirements

On 17 November 2025, the Ministry of Health implemented Order No. 1734 approving the lists of medicinal products subject to, or exempt from, safety-feature requirements. The Order is aligned with EU Regulation (EU) 2016/161 and includes the following provisions:

• Most prescription medicines will require safety features. Exceptions apply for certain categories (e.g. homeopathic products, cell therapy medicines, radiopharmaceuticals, reagents, precursors, medical gases, solutions, and anti-allergic products).
• Among non-prescription medicines, only omeprazole is currently expected to fall under the new verification requirements.
• Manufacturers may voluntarily apply safety features to any medicinal product and upload the relevant data to the NMVS.

Ministry Order No. 1734 took effect on 1 January 2026.

Safety feature requirements

Each medicinal product subject to verification must bear two safety features:

Unique Identifier — a two-dimensional barcode (GS1 DataMatrix) that contains:

• product code;
• serial number;
• batch lot number;
•  expiry date.

The code must comply with international coding standards (ISO/IEC), appear in black and white on a non-glossy surface and remain legible throughout the product’s shelf life. For user convenience, the product code and serial number must also appear in human-readable format next to the barcode.

Tamper-evident device — an anti-tampering mechanism (e.g. seal, perforated label, or adhesive tape) allowing verification that the package has not been opened. It must comply with ISO packaging standards, be impossible to remove without visible damage, and not obscure any information on the package or the 2D code.

Where medicines are supplied in grouped packaging, an aggregated code must be applied to the outer packaging, enabling simultaneous verification of all individual packs without opening the box.

Before placing a product on the market, the manufacturer must upload the following information to the centralised data repository and activate the unique identifiers:

• data elements of the 2D code;
• coding scheme;
• name and address of the manufacturer;
• a list of wholesalers purchasing, storing, and distributing the product.

All records on the operations with unique identifiers must be stored for at least five years from the date of manufacture or one year after the product’s expiry date, whichever is later.

Data stored in the national repository is confidential and accessible only to the party that uploaded it and, upon request, to the controlling authorities.

Implications for the pharmaceutical sector

Manufacturers and MAHs should already consider adjusting their production and labelling processes. They will be required to:

• implement technical capacity to apply safety features on packaging (i.e. generate and print 2D codes and apply tamper-evident devices);
• conclude agreements with the NMVO or be a member of a founding NMVO association to gain access to the national data repository;
• upload information to the repository and activate identifiers before placing products on the market.

Creating the National Medicines Verification System represents a major step for Ukraine’s integration into Europe. The NMVS will enhance market surveillance, ensure product authenticity, and strengthen patient safety. Market participants are strongly advised to use the voluntary period to align their production with the upcoming requirements.

For more information on the NMVS and Ukraine’s pharmaceutical sector, contact your CMS client partner or the CMS experts: Borys Danevych.