Ukraine Pharma Regulatory Reform: New Medicinal Products Law Overview

On January 01, 2027, the new Law of Ukraine No. 2469-IX “On Medicinal Products”, adopted on July 28, 2022, will enter into force, with certain provisions becoming applicable from January 01, 2028. The Law establishes a fundamentally revised regulatory framework governing the registration and lifecycle management of medicinal products in Ukraine, bringing Ukrainian pharmaceutical legislation to the EU regulatory framework.

Key Changes

Among the most important reforms are:

- further harmonization of Ukrainian registration procedures with EU requirements;

- discontinuation of most simplified registration procedures;

- replacement of the current Instructions for Medical Use with the Summary of Product Characteristics (SmPC) and Package Leaflet (PL);

- introduction of updated labelling requirements;

- establishment of a new national medicines verification system;

- creation of the future Ukrainian Pharmaceutical Agency as the national Competent Authority;

- revised requirements for manufacturing, importation, wholesale distribution, pharmacovigilance and advertising of medicinal products.

Marketing Authorization Framework

The Law modernizes the Ukrainian registration procedure and introduces new documentation requirements.

Following registration, the Competent Authority will approve the SmPC, PL and other registration documents and prepare a public Assessment Report summarizing its scientific conclusions on the quality, safety and efficacy of the medicinal product.

The Law also introduces:

- updated rules for selecting reference medicinal products for generic applications;

- assessment of packaging mock-ups and, where required, Package Leaflet Readability User Testing;

- replacement of paper Registration Certificates with electronic records in the State Register of Medicinal Products.

Importation and Quality Control

The new Law introduces three separate regulatory regimes for the importation of medicinal products into Ukraine:

- Supply from EU/EFTA countries will be regulated as wholesale distribution activities.

- Parallel import will become possible under specified legal conditions;

- Import from third countries will remain subject to import licensing, batch certification and GMP requirements.

The Law also establishes the State Register of Medicinal Products Placed on the Market, which will contain information on medicinal product batches released in Ukraine, including the Importer and the Qualified Person responsible for batch release.

Another important change is the expansion of the responsibilities of the Importer's Qualified Person, who will decide whether a batch may be placed on the Ukrainian market based on document verification, visual inspection and, where required, state quality control. Consequently, information on the designated importer will also have to be included in the registration dossier.

In addition, the Law introduces a risk-based approach to state quality control. For medicinal products manufactured in SRAs countries, or where the batch has been tested by an Official Medicines Control Laboratory within the European network, additional state laboratory testing in Ukraine may not be required. Mandatory state quality control will apply only in cases specified by legislation, including suspected falsification, quality defects, or other circumstances requiring laboratory testing.

Other Important Changes

The Law also introduces several EU-based regulatory concepts, including:

- the sunset clause;

- updated marketing authorization renewal procedures;

- greater reliance on scientific assessments and regulatory decisions issued by EU Competent Authorities.

Transitional Period

MAHs will be required to bring their registration dossiers, product information and labelling into compliance with the new legislative requirements within five years from the Law's entry into force, unless otherwise provided by the transitional provisions.

Conclusion

The new Law represents the most significant reforms of the Ukrainian pharmaceutical regulatory framework in recent years. It introduces comprehensive changes affecting marketing authorization, pharmacovigilance, GMP recognition, labelling, packaging, importation and post-authorization obligations while bringing Ukrainian legislation substantially closer to the EU pharmaceutical framework.

MAHs are encouraged to assess the impact of the new requirements on their regulatory strategies and product portfolios well in advance of the applicable implementation deadlines.

For more detailed information regarding the implementation of the new legislation, documentation requirements and its potential impact on your products, please contact our Regulatory Affairs Department.