European GMP System and Its Implementation in Ukraine

2026 became an important year for the regulation of veterinary medicinal products in the EU. From July 16, a separate GMP regulatory framework began to apply to veterinary medicinal products and active substances.

However, this does not mean that the EU has effectively created an entirely new system from scratch. The fundamental principles of GMP remain unchanged. The new system adapts them to the specific features of modern regulation of veterinary medicinal products. At the same time, the European Commission emphasises that the requirements for veterinary medicinal products remain aligned with GMP requirements for medicinal products for human use.

This experience is particularly important for Ukraine, as we are currently going through our own transition towards a fully functioning GMP system in the veterinary sector.

Ukraine is not starting this process from scratch. Good Manufacturing Practice rules for veterinary medicinal products have been in force since 2018. However, the new legislation governing veterinary medicinal products provides for a much broader application of GMP principles.

This is no longer simply about individual manufacturing requirements, but about integrating GMP into the entire system for regulating veterinary medicinal products. This process is still ongoing. A secondary regulatory framework is currently being developed to detail Good Manufacturing Practice requirements and the procedure for their practical application.

For businesses, this means that preparing only for a future inspection will not be enough. GMP must become part of an enterprise’s day-to-day operations — from the organisation of manufacturing and quality control to process documentation and batch release.

The Qualified Person plays a particularly important role in this system. Under the European model, the Qualified Person is responsible for certifying that each batch has been manufactured and controlled in accordance with the established requirements before it is placed on the market.

And the changes will affect not only manufacturers. Importers and marketing authorisation holders will also need to carefully review their manufacturing and logistics chains, the status of manufacturing sites, the allocation of responsibilities between the parties involved, documentation and batch release procedures.

In other words, this is about preparing the entire market, not just individual companies.

There is another important aspect. The new rules will work only if the state has sufficient capacity to apply them.

For businesses, this means a need for clear secondary legislation, understandable transitional mechanisms, predictable inspection procedures and sufficient time to adapt.

For the state, it means the need to build a team of competent GMP inspectors.

Such inspections require far more than knowledge of a regulatory document. An inspector must understand the pharmaceutical quality system, manufacturing and technological processes, risk management, qualification and validation. In the veterinary sector, it is also important to understand the specific features of manufacturing biological and immunological products.

Therefore, alongside the development of the regulatory framework, Ukraine needs to invest in the training and continuous professional development of GMP inspectors.

This will determine not only the quality of the inspections themselves. The consistency of approaches and the competence of inspectors will largely shape business confidence in the new system and, later, the confidence of European partners in the results of Ukrainian GMP control.

This is where a practical question arises, particularly relevant to imported veterinary medicinal products.

A significant share of such products is manufactured at sites in the European Union. These companies already operate in accordance with the European GMP system and are supervised by the competent authorities of EU Member States. Ukraine undoubtedly needs its own capable GMP system. In the long term, this should create a basis for the mutual recognition of inspection results.

However, at a stage when Ukraine’s own system is still being established, it is worth asking a practical question: does it make sense to automatically repeat inspections that have already been carried out by a competent EU regulator?

In our view, a logical solution would be to provide for the possibility of recognising the results of GMP control carried out by the competent authorities of EU Member States, while retaining the Ukrainian regulator’s right to conduct additional control where there is a justified risk.

Such an approach would avoid duplicating inspections that have already been conducted and using limited regulatory resources for this purpose. Instead, these resources could be directed towards what is far more important for Ukraine today: building its own institutional and expert capacity.

There is also a broader context. Ukraine is gradually aligning its regulatory framework with that of the EU — adopting EU requirements, standards and practices.

Therefore, recognising the results of controls conducted within the system we are integrating into appears to be a logical continuation of this process.