The European Union and the United States have completed the assessment of all EU Member States’ competent authorities under the pharmaceutical Good Manufacturing Practice (GMP) Mutual Recognition Agreement (MRA) for veterinary products. As of 29 May 2026, the agreement’s veterinary provisions are fully operational, enabling regulators to rely on each other’s GMP inspection results and removing the need for routine duplicate inspections of manufacturing sites covered by the agreement.

EU-US veterinary GMP mutual recognition: from scope extension to full implementation

Veterinary products were added to the EU–US MRA Sectoral Annex on Pharmaceutical GMP in May 2023 through Joint Sectoral Committee Decision No 2536/2023.

On 30 May 2023, the EU recognised the US Food and Drug Administration (FDA) as an equivalent authority for GMP inspections of veterinary products. At the same time, the FDA confirmed the equivalence of the inspection capabilities of 16 EU Member States.

The recognition process subsequently expanded to cover additional Member States. Between September 2023 and March 2025, the FDA recognised the competent authorities of Cyprus, Czechia, Germany, Italy, Latvia, Lithuania, Romania, Slovakia and Sweden, according to the European Commission.

On 29 May 2026, the FDA completed its assessments of the national competent authorities responsible for veterinary products in all EU Member States. The recognition process also covered the relevant authorities in Croatia and Malta, whose recognised inspection capabilities are subject to specific limitations. Following the resulting recognitions, the veterinary provisions of the Sectoral Annex became fully operational, and Article 9 became applicable.

How EU-US mutual recognition affects veterinary GMP inspection

The agreement allows the EU and the FDA to rely on GMP inspections conducted by recognised authorities in each other’s territories.

The recognition applies to routine GMP surveillance inspections within the recognised authorities’ assessed capabilities and the product scope of the agreement. Certain national authorities are subject to specific limitations regarding the types of products or inspections covered.

This reduces the need for duplicate inspections of manufacturing facilities supplying veterinary medicines to both markets. It also allows regulatory authorities to allocate inspection resources more efficiently, including by directing resources towards manufacturing sites in other countries and facilities presenting higher risks.

Mutual recognition does not eliminate the authorities’ inspection powers. The EU and US regulators retain the ability to conduct inspections when necessary.

EU-US MRA: changes to batch testing for US-veterinary medicines

A further practical consequence of the agreement’s full implementation concerns batch controls for veterinary medicines imported into the European Economic Area (EEA) from the United States.

From 29 May 2026, Qualified Persons (QPs) in EU Member States are relieved of the responsibility for repeating the controls specified in Article 97(7) of Regulation (EU) 2019/6, provided that the relevant conditions under the MRA are fulfilled.

The exemption applies when:

• the veterinary medicinal product was manufactured in the United States
• the required controls have been carried out in the United States
• each batch is accompanied by a certificate issued by the manufacturer, confirming compliance with the marketing authorisation requirements and signed by the person responsible for batch release

Importantly, the exemption concerns batch controls and testing, not batch certification and release. The requirement for certification by a Qualified Person in the EEA remains in place.

Products covered by the agreement EU-US GMP agreement

The veterinary provisions cover veterinary pharmaceuticals, including prescription and non-prescription medicines.

The scope also includes certain products used in the preparation of medicated feed:

• premixes for veterinary medicated feeds in the EU;
• Type A medicated articles in the United States.

Veterinary immunological products are excluded from the agreement’s scope.

These product-specific provisions are important for manufacturers and importers when determining whether individual products qualify for the mutual recognition arrangements.

GMP mutual recognition implications for manufacturers and regulators

The full implementation of the veterinary provisions strengthens regulatory cooperation between the EU and the United States.

For regulatory authorities, the ability to rely on recognised inspection results reduces duplication and supports more efficient allocation of GMP inspection resources.

For manufacturers operating across both markets, the arrangement can reduce inspection-related administrative burdens and eliminate repeat batch testing in eligible cases. This may also simplify certain aspects of the importation and quality-control process.

The European Commission identifies the changes as measures intended to reduce trade barriers and facilitate access to veterinary medicines while maintaining GMP oversight.

The completion of the recognition process on 29 May 2026 therefore represents an important milestone in transatlantic regulatory cooperation for veterinary medicines. It extends the fully operational framework already established for most human medicines in 2019 to the veterinary sector, while retaining the agreement’s product-specific exclusions and conditions.