Veterinary Wholesale Distribution Authorisation (WDA)

Veterinary Wholesale Distribution Authorisation (WDA)

Jul 23, 2026 | Acorn Regulatory News, Veterinary

Commission Implementing Regulation (EU) 2025/2091 of 17 October 2025 laying down good manufacturing practice for veterinary medicinal products in accordance with Regulation (EU) 2019/6 of the European Parliament and of the Council.

The end of the post-Brexit “grace period” on December 31, 2025 significantly impacts how VMP’s move between the EU and the UK

In 2026, cross-border distribution of veterinary medicinal products is governed by Regulation (EU) 2019/6 (January 28, 2019), with critical changes taking effect for the United Kingdom and Northern Ireland on January 1, 2026.

New Manufacturing Regulation (EU) 2025/2091 takes effect on July 16, 2026 introducing new Good Manufacturing Practice (GMP) requirements specifically for VMPs.

  • As of Jan 1, 2026 VMP’s distributed in Northern Ireland (NI) must comply with the full EU rules to maintain access to the single market.
  • Products entering NI from Great Britian (GB) must now be re-batch tested and have a Marketing Authorisation (MAH) registered within the EU.
  • Products must be released by a QP based in the EU or NI for NI Market.
  • Products placed on the NI market before December 31, 2025 can remain on the market until their expiry date without meeting 2026 requirements.
  • Wholesalers in NI can only source authorised VMP’s from suppliers established in NI or EU Member states, effectively barring direct sourcing from GB unless through specific schemes as follows:
    • Veterinary Medicines Internal Market Scheme: Allows NI vets to procure specific medicines from GB that are not authorised or available in NI, without requiring a special import certificate for each animal.
    • Veterinary Medicines Health Situation Scheme: Permits the emergency use of alternative products from outside NI if a public or animal health crises arises due to supply shortages.
Veterinary Wholesale Distribution Authorisation (WDA) - EU Directives

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