A Veterinary Medicinal Product Wholesale Distribution Authorisation (VMP WDA) allows a company to legally distribute veterinary medicinal products (VMPs) within Ireland and across the European Union. Wholesale distribution includes activities such as purchasing, storing, supplying, or exporting these products.
The process involves adhering to strict regulatory standards, submitting a comprehensive application, and successfully passing an Inspection by the Department. These steps ensure that veterinary medicines are handled safely, protecting both animal health and public safety.
Regulatory Framework
The licensing system is based on EU legislation, particularly Regulation (EU) 2019/6, (REGULATION (EU) 2019/6 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 11 December 2018 on veterinary medicinal products and repealing Directive 2001/82/EC) which governs veterinary medicines across member states. In Ireland:
- The Health Products Regulatory Authority (HPRA) authorises veterinary medicines.
- The Department of Agriculture, Food and the Marine (DAFM) is responsible for licensing premises and wholesale distribution activities.
Key Requirements
Before applying, applicants must ensure they meet several essential criteria:
- Suitable premises: Facilities must be appropriate for the safe storage and handling of veterinary medicines.
- Responsible Person (RP): A suitably qualified individual must be appointed to oversee regulatory compliance.
- Good Distribution Practice (GDP) in adherence to Regulation on Good Distributional Practices (EU 2021/1248): Businesses must comply with EU GDP guidelines to maintain product quality and prevent counterfeit medicines from entering the supply chain.
Application Process
Applicants must complete the official WDA application form, available on the DAFM website (Gov.ie), under the Veterinary Medicines section. The application typically requires:
- Company and premises details.
- A description of activities (e.g., storage, export, procurement).
- Category / Type of products that will be procured, stored, and supplied.
- Details of the Responsible Person and Deputy Responsible Person.
- Information on quality systems and GDP compliance procedures.
Acorn Regulatory provide specialist regulatory consulting services to support wholesalers and distributors with Veterinary Medicinal Product WDA applications, GDP compliance, Responsible Person requirements and regulatory inspection preparedness.
Inspection by the Department of Agriculture, Food and the Marine
- On receipt of a valid application, the DAFM will inspect the premises to ensure compliance with legal and GDP requirements.
- Inspectors assess the premise, the proposed storage conditions, quality systems, and its operational procedures.
- Approval is granted only if all required standards are fully met.
Granting of the Veterinary WDA license
If the application is successful:
- A VMP WDA license is issued which is valid in Ireland and across the European Union.
- The authorisation is recorded in the EU database (EudraGMDP).
- The business must continue to comply with all regulatory requirements and may be subject to periodic inspections.
