Summary

The Veterinary Medicines Regulations require wholesale dealers in Great Britain to adhere to Good Distribution Practice for all distribution processes.

Any person acting as a wholesale dealer and supplying veterinary medicinal products must hold a valid Wholesale Dealer Authorisation (WDA) and must comply with Good Distribution Practice as set out in this document, in accordance with Schedule 3 of the Veterinary Medicines Regulations 2013 (as amended). The measures put in place should ensure that veterinary medicinal products are appropriately stored, transported and handled, and that they remain within the legal supply chain during storage and transport.

Contents

  • Principal

    Principles of good distribution practice for veterinary medicinal products.

  • Quality Management System

    A quality system is required to ensure that the objectives of good distribution practice are realised and should clearly set out responsibilities, processes and risk management principles in relation to the wholesale dealers’ activities.

  • Personnel Requirements

    There must be sufficiently competent personnel to carry out all the tasks for which the wholesale dealer is responsible.

  • Premises & Equipment

    Requirements for suitable and adequate premises and equipment to ensure proper storage and distribution of veterinary medicinal products.

  • Documentation, Procedures and Record-Keeping

    Requirements for documentation, procedures and record keeping.

  • Operations

    Operational requirements.

  • Complaints, Returns, Suspected Counterfeits and Recalls

    Requirements for handling complaints, returns, suspected counterfeits and recalls.

  • Outsourced Activities

    Good distribution practice for veterinary medicinal products must also be observed by third parties involved in the wholesale distribution of veterinary medicinal products and should be part of their contractual obligations.

  • Self-Inspections

    Requirements for a self-inspection programme.

  • Transport

    Requirements for transport of the veterinary medicinal products .

  • Annual Stock Audit

    Requirements for stock inventories which must be performed regularly.

  • Import Certificates

    Import certificates are required for non-UK licenced veterinary medicinal products which are to be placed on the UK market.

  • Pharmacovigilance

    Guidance on Pharmacovigilance reporting.

  • Supply Issues

    Notification to the VMD if they have a reason to suspect, or know of, a threat to the continued supply of a veterinary medicine.