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.

8.1 Obligations of contract giver

  1. The contract giver is responsible for any activities they have contracted out.
  2. The contract giver is responsible for assessing the competence of the contract acceptor to successfully carry out the work required and for ensuring by means of the contract and through audits that the principles of good distribution practice for veterinary medicinal products are followed.
  3. The contract giver must provide the contract acceptor with all the information necessary to carry out the contracted operations in accordance with the specific veterinary medicinal product requirements and any other relevant requirements.
  4. The contract giver must monitor and review the performance of the contract acceptor. The frequency of the audit must be defined based on risk, depending on the nature of the outsourced activities, and on the level of performance monitoring in place. The risk assessment must be documented and reviewed on an annual basis.
  5. The contract acceptor must permit the contract giver to audit the outsourced activities.

8.2 Obligations of contract acceptor

  1. The contract acceptor must have adequate premises, equipment, procedures, knowledge, and competent personnel to carry out the work ordered by the contract giver.
  2. The contract acceptor must not subcontract out any of the work under the contract to a third party without the contract giver’s approval of the arrangements. Arrangements made between the contract acceptor and any third party must also be in compliance with good distribution practice.
  3. The contract acceptor must refrain from any activity that may adversely affect the quality of the veterinary medicinal products handled, stored or transported for the contract giver.
  4. The contract acceptor must provide the contract giver with any information that may influence the quality, safety or efficacy of the veterinary medicinal products in accordance with the requirements of the contract.