Obligations of contract giver
Article 33
1. The contract giver shall be responsible for any activities contracted out. 2. The contract giver shall be 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. The contract giver shall perform an audit of the contract acceptor before commencement of the outsourced activities and shall monitor and review the performance of the contract acceptor. The frequency of audit shall be defined based on risk, depending on the nature of the outsourced activities. Where there has been a change to outsourced activities, the contract giver shall apply risk assessment as part of change control to determine if re-audit is required. The contract acceptor shall permit the contract giver to audit the outsourced activities. 3. The contract giver shall 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.