Obligations of persons responsible for wholesale distribution
Article 8
Open ↗1. The persons responsible for wholesale distribution referred to in Article 101(3) of Regulation (EU) 2019/6 (‘the responsible persons’) shall ensure compliance with good distribution practice for veterinary medicinal products. In addition to the requirement laid down in Article 100(2)(a) of that Regulation, the responsible persons shall have appropriate competence and experience as well as knowledge of, and training in, compliance with good distribution practice for veterinary medicinal products. 2. The responsible persons shall be personally responsible for fulfilling their obligations and shall be contactable at any time. 3. The responsible persons may delegate their tasks but not their responsibilities. 4. If the responsible persons are not available, the persons referred to in Article 1(2) shall appoint a substitute for the necessary time period so that continuity of business is ensured. 5. A written job description of the responsible persons shall define their authority to take decisions with regard to their responsibilities. The persons referred to in Article 1(2) shall give the responsible persons the defined authority, resources and responsibility needed to fulfil their duties. 6. The responsible persons shall carry out their tasks in such a way as to ensure that the relevant persons referred to in Article 1(2) can demonstrate compliance with good distribution practice for veterinary medicinal products and that the obligations referred to in Article 101(4) of Regulation (EU) 2019/6 are met. 7. The obligations of the responsible persons shall include: (a) ensuring that a quality system is implemented and maintained; (b) focusing on the management of authorised activities and the accuracy and quality of records; (c) ensuring that initial and continuous training programmes are implemented and maintained; (d) coordinating and promptly performing any recall operations for veterinary medicinal products; (e) ensuring that relevant customer complaints are dealt with effectively; (f) ensuring that suppliers and customers are approved; (g) approving any subcontracted activities which may impact on good distribution practice for veterinary medicinal products; (h) ensuring that self-inspections are performed at appropriate regular intervals following a prearranged programme and ensuring that the necessary CAPA are put in place; (i) keeping appropriate records of any delegated tasks; (j) deciding on the final disposition of returned, rejected, recalled or falsified veterinary medicinal products; (k) approving any returns to saleable stock; (l) ensuring that any additional requirements imposed on certain veterinary medicinal products by national law are adhered to; (m) documenting deviations and deciding on CAPA to correct deviations and avoid their reoccurrence and monitoring of the effectiveness of those CAPA.