On 30 July 2021, the Official Journal of the European Union published the Commission Implementing Regulation (EU) 2021/1248 of 29 of July 2021, as regards measures on good distribution practice for veterinary medicinal products in accordance with Regulation (EU) 2019/6 of the European Parliament and of the Council (“Implementing Regulation“). The Implementing Regulation applies to holders of manufacturing authorizations performing wholesale distribution of veterinary medicinal products covered by that manufacturing authorization, and to holders of a wholesale distribution authorization, including those established or operating under specific customs regimes, such as free zones or customs warehouses. This Implementing Regulation responds to the need for guidelines on good distribution practice in respect of veterinary medicinal products, in line with those already existing for medicinal products for human use.
Relevant sections of good distribution practice for veterinary medicinal products should also be adhered by third parties involved in the wholesale distribution of veterinary medicinal products and should be part of their contractual obligations. Therefore, the supply chain should be reviewed and the relevant agreements should be identified and updated to include the new obligations and responsibilities. Written agreements need to exist to cover any activity outsourced to a third party, establishing the obligations of each party.
A closer look
The Implementing Regulation introduces the following main obligations:
- Quality management. Those subjects under the scope of the Implementing Regulation shall develop a quality system, taking into account the size, structure and complexity of the activities performed, which shall cover the control and review of any outsourced activities related to the wholesale distribution of veterinary medicinal products. This quality system must be fully documented.
- Personnel requirements. The person responsible for the wholesale distribution must ensure compliance with good distribution practice and is personally responsible for fulfilling his/her obligations which include, among others: ensuring that the quality system is implemented and maintained; focusing on the management of authorized activities and the accuracy and quality of records; coordinating and promptly performing any recall operations for veterinary medicinal products; ensuring that relevant customers complaints are dealt with effectively; or ensuring that suppliers and customers are approved.
- Premises and equipment. The persons distributing veterinary medicinal products should have suitable premises, installations and equipment, in order to ensure proper storage and distribution of veterinary medicinal products. The Implementing Regulation foresees that premises shall be designed or adapted to maintain the required storage conditions, and factors such as temperature, light, humidity and cleanliness of the premises should be checked by means of suitable equipment and procedures.
- Documentation, procedures and record-keeping. Implementing Regulation sets that documentation must fulfil specific requirements (be readily available, written in a language understood by personnel, etc.) and must be approved, signed and dated by appropriate authorized persons, if required. On the other hand, procedures must describe the wholesale distribution activities affecting the quality of veterinary medicinal products and there is an obligation to keep records, either in the form of purchase or sales invoices, delivery slips, or in electronic form, for any transaction in veterinary medicinal products received or supplied.
- Operations. Requirements for operations, verification of eligibility and approval of suppliers and customers are also set in the implementing Regulation. In particular, the person responsible must ensure that the traceability of the veterinary medicinal product is not lost during the wholesale distribution and must use all means to minimise the risk of falsified veterinary medicinal products. Moreover, the Implementing Regulation develops other aspects such as the receipt of veterinary medicinal products, storage, destruction of obsolete veterinary medicinal products, supply and export.
- Complaints, returns, suspected falsified veterinary medicinal products and recalls. Complains must be recorded with all original details, distinguishing between complaints related to the quality of a veterinary medicinal product and those related to wholesale distribution. Returns must be conducted in accordance with national law and contractual arrangements between the parties, and returned veterinary medicinal products must be handled according to a written, risk-based process. However, for veterinary medicinal products that have left the care of the persons to whom the Implementing Regulation applies, must be returned to saleable stock only if they meet some specific conditions. Special attention is given to falsified veterinary medicinal products; their distribution must be immediately stopped and, if identified in the supply chain, immediately segregated.
- Outsourced activities. Among other provisions, the Implementing Regulation states that the contract giver shall be responsible for any activities contracted out, and the contract acceptor must have adequate equipment, procedures, knowledge and experience, competent personnel to carry out the work ordered by the contract giver and premises if required for the activity.
- Self-inspections. A self-inspection programme must be implemented, which will cover all aspects of good distribution practice for veterinary medicinal products and compliance with the Implemented Regulation and procedures within a defined time frame.
- Transport. Lastly, specific requirement for transports, containers, packaging and labelling are set. Those under the scope of the Implementing Regulation are responsible for protecting veterinary medicinal products against breakage, adulteration and theft, and for ensuring that temperature conditions are maintained within acceptable limits during transport, and, it possible, those conditions should be monitored. Likewise, veterinary medicinal products must be transported in containers that have no adverse effect on the quality of the veterinary medicinal product and that offer adequate protection from external influences.