Transport

Requirements for transport of the veterinary medicinal products .

10.1 Transport Requirements

  1. The wholesale dealer is 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 must have measures in place to monitor such conditions.
  2. Veterinary medicinal products must be transported in such a way that their identification is not lost, in packages that have no adverse effect on the quality or identification of the products and that offer adequate protection from external influences, including contamination.
  3. Packages must be labelled with sufficient information for safe storage and handling. They must enable identification of the contents and the source.
  4. If a deviation such as temperature excursion or veterinary medicinal product damage has occurred during transport, this must be reported to the WQP and to the consignee of the affected veterinary medicinal products. Assessments on the potential impact on the quality of the veterinary medicinal products concerned must be made and a procedure put in place for investigating and handling temperature excursions.
  5. The wholesale dealer must ensure that vehicles and equipment used to distribute, store or handle veterinary medicinal products are suitable for their use and appropriately equipped to prevent exposure of the veterinary medicinal products to conditions that could affect their quality and packaging integrity.
  6. There must be procedures in place for the operation and maintenance of all vehicles and equipment involved in the distribution process, including cleaning and safety precautions.
  7. Equipment chosen and used for the cleaning of vehicles must not constitute a source of contamination.
  8. Risk assessment of delivery routes must be used to determine where temperature controls are required. Equipment used for temperature monitoring during transport within vehicles and/or containers must be maintained and calibrated at regular intervals at least once a year. A procedure must also be in place for investigating and handling temperature excursions.
  9. Dedicated vehicles and equipment should be used, where possible, when handling both veterinary medicinal products and medicinal products for human use. Where non-dedicated vehicles and equipment are used, procedures must be in place to ensure that the quality of the veterinary medicinal products will not be compromised.
  10. Deliveries must be made to the address stated on the delivery note and into the care or the premises of the consignee. Veterinary medicinal products must never be left on alternative premises.
  11. For emergency deliveries outside normal business hours, persons must be designated, and written procedures must be available.
  12. Where transport is performed by a third party, the contract in place must encompass the requirements detailed in the section for Outsourced Activities, and clearly state that third party’s obligations for ensuring compliance with good distribution practice for veterinary medicinal products. The wholesale dealer must make the transport providers aware of the relevant transport conditions applicable to the consignment.
  13. Where the transport route includes unloading and reloading or transit storage at a transport hub, any intermediate storage facilities must be clean and secure and must allow for temperature monitoring, as applicable.
  14. Provision must be made to minimise the duration of temporary storage while awaiting the next stage of the transport route.
  15. The wholesale dealer remains responsible for the safety and integrity of the veterinary medicinal product until it reaches the final destination stated on the paperwork. Collections must be discouraged unless the customer is a wholesale dealer with appropriate transportation. The wholesale dealer may make documented provision for collections in the event of an emergency supply situation.

10.2 Containers, packaging and labelling

  1. The required storage conditions for veterinary medicinal products must be maintained during transportation within the limits as described by the manufacturer or on the outer packaging. Veterinary medicinal products must be transported in containers that have no adverse effect on the quality of the veterinary medicinal products and that offer adequate protection from external influences, including contamination.

  2. Selection of a container and packaging must be based on the following:

    • (i) the storage and transport requirements for the veterinary medicinal products
    • (ii) the space required for the amount of veterinary medicinal products
    • (iii) the pharmaceutical forms, also including medicated premixes
    • (iv) the anticipated external temperature extremes
    • (v) the estimated maximum time for transport including transit storage at customs
    • (vi) the qualification status of the packaging
    • (vii) the validation status of the shipping containers.
  3. Containers must bear labels providing sufficient information on handling and storage requirements and precautions to ensure that the veterinary medicinal products are properly handled and secured at all times. The containers should enable the identification of the contents of the containers and the source.

10.3 Products requiring special conditions

  1. In relation to deliveries containing veterinary medicinal products requiring special conditions such as narcotics or psychotropic substances, the wholesale dealer must maintain a safe and secure supply chain for these products in accordance with the legislative requirements. There must be additional control systems in place for delivery of these products.
  2. There must be a protocol to address the occurrence of any theft. Any theft of veterinary medicinal products whether from the authorised site or in transit, must be reported to the VMD. Any theft of veterinary controlled drugs must be reported to the police, the Home Office and the VMD.
  3. Veterinary medicinal products comprising highly active materials must be transported in safe, dedicated and secure containers and vehicles in accordance with the applicable safety measures.
  4. For temperature-sensitive veterinary medicinal products, equipment subject to qualification, such as thermal packaging, temperature-controlled containers or temperature-controlled vehicles, must be used to ensure that correct transport conditions are maintained between the manufacturer, wholesale distributor and customer, unless stability of the product has been demonstrated with other transport conditions.
  5. If temperature-controlled vehicles are used, the temperature monitoring equipment used during transport must be maintained and subject to calibration at regular intervals. Temperature mapping under representative conditions must be carried out and must take into account seasonal variations.
  6. If requested by customers with adequate justification or in the event of incident, the wholesale dealer must provide the customers with information to demonstrate that veterinary medicinal products have complied with the temperature storage or transport conditions.
  7. If cool-packs are used in insulated boxes, they must be placed in such a way to ensure the veterinary medicinal product does not come in direct contact with the cool-pack.
  8. Personnel must be trained on the procedures for assembly of insulated boxes, including variations of packing used seasonally, and on the reuse of cool-packs. The wholesale dealer must have a system in place to control the re-use of cool-packs to ensure that incompletely cooled packs are not used in error.
  9. The wholesale dealer must have in place a procedure for delivery of sensitive veterinary medicinal products and control of seasonal temperature variations.