Transport requirements
1. The persons referred to in Article 1(2) supplying veterinary medicinal products shall be responsible for protecting those veterinary medicinal products against breakage, adulteration and theft, and for ensuring that temperature conditions are maintained within acceptable limits during transport and shall, whenever possible, monitor such conditions.
2. During transport, the required storage or transport conditions, as appropriate, for veterinary medicinal products shall be maintained within the defined limits as described by the manufacturers and marketing authorisation holders or as stated on the outer packaging.
3. If a deviation such as temperature excursion or veterinary medicinal product damage has occurred during transport, this shall be reported to the persons referred to in Article 1(2) and to the consignee of the affected veterinary medicinal products in order for them to assess the potential impact on the quality of the veterinary medicinal products concerned. A procedure shall be in place for investigating and handling temperature excursions.
4. The persons referred to in Article 1(2) shall 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.
5. There shall be procedures in place for the operation and maintenance of all vehicles and equipment involved in the distribution process, including cleaning and safety precautions.
6. Equipment chosen and used for the cleaning of vehicles shall not constitute a source of contamination.
7. Risk assessment of delivery routes shall be used to determine where temperature controls are required. Equipment used for temperature monitoring during transport within vehicles or containers shall be maintained and subject to calibration at regular intervals determined on the basis of quality risk management principles.
8. Dedicated vehicles and equipment shall 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 shall be in place to ensure that the quality of the veterinary medicinal products will not be compromised.
9. Deliveries shall be made to the address stated on the delivery note and into the care or the premises of the consignee. Veterinary medicinal products shall never be left on alternative premises.
10. For emergency deliveries outside normal business hours, persons shall be designated and procedures shall be available.
11. Where transport is performed by a third party, the contract in place shall encompass the requirements of Articles 33 and 34 and clearly state that third party’s obligations for ensuring compliance with good distribution practice for veterinary medicinal products. The persons referred to in Article 1(2) shall make transport providers aware of the relevant transport conditions applicable to the consignment.
12. Where the transport route includes unloading and reloading or transit storage at a transport hub, any intermediate storage facilities shall be clean and secure and shall allow for temperature monitoring, as applicable.
13. Provision shall be made to minimise the duration of temporary storage while awaiting the next stage of the transport route.
Containers, packaging and labelling
1. Veterinary medicinal products shall 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 shall be based on the following:
(a)
the storage and transport requirements for the veterinary medicinal products;
(b)
the space required for the amount of veterinary medicinal products;
(c)
the pharmaceutical forms, also including medicated premixes;
(d)
the anticipated external temperature extremes;
(e)
the estimated maximum time for transport including transit storage at customs;
(f)
the qualification status of the packaging;
(g)
the validation status of the shipping containers.
3. Containers shall 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 shall enable identification of the contents of the containers and the source.
Products requiring special conditions
1. In relation to deliveries containing veterinary medicinal products requiring special conditions such as narcotics or psychotropic substances, the persons referred to in Article 1(2) shall maintain a safe and secure supply chain for these products in accordance with requirements laid down by the Member States concerned. There shall be additional control systems in place for delivery of these products. There shall be a protocol to address the occurrence of any theft.
2. Veterinary medicinal products comprising highly active materials shall be transported in safe, dedicated and secure containers and vehicles in accordance with the applicable safety measures.
3. For temperature-sensitive veterinary medicinal products, equipment subject to qualification, such as thermal packaging, temperature-controlled containers or temperature-controlled vehicles, shall 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.
4. If temperature-controlled vehicles are used, the temperature monitoring equipment used during transport shall be maintained and subject to calibration at regular intervals. Temperature mapping under representative conditions shall be carried out and shall take into account seasonal variations.
5. If requested by customers with adequate justification and in any case in the event of incident, the persons referred to in Article 1(2) shall provide the customers with information to demonstrate that veterinary medicinal products have complied with the temperature storage or transport conditions.
6. If cool-packs are used in insulated boxes, they shall be placed in such a way to ensure the veterinary medicinal product does not come in direct contact with the cool-pack.
7. Personnel shall be trained on the procedures for assembly of insulated boxes, including in function of the season, and on the reuse of cool-packs.
8. The persons referred to in Article 1(2) shall have a system in place to control the re-use of cool-packs to ensure that incompletely cooled packs are not used in error. The persons referred to in Article 1(2) shall ensure that there is adequate physical segregation between frozen and chilled ice packs.
9. The persons referred to in Article 1(2) shall describe the process for delivery of sensitive veterinary medicinal products and control of seasonal temperature variations in a procedure.
