EC publishes new guidelines for distribution of medicinal products

On the 7th March 2013, the The Guidelines on the Good Distribution Practice of Medicinal Products for Human Use (2013/C 68/01) were issued by the European Commission. The revised guidelines enter into force September 7th 2013.

Here are some useful excerpts
“It is the responsibility of the supplying wholesale distributor to protect medicinal products against breakage, adulteration and theft, and to ensure that temperature conditions are maintained within acceptable limits during transport. Regardless of the mode of transport, it should be possible to demonstrate that the medicines have not been exposed to conditions that may compromise their quality and integrity. A risk based approach should be utilised when planning transportation.”

The required storage conditions for medicinal products should be maintained during transportation within the defined limits as described by the manufacturers or on the outer packaging.

If a deviation such as temperature excursion or product damage has occurred during transportation, this should be reported to the distributor and recipient of the affected medicinal products. A procedure should also be in place for investigating and handling temperature excursions.
Risk assessment of delivery routes should be used to determine where temperature controls are required. Equipment used for temperature monitoring during transport within vehicles and/or containers, should be maintained and calibrated at regular intervals at least once a year.
Dedicated vehicles and equipment should be used, where possible, when handling medicinal products. Where non-dedicated vehicles and equipment are used procedures should be in place to ensure that the quality of the medicinal product will not be compromised.
Where transportation is performed by a third party, the contract in place should encompass the requirements of Chapter 7. Transporters should be made aware by the wholesale distributor of the relevant transport conditions applicable to the consignment. Where the transportation route includes unloading and reloading or transit storage at a transportation hub, particular attention should be paid to temperature monitoring, cleanliness and the security of any intermediate storage facilities.
Provision should be made to minimise the duration of temporary storage while awaiting the next stage of the transportation route.

“Containers should bear labels providing sufficient information on handling and storage requirements and precautions to ensure that the products are properly handled and secured at all times. The containers should enable identification of the contents of the containers and the source.”
For more information, follow this link to a downloadable PDF.