Since the application of the Falsified Medicines Directive in January, 2013 there is a new requirement that anyone involved in the export or holding of medicinal products intended for export, for wholesale distribution, now require a Wholesale Distribution Authorisation.
On the 18th August, 2014, the UK MHRA published their position on freight consolidation depots (freight forwarders) in which they clarify that any party directly or indirectly affected and any freight consolidator or freight forwarder either in the air, sea or road transport sector that is either holding ambient medicinal products on site for more that 36 hours or has cold room facilities will require a WDA(H) in order to comply.
As an WDA holder, you should now consider how you export products and how long your freight forwarder will store your products before onward shipping. If the freight forwarder hold your products for more than 36 hours, check that they hold a valid WDA(H) and are GDP Compliant as part of your Supplier approvals.
If you are a freight forwarder you may not have, previously, required a WDA(H) but may need to hold one now.
If you are unsure if you require a WDA(H) or if your freight forwarder requires one, PCL are always happy to advise – give us a call on 01252 302342