The MHRA inspectors have said that they are now focusing on the transport of medicines, and that more “Majors and Criticals” will be issued if UK wholesalers are not compliant. RPs have had over 3 years now to affect the changed required by current GDP guidelines.
RPs must have a Transport Qualification and Risk Assessment Plan in place. They must have mitigated as many of the risks as possible and they must have tested their assumptions and can show the evidence if requested.
Ex works do not negate your responsibility! You must have a robust QTA in place and have the responsibilities clearly defined. If your customer turns up to collect with an unsuitable vehicle, then you should not load the shipment. You should know where the shipment is going, especially if it is to be Exported. You must be able to assure the MHRA inspectors that the medicines will not end up in the UK or EU for sale and that they have been Exported.
You need to know what Incoterms you should be using and you need to know who is responsible for completing the paperwork! If you are not sure you need to go on an Export course. PCL carry out Export training every month. If you would like more information, contact Ryan@pharmacyconsulting.co.uk. If you need more help with QTAs or Transport Qualification or Risk Assessments PCL RPs are happy to help.