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Logistics companies in the UK, which are transporting or holding medicines for people or animals, may need to attain Wholesale Distribution Authorisation (WDA) from the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA), or ensure relevant parties in the supply chain are compliant.
The rule was introduced in September 2013, but many in the logistics industry are still not aware of the change.
But at this week’s Life Sciences and Pharmaceutical conference in London, Cheryl Blake, an inspector for MHRA, warned forwarders, handlers and carriers that they may have to comply with this rule – and that it was likely to extend throughout Europe.
Any UK company exporting, holding or storing medicines needed an WDA, she said. “That could be freight consolidators or forwarders, Customs sheds and bonded facilities.”
‘Exports’ are defined as goods leaving the European economic area, while ‘holding’ and ‘storing’ mean having the medicines for 36 hours or more, or having active refrigeration for the shipment, or having any direct intervention with the shipment. “Transport,” she confirmed, “ie moving without storing for unjustified periods of time, does not need a WDA.”
Ms Blake added: “We are not trying to bury you in paperwork, and it is unlikely that a forwarder will require a WDA unless they are ‘holding’ a product.”
But she warned: “Companies will need to exercise due diligence when selecting transport routes and entering into contracts. The WDA is site specific. Poor transport planning and control can lead to costly product recalls. So forwarders will need to take a risk assessment of delivery routes and book appropriate transport.”
The news alarmed some companies which were concerned about a potential lack of compliance. One delegate asked if a ground handler which had refrigerated facilities in the UK needed to apply for a WDA.
One major handler said: “I don’t hold product for 36 hours – we are a transit shed not a storage shed – but at weekends we are sometimes used for storage.”
Ms Blake confirmed: “If the handler is the owner of the building and responsible for making sure the controls are there, then it will need a WDA. Airlines too – depending on their arrangements – may also need licences. It would depend on their contracts.”
One of the reasons for the ruling, which aligns with standards set by Good Distribution Practice (GDP), is to keep the supply chain free from counterfeit drugs.
“Medicinal products must stay in the regulated supply chain, which will prevent falsified medicinal products from getting into the legal supply chain,” explained Ms Blake. “We need to keep the supply chain tight.”
She admitted that the agency had some way to go in publicising the 15-month old ruling. “We are playing catch up – there are a lot of sheds now under the legislative framework, but we can’t just put the onus on to pharma companies to ensure everyone in the chain is compliant.”
Some delegates said the MHRA website outlining the change was “confusing”.
Yesterday IAG Cargo announced that it was the first airline to be granted the WDA. It said in a statement: “Accredited GDP/WDA shippers will select carriers that have a GDP/WDA licence over those that do not, handing IAG Cargo a significant competitive advantage.”
Reinier Danckaarts, Europe air competence director for Kuehne + Nagel, said the rule had “huge implications”.