GDP: MHRA concerned about Qualification of Customers

In a first blog, the U.K. Medicines and Healthcare Products Regulatory Agency (MHRA) reminded companies to properly qualify their suppliers. In a recent blog just published it is pointed out that it is equally important to deliver medicines only to authorised organisations and qualified prescribers, like wholesalers or persons entitled to supply or administer medicines receive medicinal products.

Especially (but not only) products with a potential for misuse are in the focus. MHRA reports that "certain medicines subject to abuse, commonly diazepam, nitrazepam, zopiclone, tramadol and zolipdem have been leaking from the regulated supply chain and made available for sale in the black market and on illegal websites".

This does mean that in the distribution chain not only suppliers have to be qualified but also recipients. The respective "checks that should be made are similar to the qualification of suppliers" (as described in the previous blog). For supplies to pharmacies, hospitals and clinics it is "particularly important that the usage pattern is considered when fulfilling orders". MHRA is reporting that the inspectorate has seen "pharmacies ordering up to a 2000 packs of these products monthly. In the blog it is recommended that there should be a "procedure in place that sets defined limits to the size of routine orders that can be placed by customers that alert the company Responsible Person to investigate if excessive amounts are ordered."

Please also see the MHRA Inspectorate Blog "Qualification of customers, what wholesalers need to know".