The Medicines and Healthcare products Regulatory Agency (MHRA) first issued a partial suspension of the manufacturer’s licence in August 2017, after it “identified non-compliance with good manufacturing practice” during an inspection of its Luton site in July.
In April 2018, C+D reported that the suspension had been extended due to remaining “non-compliance issues”.
The MHRA told C+D yesterday (November 26) that inspections of Bristol Laboratories' site from November 13 to 15 had identified for the third time “some continued non-compliance with good manufacturing practice”.
It then ordered another extension from last week until February 22, according to its list of suspended manufacturing and wholesale licences.
However, the MHRA also said it had lifted “part” of the original suspension, so the Luton site can “restart its import activities and continue with manufacturing critical medicines”.
PSNC: Suspension is “not ideal”
Pharmaceutical Services Negotiating Committee (PSNC) director of pharmacy funding Mike Dent told C+D the suspension extension is “not ideal”.
“The spike in generic medicines shortages seen over the past 18 months, caused in part by problems at Bristol Laboratories, has had a significant impact on community pharmacies.”
Pharmacies are “working hard to ensure the continued supply of vital medicines to their patients”, he said.
“PSNC will continue to monitor generic supply and shortages very closely and apply for price concessions as appropriate.”
“No evidence of defective medicines”
The MHRA stressed there is “no evidence of the medicines [manufactured by Bristol Laboratories] being defective and therefore patients should continue to take their medicines as necessary”.
Bristol Laboratories did not respond to C+D’s request for comment.
