MHRA fully reinstates Bristol Labs GMP status

Published: 11-Jun-2019

The company is now well-stocked for the shortages that may be brought about by Brexit

Bristol Laboratories, the generics manufacturer, have made a statement after the full reinstatement of GMP status for its UK manufacturing facilities.

Priti Ramachandran, Director of Quality and Regulatory Affairs, said: “As one of the UK’s leading pharmaceutical manufacturers, Bristol Laboratories welcomes the full reinstatement of GMP status for our UK manufacturing facilities, following successful MHRA inspections."

Bristol Laboratories welcomes the full reinstatement of GMP status for our UK manufacturing facilities

"This news gives vital reassurance for our patients and our customers – as well as our people, our distribution network and our supply chain – as Brexit continues to present uncertainty over future medicine supply in the UK."

"We are proud of our dedicated team for their continued commitment. At Bristol Laboratories, our patients are at the heart of everything we do. This patient-first approach is reflected in our relentless pursuit of GMP compliancy and is underpinned by our quality first ethos, ensuring safety and efficacy throughout our operations and our products for the benefit of our customers and our patients. We are justly proud of our dedicated team for its continued commitment to these values."

"The ongoing support of our patients and distributors has been inspiring and has kept us motivated during these tough times and we are truly grateful to them for backing us."

Road to recovery

The suspension was officially lifted on 22 May. Up until then, the company had only been allowed to manufacture medicines deemed critical to the EU market. However, due to the large nature of the company, this caused some shortages in generic products across the market.

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,” he said.

Now that GMP status has been restored, the company is fully focused on preparing for Brexit.

We have created enough capacity to address medicine shortages

Addressing shortages and Brexit, Ramachandran added: “Brexit presents challenges for everyone in the pharmaceutical sector. At Bristol Laboratories, we stand ready: we have created enough capacity to address medicine shortages. We are delighted to uphold our position as a leading provider of medicines in the UK and internationally, remaining a trusted partner for supplying high quality and compliant products.”

With Brexit looming, this is a welcome outcome to both the company and patients in the EU.

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