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Generics company has manufacturing licence restored


Generics company has manufacturing licence restored

The manufacturing suspension has contributed to medicine shortages

Generic medicines manufacturer Bristol Laboratories has had its good manufacturing practice (GMP) status fully restored, the company announced last week (Monday June 10).

The Medicines and Healthcare products Regulatory Agency (MHRA) partially suspended Bristol Laboratories’ manufacturing licence in August 2017 after an inspection of the company’s Luton site uncovered failure to comply with good practice.

Subsequent inspections have found continued non-compliance and led to the suspension being extended, though some of the restrictions were relaxed following an inspection in November 2018.

The partial suspension meant the company could only manufacture and distribute certain medicines judged to be critical in the EU market. This has contributed to shortages of some medicines, the Pharmaceutical Services Negotiating Committee (PSNC) has said. This partial suspension was wholly lifted on May 22.

Quality and regulatory affairs director Priti Ramachandran said that with Brexit having potential to disrupt medicines supply in the UK, the MHRA’s decision to lift the suspension “gives vital reassurance for our patients and our customers – as well as our people, our distribution network and our supply chain”.

Ramachandran added: “At Bristol Laboratories, we stand ready: we have created enough capacity to address medicine shortages.”

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