FOI release

Freedom of Information request (FOI 22/1135)

Published 17 January 2024

FOI 22/1135

12th December 2022

Dear

Thank you for your information request, dated 22 November 2022, where you asked for:

“i). Please can the MHRA confirm that Tyrothricin in a throat lozenge, indicated for sore throat, was reclassified from Pharmacy to Prescription Only Medicine e.g. PL 0014/5172R and PL 15513/0352?

ii). If this is the case, under which criteria were Tyrothricin containing lozenges indicated for sore throat reclassified to a prescription only medicine? Was this related to concern for antibiotic resistance?

iii). Was this decision linked to the CHM review 34 from the HMR CHM BPC annual report 2019 stating “The Commission considered the appropriateness of P classification for an oral antibiotic and advised that, in principle, P classification was not appropriate.”? Reference

Products containing tyrothricin in a throat lozenge are no longer available on the UK market. In 2018 advice was sought from the Commission on Human Medicines (CHM) on the appropriateness of an antibiotic in an over the counter (OTC) throat lozenge and CHM advised that the use of antibiotic containing lozenges to treat sore throats was not clinically appropriate. The government is committed to supporting the international initiative on antimicrobial resistance and responsible use of antibiotics.

Please note that the CHM’s consideration of this issue was referenced on page 8 of the 2018 CHM annual report1 and not the 2019 annual report you have referred to.

If you disagree with how we have interpreted the Freedom of Information Act 2000 with regards to your request, you can ask for the decision to be reviewed. The review will be carried out by a senior member of the Agency who was not involved with the original decision.

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Yours sincerely

MHRA Customer Experience Centre