Freedom of Information request (FOI 22/1135)
Published 17 January 2024
© Crown copyright 2024
This publication is licensed under the terms of the Open Government Licence v3.0 except where otherwise stated. To view this licence, visit nationalarchives.gov.uk/doc/open-government-licence/version/3 or write to the Information Policy Team, The National Archives, Kew, London TW9 4DU, or email: [email protected].
Where we have identified any third party copyright information you will need to obtain permission from the copyright holders concerned.
This publication is available at https://www.gov.uk/government/publications/freedom-of-information-responses-from-the-mhra-week-commencing-12-december-2022/freedom-of-information-request-foi-221135
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.
If you have a query about the information provided, please reply to this email
If you are dissatisfied with the handling of your request, you have the right to ask for an internal review. Internal review requests should be submitted within two months of the date you receive this response and addressed to: [email protected]
Please remember to quote the reference number above in any future communications.
If you were to remain dissatisfied with the outcome of the internal review, you would have the right to apply directly to the Information Commissioner for a decision.
Please bear in mind that the Information Commissioner will not normally review our handling of your request unless you have first contacted us to conduct an internal review. The Information Commissioner can be contacted at:
Information Commissioner’s Office
Wycliffe House
Water Lane
Wilmslow
Cheshire
SK9 5AF
Yours sincerely
MHRA Customer Experience Centre