Freedom of Information request on reclassification applications for carbocisteine and/or acetylcysteine (FOI 21/723)
Published 29 December 2021
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This publication is available at https://www.gov.uk/government/publications/freedom-of-information-responses-from-the-mhra-week-commencing-26-july-2021/freedom-of-information-request-on-reclassification-applications-for-carbocisteine-andor-acetylcysteine-foi-21723
26th July 2021
FOI 21/723
Dear
Thank you for your information request, dated 25 June 2021, where you asked for a copy of the answer to an FOI request made on 7 October 2005 (Ref: 05/323) for redacted copies of the assessors’ report regarding reclassification applications for carbocisteine and/or acetylcysteine.
Our retention policy for FOIs is that they are kept for eight years, and we do not have a copy of FOI 05/323 from 2005. Therefore, your request for this information has been processed as a new request.
I am pleased to provide you with the information requested, see below.
- The redacted assessment report from 1995 for the prescription-only medicine to pharmacy reclassification of carbocisteine which concluded that pharmacy legal status is inappropriate. This report is attached as Annex 1.
- There have been no applications submitted for the reclassification of acetylcysteine.
Redactions have been made to the assessment report as some information is exempt from release under sections:
Section 40 – Personal information: Section 40 protects personal data, the disclosure of which would breach one or more of the data protection principles. The Agency is satisfied that disclosure here would breach the first data protection principle, in particular the requirement of fairness on the basis that disclosure would not be reasonably expected by the people mentioned in the information.
Section 41 – Information provided in confidence: information provided to us in confidence, with the expectation that it will not be released, is exempt from disclosure under the FOI Act. Information will be covered by Section 41 if: it was obtained by the authority from any other person; its disclosure would constitute a breach of confidence; a person or organisation could bring a court action for that breach of confidence; and that court action would be likely to succeed.
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.
The Freedom of Information Act only entitles you to access to information – the information supplied is subject to Crown copyright, and there are some restrictions on its re-use. For information on the reproduction or re-use of MHRA information, please visit https://www.gov.uk/government/publications/reproduce-or-re-use-mhra-information/reproduce-or-re-use-mhra-information.
If you have a query about the information provided, please reply to this email.
Yours sincerely,
FOI Team,
Vigilance and Risk Management of Medicines Division