FOI release

Freedom of Information request on Luforbec 100/6 micrograms per actuation pressurised inhalation solution (FOI 21/1086)

Published 27 April 2022

19th October 2021

FOI 21/1086

Dear

Thank you for your email, dated 27 September 2021, in which you requested the following information concerning Luforbec 100/6 micrograms per actuation pressurised inhalation solution (PL 35507/0204):

• a copy of the PK study report and data used to support the application, together with copies of the associated Quality Overall Summary (Module 2.3), Clinical Overview (Module 2.5) and Clinical Summary (Module 2.7)

• copies of any associated minutes relating to advice provided at the Commission of Human Medicines (CHM) meeting held on 23 January 2020 and copies of additional quality, safety and efficacy data that were subsequently supplied.

In response to your request, please find attached the clinical PK study report, clinical overview and clinical summary sections (Module 2.7.1 and Module 2.7.6) submitted to support the initial application for Luforbec 100/6 micrograms per actuation pressurised inhalation solution (PL 35507/0204). The documentation has been redacted under Section 40 (Personal Information), Section 41 (Information given in confidence) and Section 43 (Commercial Interests) of the Freedom of Information (FOI) Act.

Disclosure of information subject to Section 40 (Personal information) would be an infringement of personal data. Section 40 (Personal information) is an absolute exemption and no consideration of the public interest is required.

Section 41 (Information given in confidence) is an absolute exemption, and no consideration of the public interest is necessary, except to state that the release of this information withheld under this section of the FOI Act would be considered an actionable breach by the MHRA.

We have redacted some parts of the attached documentation under Section 43 (Commercial Interests) of the FOI Act because the release of all, or part of, the information would, or would be likely to, cause harm to the third party’s commercial interests. The exemption is to safeguard the commercially sensitive information/commercial enterprise. In this case, release of information would enable the competitors to overcome several regulatory hurdles in the research and development of their own products. This exemption is conditional on the public interest in releasing it not outweighing the company’s/commercial enterprise’s right to confidentiality and the probable damage that the company/commercial enterprise could suffer as a result of the information being released. We have considered the balance of the public interest when applying this exemption. In this case, we have not identified any issues which would benefit the public, as a whole, by being brought to their attention.

The Quality Overall Summary, any associated minutes relating to advice provided at the CHM meeting held on 23 January 2020, and copies of additional quality, safety and efficacy data that were subsequently supplied are being withheld under Section 41 (Information given in Confidence), Section 43 (Commercial Information) and Section 21 (Information accessible via other means) of the FOI Act, as this information is considered commercially confidential or is already available in the public domain, e.g. can be found on our website in the Public Assessment Report for Luforbec 100/6 micrograms per actuation pressurised inhalation solution (PL 5507/0204), accessible via the below electronic link: https://products.mhra.gov.uk/.

Please note that the FOI Act’s Section 21 exemption states that there is no right of access to information via FOI if it is reasonably available to the applicant by another route.

We now consider this FOI request closed. If you have a query about this letter, please contact the MHRA FOI Licensing mailbox using the email address listed below.

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 2 months of the date you receive this response and addressed to: info@mhra.gov.uk, quoting reference FOI 21/1086.

If you are not content with the outcome of the internal review, you have the right to apply directly to the Information Commissioner for a decision. The Information Commissioner can be contacted at: Information Commissioner’s Office, Wycliffe House, Water Lane, Wilmslow, and Cheshire, SK9 5AF.

Yours sincerely,

The FOI Licensing Team