Freedom of Information request onclarification and the MHRA assessment report Telfast 120 and 180 mg film-coated tablets (PL 04425/0157-0158) (FOI 21/697)
Published 27 April 2022
© Crown copyright 2022
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: psi@nationalarchives.gov.uk.
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-9-august-2021/freedom-of-information-request-onclarification-and-the-mhra-assessment-report-telfast-120-and-180-mg-film-coated-tablets-pl-044250157-0158-foi-21
10th August 2021 FOI 21/697
Dear
Thank you for your communication, dated 15 June 2021, in which you requested clarification and the MHRA assessment report Telfast 120 and 180 mg film-coated tablets (PL 04425/0157-0158).
I can confirm that the information outlined in your email dated 15 June 2021 is correct.
Telfast 40 mg (PL 04425/0156), 120 mg (PL 04425/0157) and 180 mg (PL04425/0158) tablets are suitable reference products for Marketing Authorisation Applications under HMR Regulation 51, 51A and 51B (equivalent to Article 10(1)) The MHRA holds no information on alternative European reference products for fexofenadine HCl.
Unfortunately, we are unable to search for all the information that you have requested. Your request for the assessment report for Telfast 40 mg Tablets may be held in our paper archives, which are stored externally. Given the ongoing COVID-19 outbreak, Agency staff are working remotely and are unable to access these paper records until further notice.
We apologise for any inconvenience caused. We have logged your request and will start processing it as soon as we have access to our archives again. Unfortunately, we are not able to confirm when that will be at the moment.
Please find a copy of the MHRA’s assessment report for Telfast 120 mg (PL 04425/0157) and 180 mg (PL04425/0158) tablets.
Confidential information has been redacted in these documents, according to Section 40 (personal information), Section 41 (Information provided in confidence) and Section 43 (Commercial interests) of the FOI Act.
Please note that Sections 40 and 41 of the FOI Act are an absolute exemption and no consideration of the public interest is required. Section 43 is a conditional exemption, 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. In this case we have not identified any issues which would benefit the public as a whole by being brought to their attention (examples of issues would be a major public health risk or a major procedural failure or irregularity).
I now consider this request closed. If you require any further information, please respond to the FOI Licensing Team at FOILicensing@mhra.gov.uk.
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: info@mhra.gov.uk.
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,
The FOI Licensing Team