FOI release

Freedom of Information request on report from: SMITHKLINE BEECHAM LIMITED INSP GMP 10592/1524-0020. ( FOI 21/1108)

Published 26 May 2022

FOI 21/1108

16th November 2021

Dear,  

Thank you for your request dated 8th November 2021.

Please accept our apologies for omitting the following report from our original response: SMITHKLINE BEECHAM LIMITED INSP GMP 10592/1524-0020.

You will see that some information has been redacted. The relevant sections of the Freedom of Information Act are marked at the side of each redaction. These are:

 • Section 40 – This information contains elements of personal data, the disclosure of which would be unfair in that it would breach the first principle of the Data Protection Act which says that information must be processed fairly and lawfully.

 • Section 43 – Release of all, or part of, the information would, or would be likely to, cause harm to the third party’s commercial interests.

 We have considered the balance of the public interest when applying this exemption. The exemption is to safeguard the commercially sensitive information / industrial secrets of a third party / commercial enterprise (which can include a Government Department). 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. In this case I 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) .

 We would like to inform you that there are no reports issued corresponding to the following references:

6234548 Copy of all documents related to INSP GMP 17901/10117-0045 for the 29-January-2021 inspection of ASTRAZENECA UK LIMITED located in MACCLESFIELD , UNITED KINGDOM  
6234553 Copy of all documents related to INSP GMP 19437/104762-0017 for the 23-December-2020 inspection of MEDIMMUNE UK LIMITED located in LIVERPOOL , UNITED KINGDOM – no report issued  
6234555 Copy of all documents related to INSP GDP 10592/1524-0021 for the 18-December-2020 inspection of SMITHKLINE BEECHAM LIMITED located in IRVINE , UNITED KINGDOM  
6234558 Copy of all documents related to INSP IMP 10947/1802-0015 for the 17-December-2020 inspection of TEVA NI LIMITED located in LARNE , UNITED KINGDOM  
6234559 Copy of all documents related to INSP IMP 10947/1802-0016 for the 17-December-2020 inspection of TEVA NI LIMITED located in LARNE , UNITED KINGDOM  

If you have a query about this letter, please do not hesitate to contact us at IE&SFOI@mhra.gov.uk

 If you are unhappy with our decision, you may ask for it to be reviewed. That review will be undertaken by a senior member of the Agency who has not previously been involved in your request. If you wish to pursue that option please email: info@mhra.gov.uk

 Due to the ongoing Covid-19 situation, we are not able to accept delivery of any documents or correspondence by post or courier to any of our offices.

 After that, if you remain dissatisfied, you may write to the Information Commissioner at;

The Information Commissioner’s Office

Wycliffe House

Water Lane

Wilmslow

Cheshire

SK9 5AF

They will make a decision on whether or not we have interpreted the FOIA correctly in handling your request.

 Yours sincerely

 IE&S FOI Team

MHRA

Inspection, Enforcement and Standards