FOI release

Freedom of Information request about CleanCert waterline cleaner (FOI-21-188)

Published 7 May 2021

8th March 2021

FOI 21/188

Dear

Thank you for your email, dated 11 February 2021, where you asked for:

‘1) all emails sent by MHRA to BSi UK or BSi NL concerning CleanCert waterline cleaner, 2018-2020.

2) all emails received by MHRA from BSi UK or BSi NL concerning CleanCert waterline cleaner, 2018-2020.

3) any minutes of meetings between MHRA and BSi, where CleanCert was mentioned. 2018-2020

4) any other correspondence (eg phone call transcripts) between MHRA and BSi where CleanCert was discussed. (2018-2020).’

With regards to request 1 and 2, this information is exempt from release under section 44 of the Freedom of Information (FOI) Act. Section 44 – Prohibitions on disclosure: the release of information is exempt as its disclosure is prohibited by other legislation. In this case, section 237 of the Enterprise Act 2002 prohibits a public authority from releasing information which came to it in connection with the exercise of its functions, and which relates to the affairs of an individual or business.

The MHRA is satisfied that the information you have requested: • constitutes information which came to us in connection with the exercise of the Agency’s functions. The MHRA has a duty of consumer protection under the Consumer Protection Act 1987 which is listed as a specified function under Schedule 14 of the Enterprise Act 2002, and receives information while exercising consumer protection functions in its role as the regulator of medicines and healthcare products. • relates to the affairs of BSI, a business which continues to exist.

On that basis we are satisfied that section 44 of FOI Act applies and the information is exempt from release.

With regards to request 3 and 4, I can confirm that we do not hold the information that you have requested.

If you disagree with how we have interpreted the Freedom of Information Act 2000 with regards to your request, you can ask for an internal review. It will be carried out by a senior member of the Agency who was not involved with the original decision. Internal review requests should be submitted within two months of the date you receive this response and addressed to: info@mhra.gov.uk.

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 online: https://ico.org.uk/

If you have a query about the information provided, please reply to this email.

Yours sincerely Enquiries Co-ordinator Devices Division Medicines and Healthcare Products Regulatory Agency 10 South Colonnade, Canary Wharf, London E14 4PU