Freedom of Information request on reports of adverse reactions to the Vamousse product (FOI 21/542)
Published 28 June 2021
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27th May 2021 FOI 21/542
Dear
Thank you for your information request, dated 19th May 2021, where you asked for a copy of the report of interest regarding the claimant and copies of other reports of adverse reactions to the Vamousse product.
Unfortunately, the information is exempt from release under section
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 Tyratech Limited, 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.
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.
If you have a query about the information provided, please reply to this email.
Yours sincerely,
MHRA Customer Service Centre
Medicines and Healthcare products Regulatory Agency 10 South Colonnade, Canary Wharf, London E14 4PU