Freedom of Information request on request of regulatory documents (FOI 20-583)
Published 24 March 2021
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Thank you for your information request, dated 21 December, where you asked “I should be most grateful if we could obtain the following documents for the medicinal product “ Fentanyl 50 microgram/ml Injection “, PL 01502/0062 , MAH: hameln pharma ltd - Clinical Overview - Preclinical Overview - Risk Management Plan - Public Assessment Report”
I can confirm that the MHRA does hold some of the information that you have requested. However, we have also determined that the information is exempt under Section 12 of the Freedom of Information Act and we cannot process your request any further.
Section 12 of the Act allows public authorities to refuse requests where the cost of dealing with them would exceed the appropriate limit, which for central government is set at £600. This represents the estimated cost of one person spending 24 working hours in determining whether the department holds the information, locating, retrieving and extracting the information.
We advise that you narrow your request by, for example asking for this information for one PL number.
Please note that substantially similar requests made within 60 working days of an original request can be aggregated into one for the purposes of calculating a cost limit, meaning that section 12 could still apply.
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 would 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 Telephone 0203 080 6000