Freedom of Information request (FOI 22/818)
Published 17 January 2024
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31st August 2022
FOI 22/818
Dear,
1. Introduction
I am writing in response to your request for a review of the Medicines and Healthcare products Regulatory Agency’s (‘the Agency’) reply to your FOI request 22/818.
The purpose of this review is to determine whether the Agency dealt properly and fairly with your request under the Freedom of Information Act (FOIA). In particular, it will examine the reasons why information was withheld from you.
Your original request and the Agency’s response are attached.
You stated in your request for this review that you believe the FOI response to be “factually incorrect given the specifications in European Pharmacopoeia sections 5.1.4 and 5.1.8 that specifically pertain to herbal medicine for inhalation.”.
2. Consideration of the issues
The original FOI requested the “classification by the MHRA of medical cannabis flower for inhalation under the British Pharmacopoeia or European Pharmacopoeia (i.e. Could they confirm that it is classified under 5.1.4 and/or 5.1.8 - and if so, under which section - in the latter and not as a traditional herbal medicine?) please?”
In the response provided to you on the 2nd August 2022 it was outlined that the BP Commission does not classify Cannabis Flower for Inhalation and there is no pharmacopoeial monograph, published or being elaborated in either BP or EP for a monograph for Cannabis Flower for Inhalation. This statement is true based on all the information held.
What, I believe, is helpful additional information was provided in the response provided on the 2nd August 2022 which gave the you links to the EP knowledge database so you could verify the status of the elaboration of monographs independently.
After assessing independently I can confirm that there are no licensed or registered products which meet the description of Cannabis Flower for Inhalation licensed in the UK.
In your request for an Independent Review you mention that you believe the FOI request response to be “factually incorrect given the specifications in European Pharmacopoeia sections 5.1.4 and 5.1.8 that specifically pertain to herbal medicine for inhalation.”. I don’t believe this statement supports your claim that the response to the FOI request was factually incorrect. The existence of acceptance criteria in the BP does not mean that the BP has ‘classified’ a product. For a well-established product it might be possible to provide an opinion on how these acceptance criteria might be applied but for theoretical products this is less easy.
The Agency could have provided more helpful advice if the FOI request had been clarified and dealt with as a query.
3. Conclusion and recommendations
My conclusion is that the request, as received, has been dealt with factually and there is no information on record that can be provided.
However, whilst I am of the opinion that the request has been dealt with factually, I think the Agency might have provided you with more helpful advice if your Freedom of Information request had been clarified and potentially dealt with as a query. If you are ultimately interested in what microbiological controls should apply to a theoretical product (given that there is no licensed product matching your description) then my strong recommendation is that this is a query better suited to a dialogue rather than an FOI request.
I would recommend that you contact the MHRA Customer Experience Centre and potentially re-frame your question for the specific product you are considering. The British Pharmacopoeia can provide an opinion on how the pharmacopoeia acceptance criteria in 5.1.4 or 5.1.8 might be applied to an appropriately defined product however it will ultimately be a decision for the competent authority with responsibility for the licensing/registration of medicinal products and such a decision would be based upon the details of the product, the proposed use of the product and method of manufacture.
I hope this is helpful.
If you remain dissatisfied, you may ask the Information Commissioner (ICO) to make a decision on whether or not we have interpreted the FOIA correctly in dealing with the request and subsequent internal review. The ICO’s address is:
The Information Commissioner’s Office
Wycliffe House
Water Lane
Wilmslow
Cheshire
SK9 5AF
Kind regards,
MHRA Customer Experience Centre
Communications and engagement team
Medicines and Healthcare products Regulatory Agency
10 South Colonnade, Canary Wharf, London E14 4PU