FOI release

Freedom of Information request on the safety standards for Cannabis based prescription medicines (FOI 22/766)

Published 21 December 2023

FOI 22/766

22nd July 2022

Dear,

Thank you for your email of 20th June.

The regulation of medicines on the UK market is undertaken by MHRA in accordance with the Human Medicines Regulations 2012 (SI 2012/1916).

Please find below a brief explanation of the assessment of notifications for the intent to import unlicensed medicines into the UK which we believe you may find useful.

Unlicensed medicines are also known as “specials”.

Unless exempt, a medicinal product must be the subject of a marketing authorisation (product licence) before being placed on the market. Regulation 167 of the Human Medicines Regulations 2012 provides an exemption from the need for a marketing authorisation for a medicinal product under certain circumstances. In the interest of public health the exemption is narrowly drawn because unlicensed medicines or “specials”, unlike licensed medicinal products, may not have been assessed by the Licensing Authority against the criteria of safety, quality and efficacy.

An unlicensed medicinal product may only be supplied in order to meet the special needs of an individual patient that cannot be met by a licensed available medicinal product. An unlicensed medicinal product should not be supplied where an equivalent licensed medicinal product can meet the special needs of the patient. Responsibility for deciding whether an individual patient has “special needs” which a licensed product cannot meet should be a matter for the prescriber. The requirement for a “special need” relates to the special clinical needs of the individual patient. It does not include reasons of cost, convenience or operational needs. A licensed medicinal product obtainable from normal distribution channels in a reasonable time should be considered available for use. If a licensed product becomes unavailable, it may be necessary for an unlicensed equivalent to be supplied.

Prior to the importation taking place the importer must notify the MHRA of their intent to import the medicine and provide a set of supportive documentation to allow for our assessment of the request. Each import request is assessed on a case by case basis taking into account not only the product to be imported but also the special needs identified by the prescriber. The MHRA may decide to object to the importation of the unlicensed medicine if significant safety risks are identified that may potentially outweigh the benefits for the patients. If the MHRA does not object to the importation, a letter will be issued to the importer stating the conditions under which we do not object that a certain unlicensed medicine is imported.

As off June 2022, in the interest of public health, our expectation is that tests and controls for unlicensed cannabis-based medicinal products (CBPMs) for inhalation should be aligned with Ph.Eur chapter 5.1.4.

Without prejudice to the assessment of the individual notificaitons, small deviations from these Ph. Eur 5.1.4 microbial limits would require the following written and signed confirmation from the prescriber(s), stating that:

1. The prescriber(s) have been provided with COA(s) of the unlicensed CBPMs to be imported to the UK, and these are in accordance with their specification.

2. The prescriber(s) have clinically evaluated the risks associated with the unlicensed CBPMs containing microbiological test results exceeding those specified in Ph.Eur chapter 5.1.4 (with respect to medicinal products for inhalation), or that specific tests in Ph.Eur chapter 5.1.4 have not been performed for the batches to be imported to the UK. The respective deviation(s) from the recommended test limits in Ph.Eur chapter 5.1.4 should be specified in the letter.

3. The prescriber(s) wish to proceed with the importation of batches of unlicensed CBPMs containing deviations from the specified microbiological control test limits in Ph.Eur chapter 5.1.4 (with respect to medicinal products for inhalation).

The MHRA may still object to the importation if the limits are deemed high and to potentially pose an unacceptable risk to patients. It is the obligation of the importer to demonstrate that quantities higher than established by Ph.Eur chapter 5.1.4 are safe for the patients concerned.

In response to your request for information please find the MHRA answers below:

1)

i) A copy of the quality and safety standards for the importation of CBPM’s (Cannabis based prescription medicines) for inhalation with which the MHRA requires regulated import licence holders to ensure product compliance - specifically relating to total aerobic microbial count (TAMC) and the total combined yeasts/moulds count (TYMC);

Please refer to the explanation provided above.

ii) A confirmation of whether the above standard is a legal requirement for import licence holders, or suggested but optional guidance.

Please refer to the explanation provided above. Compliance with microbial limits inscribed in Ph.Eur chapter 5.1.4 for inhalation will reduce the risk for patients being treated with CBPMs for inhalation. Higher risks may preclude a positive outcome to the assessment, negating the importation of the product.

2)

i) If the MHRA does not have a specific document detailing the above, a confirmation of whether the limits detailed in European Pharmacopoeia (Ph.Eur) 5.1.4 [‘inhaled use’] form the accepted compliance standard, except in cases when imported under specific sections of Ph.Eur 5.1.8 and the prescriber is aware of the potential risks to the patient as a result;

ii) in the rare instances where the Ph.Eur 5.1.8 specification is followed for the importation of CBPM’s for inhalation, which of the criterion in Ph.Eur 5.1.8 (A, B, or C) applies;

Microbial limits inscribed in Ph.Eur chapter 5.1.4 for inhalation should be met as closely as possible. The higher the bioburden in the finished product, the higher the perceived risk to patients. Deviations from 5.1.4 limits should be justified from a patient safety perspective as explained above.

iii) A confirmation of whether the above is a legal compliance requirement for import licence holders or suggested but optional guidance.

Please refer to the explanation provided above. Compliance with microbial limits inscribed in Ph.Eur chapter 5.1.4 for inhalation will reduce the risk for patients being treated with CBPMs for inhalation. Higher risks may preclude a positive outcome to the assessment, negating the importation of the product.

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

If you disagree with how we have interpreted the Freedom of Information Act 2000 in answering your request, you can ask for an internal review. Please reply to this email, within two months of this reply, specifying that you would like an Internal Review to be carried out.

Please remember to quote the reference number above in any future communications.

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 at:

Information Commissioner’s Office
Wycliffe House
Water Lane
Wilmslow
Cheshire
SK9 5AF

Yours sincerely

MHRA Customer Experience Centre

Communications and engagement team

Medicines and Healthcare products Regulatory Agency

10 South Colonnade, Canary Wharf, London E14 4PU
Telephone 020 3080 6000