FOI release
FOI - Regulation 16A(3) Patient Communication - GPhC
Case reference FOI2026/00667
Received 21 June 2026
Published 12 August 2026
Request
Dear MHRA Freedom of Information Team, This request is made under the Freedom of Information Act 2000. It is submitted as part of an ongoing, transparent research programme examining the regulatory, criminal-law, equality, and real-world impacts of the framework governing cannabis-based products for medicinal use (CBPMs). The programme builds on material previously submitted to the Advisory Council on the Misuse of Drugs (ACMD) Call for Evidence on CBPMs, which closed on 17 October 2025, and on subsequent analytical updates and correspondence provided to the ACMD as the evidence base has continued to develop. Background Attached are Department of Health and Social Care responses FOI-1683941 and FOI-1688183. In those responses DHSC states, amongst other things, that: • responsibility for informing patients how to take prescribed medicines rests with prescribers and dispensing pharmacies; • product labels and clinics would be expected to communicate information concerning the correct route of administration; • healthcare regulators are responsible for ensuring healthcare professionals meet professional standards; and • DHSC would expect communication to specify in clear terms that smoking prescribed cannabis-based products for medicinal use is illegal and therefore a criminal offence. Also attached is a Patient Communication Evidence Pack containing representative examples of patient-facing packaging and dispensing labels supplied with prescribed cannabis-based products for medicinal use. The examples demonstrate communication of matters including: • route of administration; • vaporisation instructions; • smoking warnings; • storage requirements; • controlled-drug status; and • driving-related warnings. FOI_1D1b - MHRA 19/06/2026 This request concerns recorded information relating to communication to patients of the legal consequences arising from Regulation 16A(3) of the Misuse of Drugs Regulations 2001. For clarity: • this request concerns formally recorded information only; • it does not seek draft material; • it does not seek informal communications; • it does not seek legal advice; • it does not seek opinions regarding the merits of the policy. Requested Information 1. Has MHRA considered whether patient-facing information relating to prescribed cannabis-based products for medicinal use should communicate the legal consequences arising from Regulation 16A(3) of the Misuse of Drugs Regulations 2001? 2. If the answer to Question 1 is yes, please provide the records documenting that consideration. 3. If the answer to Question 1 is no, please identify any organisation, authority or office-holder regarded as responsible for considering that issue. 4. If MHRA has not considered the issue itself, does MHRA hold any recorded information identifying any requirement, expectation or mechanism through which communication of those legal consequences should occur?
Response
See attached
Documents
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