Dangerous Drugs, England And Wales Citation, commencement, interpretation and extent 1 1 These Regulations may be cited as the Misuse of Drugs (Amendments) (Cannabis and Licence Fees) (England, Wales and Scotland) Regulations 2018, and come into force on 1st November 2018. 2 In these Regulations— “the 2001 Regulations” means the Misuse of Drugs Regulations 2001 ; “the 2010 Regulations” means the Misuse of Drugs (Licence Fees) Regulations 2010 ; and “the 2015 Order” means the Misuse of Drugs (Designation) (England, Wales and Scotland) Order 2015 . 3 These Regulations extend to England and Wales and Scotland. Amendment of the Misuse of Drugs Regulations 2001 2 The 2001 Regulations are amended in accordance with regulations 3 to 7. Amendment of regulation 2 of the 2001 Regulations 3 In regulation 2(1) of the 2001 Regulations (interpretation) at the appropriate places insert— “cannabis-based product for medicinal use in humans” means a preparation or other product, other than one to which paragraph 5 of part 1 of Schedule 4 applies, which— is or contains cannabis, cannabis resin, cannabinol or a cannabinol derivative (not being dronabinol or its stereoisomers); is produced for medicinal use in humans; and— is— a medicinal product, or a substance or preparation for use as an ingredient of, or in the production of an ingredient of, a medicinal product; ; “clinical trial” has the same meaning as in the Medicines for Human Use (Clinical Trials) Regulations 2004 ; ; “dronabinol” does not include any substance which— has the international non-proprietary name dronabinol (recommended by the World Health Organisation); and is derived from cannabis, cannabis resin or their constituents, and stereoisomers of dronabinol are to be construed accordingly;; and ; and “medicinal product” has the same meaning as in the Human Medicines Regulations 2012 ; . New regulation 16A of the 2001 Regulations 4 After regulation 16 of the 2001 Regulations (provisions as to supply on prescription), insert— Orders, supply and use of cannabis-based products for administration 16A 1 Subject to paragraph (4), a person shall not order (whether by issuing a prescription or otherwise) a cannabis-based product for medicinal use in humans for administration, unless that product is— a a special medicinal product that— i is not also an investigational medicinal product, but ii is for use in accordance with a prescription or direction of a specialist medical practitioner; b an investigational medicinal product without a marketing authorisation that is for use in a clinical trial; or c a medicinal product with a marketing authorisation. 2 Subject to paragraph (4), a person shall not supply a cannabis-based product for medicinal use in humans by way of or for the purpose of the administration of that product, unless the supply— a is pursuant to an order that complies with paragraph (1); and b is— i in the case of a product that is a special medicinal product but is not also an investigational medicinal product, for use in accordance with a prescription or direction of a specialist medical practitioner, ii in the case of a product that is an investigational medicinal product without a marketing authorisation, for use in a clinical trial, or iii of a medicinal product with a marketing authorisation. 3 A person shall not self-administer a cannabis-based product for medicinal use in humans by the smoking of the product (other than for research purposes in accordance with regulation 13); 4 Nothing in this regulation shall have effect in relation to the order or supply of a cannabis-based product for medicinal use in humans for administration to animals for research purposes. 5 In this regulation, “investigational medicinal product”, “marketing authorisation”, and “special medicinal product” have the same meanings as in the Human Medicines Regulations 2012 . 6 In this regulation, “specialist medical practitioner” means a doctor included in the register of specialist medical practitioners kept under section 34D of the Medical Act 1983 (the Specialist Register). . Amendment of regulation 18 of the 2001 Regulations 5 In regulation 18 of the 2001 Regulations (marking of bottles and other containers), in paragraph (3), omit the definition of “clinical trial”. Amendment of Schedule 1 to the 2001 Regulations 6 In Schedule 1 to the 2001 Regulations (controlled drugs subject to the requirements of regulations 14, 15, 16, 18, 19, 20, 23, 26 and 27), after paragraph 5 insert— 6 But paragraphs 1 to 5 do not include a cannabis-based product for medicinal use in humans. . Amendment of Schedule 2 to the 2001 Regulations 7 In Schedule 2 to the 2001 Regulations (controlled drugs subject to the requirements of regulations 14, 15, 16, 18, 19, 20, 21, 23, 26 and 27)— a in the heading, after “16,” insert “16A,”; b in paragraph 1, at the appropriate place insert “Cannabis-based product for medicinal use in humans”; and c after paragraph 5 insert— 5A But paragraphs 2 to 5 only apply in respect of a cannabis-based product for medicinal use in humans if the cannabis-based product that would, as a consequence of paragraphs 2 to 5, be specified in this Schedule but for the operation of this paragraph, is produced for medicinal use in humans. . Amendment of the Misuse of Drugs (Licence Fees) Regulations 2010 8 1 The 2010 Regulations are amended as follows. 2 After regulation 2(5) (prescribed fee), insert— 6 No fee is payable in respect of a licence where the Secretary of State determines that the fee should be waived. . Amendment of the Misuse of Drugs (Designation) (England, Wales and Scotland) Order 2015 9 1 Schedule 1 to the 2015 Order (which specifies the controlled drugs to which section 7(4) of the Misuse of Drugs Act 1971 applies) is amended as follows. 2 In paragraph 1(a) of Part 1 — a after “Cannabinol” insert “(not being the product specified in paragraph 10(1) or (2))”; b after “Cannabinol derivatives not being dronabinol or its stereoisomers” insert “(and not being the product specified in paragraph 10(1) or (2))”; c for “Cannabis (not being the substance specified in paragraph 4 of Part 2 of this Schedule)”, substitute “Cannabis (not being the substance specified in paragraph 9 or product specified in paragraph 10(1) or (2))”; and d after “Cannabis resin” insert “(not being the product specified in paragraph 10(1) or (2))”. 3 In Part 2 (which specifies controlled drugs excepted from Part 1), after paragraph 9 insert— 10 1 A cannabis-based product for medicinal use in humans. 2 A product which is— a specified in Part 1 as a consequence of the application of paragraphs 2 to 5 to a preparation or other product (not being the substance specified in paragraph 9) which is or contains cannabis, cannabis resin, cannabinol or a cannabinol derivative (not being dronabinol or its stereoisomers); and b produced for medicinal use in humans. 3 In this paragraph— “cannabis-based product for medicinal use in humans” means a preparation or other product (not being the substance specified in paragraph 9), which— is or contains cannabis, cannabis resin, cannabinol or a cannabinol derivative (not being dronabinol or its stereoisomers); is produced for medicinal use in humans; and is— a medicinal product, or a substance or preparation for use as an ingredient of, or in the production of an ingredient of, a medicinal product; and “medicinal product” has the same meaning as in the Human Medicines Regulations 2012 . 4 In this Schedule, “dronabinol” does not include any substance which— a has the international non-proprietary name dronabinol (recommended by the World Health Organisation); and b is derived from cannabis, cannabis resin or their constituents, and stereoisomers of dronabinol are to be construed accordingly. . Nick Hurd Minister of State Home Office 9th October 2018