Dangerous Drugs Citation, commencement, interpretation 1 1 These Regulations may be cited as the Misuse of Drugs (Amendment No.2) Regulations (Northern Ireland) 2018 and shall come into operation on 1st November 2018. 2 The Interpretation Act (Northern Ireland) 1954 shall apply to these Regulations as it applies to an Act of the Northern Ireland Assembly. Amendment of the Misuse of Drugs Regulations (Northern Ireland) 2002 2 The Misuse of Drugs Regulations (Northern Ireland) 2002 are amended in accordance with regulations 3 to 7 below. Amendment of regulation 2 3 In regulation 2(2) (interpretation)— a 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 that is derived from cannabis, cannabis resin or their constituents, and stereoisomers of dronabinol are to be construed accordingly; ; and “medicinal product” has the same meaning as in the Human Medicines Regulations 2012 ; . New regulation 16A 4 After regulation 16 (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 5 In regulation 18 (marking of bottles and other containers), in paragraph (3), omit the definition of “clinical trial”. Amendment of Schedule 1 6 In Schedule 1 (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 apply to a cannabis based product for medicinal use in humans. . Amendment of Schedule 2 7 In Schedule 2 (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. . Sealed with the Official Seal of the Department of Health on 11th October 2018 Dr Mark Timoney A senior officer of the Department of Health