The Misuse of Drugs (Amendments) (Cannabis and Licence Fees) (England, Wales and Scotland) Regulations 2018

• Citation: S.I. 2018/1055
• Sections: 9

Section 1 Citation, commencement, interpretation and extent

(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.

Section 2 Amendment of the Misuse of Drugs Regulations 2001

The 2001 Regulations are amended in accordance with regulations 3 to 7.

Section 3 Amendment of regulation 2 of the 2001 Regulations

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

“medicinal product” has the same meaning as in the Human Medicines Regulations 2012 ;

Section 4 New regulation 16A of the 2001 Regulations

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).

Section 5 Amendment of regulation 18 of the 2001 Regulations

In regulation 18 of the 2001 Regulations (marking of bottles and other containers), in paragraph (3), omit the definition of “clinical trial”.

Section 6 Amendment of Schedule 1 to the 2001 Regulations

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.

Section 7 Amendment of Schedule 2 to the 2001 Regulations

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.

Section 8 Amendment of the Misuse of Drugs (Licence Fees) Regulations 2010

(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.

Section 9 Amendment of the Misuse of Drugs (Designation) (England, Wales and Scotland) Order 2015

(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.