F1Orders, supply and use of cannabis-based products for administration16A

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).