In forceAs enacted

Contents

Health Products (Cell, Tissue and Gene Therapy Products) Regulations 2021 · As enacted · Part 5 · Supply Requirements

20. Wholesale supply of Class 2 CTGT products

(1)

For the purposes of section 17(1) of the Act, the supply by wholesale of a Class 2 CTGT product by a person to another (called in this paragraph the recipient) must be in accordance with the following requirements:

(a)

there is a written order, signed by the recipient —

(i)

stating the recipient’s name and address, trade, business or profession, and the name and total quantity of the Class 2 CTGT product required for supply to the recipient; and

(ii)

that is not cancelled before the supply is carried out;

(b)

before each supply is carried out, the person must be satisfied that the recipient carries on the trade, business or profession stated in the order in sub‑paragraph (a) and that the trade, business or profession is one in which the Class 2 CTGT product is used; (c)after each supply is carried out, the person must insert in the appropriate entry in the record of supply prescribed by regulation 33(2)(b), a reference number by which the order can be identified.

(2)

Paragraph (1) does not apply to the supply by wholesale of a Class 2 CTGT product under regulation 12 or 18.

Subregulation 1

(a)

there is a written order, signed by the recipient —

(i)

stating the recipient’s name and address, trade, business or profession, and the name and total quantity of the Class 2 CTGT product required for supply to the recipient; and

(ii)

that is not cancelled before the supply is carried out;

(b)