Regulation 171 Exempt advanced therapy medicinal products

F1(A1)

This regulation does not apply to an MM medicinal product or a POC medicinal product.

(1)

The prohibitions in regulation 46 (requirement for authorisation) do not apply in relation to an advanced therapy medicinal product (an “exempt advanced therapy medicinal product”) if the following conditions are met.

(2)

Condition A is that the product is prepared—

(a)

on a non-routine basis;

(b)

in the United Kingdom; and

(c)

according to specific quality standards equivalent to those provided for advanced therapy medicinal products authorised F2under regulation 49(1).

(3)

Condition B is that the product is used—

(a)

in a hospital in the United Kingdom;

(b)

under the exclusive professional responsibility of a doctor; and

(c)

in order to comply with an individual medical prescription for a product made to order for an individual patient.

(4)

Condition C is that no advertisement relating to the medicinal product is published by any person.

(5)

Condition D is that the sale or supply of the medicinal product is in response to an unsolicited order.

(6)

In this regulation “publish” has the meaning given in regulation 277(1) (interpretation Part 14 advertising).

Annotations

Textual amendments

F1: Reg. 171(A1) inserted (23.7.2025) by The Human Medicines (Amendment) (Modular Manufacture and Point of Care) Regulations 2025 (S.I. 2025/87), regs. 1(2), 24
F2: Words in reg. 171(2)(c) substituted (1.1.2025) by The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 72