171.—(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 under [F1—
(i)in the case of a product for sale or supply in Northern Ireland, Regulation (EC) No 726/2004, and
(ii)in the case of a product for sale or supply in Great Britain, 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).
Textual Amendments
F1Reg. 171(2)(c)(i)(ii) substituted for words in reg. 171(2)(c) (31.12.2020) by S.I. 2019/775, reg. 137 (as amended by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 105); 2020 c. 1, Sch. 5 para. 1(1)