Regulation 247 Exemption for supply in the event or anticipation of pandemic disease

United Kingdom

(1)

Regulations 214(1), 220 and 221 do not apply to the supply of a medicinal product that meets the following conditions.

(2)

Condition A is that the supply is made whilst a disease is, or in anticipation of a disease being imminently—

(a)

pandemic; and

(b)

a serious risk, or potentially a serious risk, to human health.

(3)

Condition B is that the supply is accordance with a protocol that—

(a)

is approved by the Ministers F1or an NHS body;

(b)

specifies F2how the medicinal product is to be used for the prevention of or as a treatment for the disease; and

(c)

contains requirements as to the recording of—

(i)

the name of the person who supplies the product to the person to be treated (“the patient”) or to a person acting on the patient's behalf, and

(ii)

evidence that the product was supplied to the patient or to a person acting on the patient's behalf.

F3(4)

A function of the Ministers under this regulation may be exercised by either of them acting alone or both of them acting jointly (and the reference in this regulation to “the Ministers” is to be read accordingly).

Annotations

Textual amendments

F1: Words in reg. 247(3)(a) substituted (1.4.2013) by The National Treatment Agency (Abolition) and the Health and Social Care Act 2012 (Consequential, Transitional and Saving Provisions) Order 2013 (S.I. 2013/235), art. 1(2), Sch. 2 para. 176(6)(a) (with Sch. 3 para. 28)
F2: Words in reg. 247(3)(b) substituted (6.11.2020) by The Human Medicines (Coronavirus and Influenza) (Amendment) Regulations 2020 (S.I. 2020/1125), regs. 1(2), 13 and words in reg. 247(3)(b) substituted (N.I.) (6.11.2020) by The Human Medicines (Coronavirus and Influenza) (Amendment) Regulations 2020 (S.R. 2020/349), regs. 1(2), 13
F3: Reg. 247(4) inserted (1.4.2013) by The National Treatment Agency (Abolition) and the Health and Social Care Act 2012 (Consequential, Transitional and Saving Provisions) Order 2013 (S.I. 2013/235), art. 1(2), Sch. 2 para. 176(6)(b) (with Sch. 3 para. 28)

Notes on Part 12

Modifications

C1: Pt. 12 modified (E.W.) (1.10.2015) by The Nicotine Inhaling Products (Age of Sale and Proxy Purchasing) Regulations 2015 (S.I. 2015/895), regs. 1(3), 4(2)