The Human Medicines Regulations 2012

Exemption for supply in the event or anticipation of pandemic diseaseU.K.
This adran has no associated Memorandwm Esboniadol

247.—(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).]

Textual Amendments