The Human Medicines Regulations 2012

Exemption for supply in the event or anticipation of pandemic disease

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, an NHS body or the Health Protection Agency;

(b) specifies the symptoms of and 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.