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13.—(1) In the circumstances set out in paragraph (2), the following drugs are exempt from any charge under these Regulations—
(a)drugs for the prevention or treatment of a condition or disease arising from an emergency that threatens, is causing or has caused serious damage or risk to public health in England or any part of England; and
(b)drugs, the supply of which is for, or is in anticipation of, a pandemic disease where the supply is in accordance with protocols relating to that disease as provided for in regulation 247 of the Human Medicines Regulations 2012(1) (exemption for supply in the event or anticipation of pandemic disease).
(2) Those circumstances are where—
(a)the Secretary of State has made arrangements for supplying the drug to patients free of charge; or
(b)the NHS body(2) that is responsible for the arrangements under which the drug is supplied has made arrangements, with the approval of the Secretary of State, for supplying the drug to patients free of charge,
and the patient is supplied with the drug under those arrangements.
S.I. 2012/1916. Regulation 247 has been amended by S.I. 2013/235.
“NHS body” is defined in section 275(1) of the National Health Service Act 2006 (c. 41).
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