7EmergenciesU.K.
(1)Regulations under section 2(1) may make provision about the disapplication of a human medicines provision in circumstances which give rise to a need to protect the public from a risk of serious harm to health.
(2)Regulations made in reliance on subsection (1) may provide for the disapplication to be subject to—
(a)conditions set out in the regulations;
(b)conditions set out in a protocol published by the appropriate authority.
(3)Where regulations made in reliance on subsection (1) provide that the appropriate authority may publish a protocol setting out conditions, the regulations must provide—
(a)that the appropriate authority may withdraw or amend the protocol, and
(b)that the protocol is to have effect only for a period of time specified in the protocol.