8.—(1) Regulation 2(1) of the Charges Regulations(1) (interpretation) is amended as follows.
(2) At the appropriate places insert—
““serious shortage protocol” means—
in the case of a prescription only medicine, a serious shortage protocol for the purposes of regulation 226A of the Human Medicines Regulations 2012(2) (sale etc. by a pharmacist in accordance with a serious shortage protocol); or
in the case of any other drug or appliance, a written protocol that—
is issued by the Secretary of State in circumstances where England or any part of England is, in the opinion of the Secretary of State, experiencing or may experience a serious shortage of—
a specified drug or appliance, or
drugs or appliances of a specified description,
provides for the supply by a provider of pharmaceutical or local pharmaceutical services, where there is an order on a prescription form or a repeatable prescription for—
the specified drug or appliance, or
a drug or appliance of the specified description,
of a different product or quantity of product to the product or quantity of product ordered, subject to such conditions as may be specified in the protocol, and
specifies the period for which, and the parts of England (which may be all of England) in which, the protocol is to have effect;”; and
““SSP” means a serious shortage protocol;”.
Regulation 2 has been amended by S.I. 2015/1879, 2016/696 and 1077 and 2018/1114.
S.I. 2012/1916. Regulation 226A was inserted by S.I. 2019/62.