The National Health Service (Amendments Relating to Serious Shortage Protocols) (Wales) Regulations 2019

Amendment of regulation 2 of the Pharmaceutical Services Regulations

2.—(1) Regulation 2(1) of the Pharmaceutical Services Regulations(1) (interpretation) is amended as follows.

(2) At the appropriate places insert—

““serious shortage protocol” (“protocol prinder difrifol”) means—

(a)

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

(b)

in the case of any other drug or appliance, a written protocol that—

(i)

is issued by the Welsh Ministers in circumstances where Wales or any part of Wales is, in the opinion of the Welsh Ministers, experiencing or may experience a serious shortage of—

(aa)

a specified drug or appliance, or

(bb)

drugs or appliances of a specified description,

(ii)

provides for the supply by an NHS pharmacist or an NHS appliance contractor providing pharmaceutical or local pharmaceutical services, where there is an order on a prescription form or a repeatable prescription for—

(aa)

the specified drug or appliance, or

(bb)

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

(iii)

specifies the period for which, and the parts of Wales (which may be all of Wales) in which, the protocol is to have effect;”, and

““SSP” (“PPD”) means a serious shortage protocol;”.

(1)

Regulation 2 has been amended by S.I. 2014/2291 (W. 226), S.I. 2016/696, S.I. 2016/1221 (W. 292) and S.I. 2019/149 (W. 34), It is prospectively amended by S.I. 2019/1094.

(2)

S.I. 2012/1916; regulation 226A was inserted by S.I. 2019/62.