Regulation 2 Amendment of regulation 2 of the Pharmaceutical Regulations

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

At the appropriate places insert—

• ““dispensing doctor” means a doctor authorised or required by the Board under regulation 12 to provide pharmaceutical services to a patient;”;

• ““serious shortage protocol” means—

  1. (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^f1 (sale etc by a pharmacist in accordance with a serious shortage protocol); or

  2. (b)

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

     1. (i)

        is issued by the Department in circumstances where Northern Ireland or any part of Northern Ireland is, in the opinion of the Department, experiencing or may experience a serious shortage of—

        1. (aa)

           a specified drug or appliance, or

        2. (bb)

           drugs or appliances of a specified description,

     2. (ii)

        provides for the supply by a provider of pharmaceutical services, where there is an order on a prescription form or a repeatable prescription for—

        1. (aa)

           the specified drug or appliance, or

        2. (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

     3. (iii)

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

• ““SSP” means a serious shortage protocol;”.