This note is not part of the regulations, but is intended to indicate their general effect.
These regulations, which come into force on 18 September 2004, make amendments to the Medicines Regulations 1984 (
“the principal regulations”). All of the amendments, except the insertion of new Part 7B, are consequential on amendments made to the Medicines Act 1981 by the Medicines Amendment Act 2003.
The Medicines Amendment Act 2003 (which also comes into force on 18 September 2004) provides for a new licensing regime for operating pharmacies. The majority of amendments made to the principal regulations by these regulations relate to that new regime and include—
•an application form for a licence to operate a pharmacy (new regulation 45A):
•the fee for making an application for a licence to operate a pharmacy (new regulation 61(1)(g)):
•the form of a licence to operate a pharmacy (new form 7 added to Schedule 2).
New regulation 45 recasts the existing regulation 45 of the principal regulations in light of new regulation 45A, which provides specifically for an application for a licence to operate a pharmacy. Regulation 45 could no longer refer broadly to applications for licences under the Medicines Act 1981, rather it must only refer to applications for licences to manufacture, hawk, sell, or pack medicines. Regulation 12 of these regulations clarifies that if a person holds a licence to manufacture, hawk, sell, or pack medicine before the commencement of these regulations, he or she need not reapply for a licence before that existing licence expires.
New Part 7B (inserted into the principal regulations by regulation 3), provides that a person may, in the course of business carried on by that person, supply a restricted medicine or a pharmacy-only medicine if he or she is authorised to supply that medicine in accordance with a standing order and supplies the medicine in accordance with that standing order. New regulation 44D—
•reflects 1 of the amendments made to the definition of standing order in section 2(1) of Medicines Act 1981 by section 3 of the Medicines Amendment Act (No 3) 2003. That amendment inserted a new paragraph (c) into the definition of standing order which enabled standing orders to be issued in relation to restricted medicine and pharmacy-only medicine. Previously, standing orders were only able to be issued in relation to prescription medicine; and
•supplements (as new regulation 44D(2) provides) the circumstances set out in section 18(1)(b) and (c) of the Medicines Act 1981 in which a person may supply a restricted medicine or pharmacy-only medicine; and
•mirrors section 18(1)(a)(ii) of the Medicines Act 1981, which provides that a prescription medicine may be supplied in accordance with a standing order.