Notice Type
Departmental
Classification of Medicines Pursuant to section 106 (1) of the Medicines Act 1981, I, G. R. Boyd, Chief Advisor, Regulation and Safety, acting under delegated authority, hereby declare the following: 1. The medicines listed in Schedule 1 to this notice are classified as prescription medicines. 2. The medicines listed in Schedule 2 to this notice are classified as restricted medicines. Every reference to a medicine in this notice applies whether the medicine is synthetic in origin or is from biological or mineral sources. Unless specific reference is made otherwise, every reference applies also to medicines that are: (a) Preparations and admixtures containing any proportion of any substance listed in the notice; (b) Salts and esters of any substance listed in the notice; (c) Preparations or extracts of biological materials listed in the notice; (d) Salts or oxides of elements listed in the notice. Where any reference is modified by a statement of the strength of the medicine, the strength is calculated using the free acid, base, alcohol or element unless specifically stated otherwise. Schedule 1 Prescription Medicines diphenhydramine; in medicines for insomnia or anxiety unless specified elsewhere in this Schedule doxylamine; in medicines for insomnia or anxiety unless specified elsewhere in this Schedule promethazine; in medicines for insomnia or anxiety unless specified elsewhere in this Schedule sildenafil Schedule 2 Restricted Medicines *diphenhydramine; in medicines which are sold in the manufacturer's original pack containing not more than 10 doses for the treatment of insomnia or anxiety *doxylamine; in medicines which are sold in the manufacturer's original pack containing not more than 10 doses for the treatment of insomnia or anxiety *promethazine; in medicines which are sold in the manufacturer's original pack containing not more than 10 doses for the treatment of insomnia or anxiety *Regulation 20 of the Medicines Regulations 1984 requires that all medicines sold without a practitioner's prescription must include a consumer information panel on the label. Further, all material changes to a medicine (including changes to labelling), must be notified to the Director-General of Health in accordance with section 24 of the Medicines Act 1981. Dated this 10th day of November 1998. G. R. BOYD, Chief Advisor, Regulation and Safety.
Publication Date
26 Nov 1998

Notice Number

1998-go8219

Page Number

4490