EXPLANATORY STATEMENT
STATUTORY RULES 1984 NO. 81
COMMONWEALTH SERUM LABORATORIES REGULATIONS (AMENDMENT)
Issued by the authority of the Minister for Health
Section 45 of the Commonwealth Serum Laboratories Act 1961 (‘the Act’) provides that the Governor-General may make regulations, not inconsistent with the Act, prescribing all matters required or permitted by the Act to be prescribed, or necessary or convenient to be prescribed for carrying out or giving effect to the Act.
Paragraph 19(1)(a) of the Act provides that the Commonwealth Serum Laboratories Commission (CSL) may, in respect of prescribed pharmaceutical products, or pharmaceutical products included in prescribed classes of pharmaceutical products, produce, buy, import, supply, sell or export such products and conduct research in relation to such products.
Regulations 3 and 4 of the Commonwealth Serum Laboratories Regulations (‘the Regulations’) prescribe certain classes of pharmaceutical products and individual pharmaceutical products for the purposes of paragraph 19(1)(a) of the Act.
The regulations repealed existing regulations 3 and 4 and substituted a new regulation 3 which provides that, for the purposes of paragraph 19(1)(a) of the Act, prescribed classes of pharmaceutical products are:
• those used in parenteral therapy;
• those used in non-parenteral therapy;
• laboratory and diagnostic agents and devices
The prescribing of pharmaceutical products used in parenteral and non-parenteral therapy ensures that all products introduced into or used on a human body or animal are covered by the Regulations. The terms ‘parenteral’ and ‘non-parenteral’ refer to the form of administration to the body of a particular pharmaceutical product: ‘non-parenteral’ therapy is via the alimentary tract, while ‘parenteral’ therapy encompasses all other forms of administration, that is, subcutaneous, intravenous, intramuscular or intrasternal.
The prescribing of laboratory and diagnostic agents and devices as pharmaceutical products under the Act ensures that the testing of any substance, such as blood, after it is removed from the body by such agents and devices is also covered by the Regulations.
In accordance with sub-section 19(1) of the Act, CSL is obliged to conduct its operations as a business, and, accordingly, to pursue a policy directed towards profit-making. The Regulations assist CSL in complying with the provisions of the Act by allowing it greater access to the human, veterinary and diagnostic pharmaceutical markets in which it exercises its statutory functions.