EXPLANATORY STATEMENT
STATUTORY RULES 1983 NO. 23
COMMONWEALTH SERUM LABORATORIES ACT 1961
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) in respect of prescribed pharmaceutical products, or pharmaceutical products included in prescribed classes of pharmaceutical products, may produce, buy, import, supply, sell or export such products and conduct research in relation to such products.
CSL regulations prescribe certain classes of pharmaceutical products in accordance with paragraph 19(1)(a) of the Act. CSL were offered the distribution rights of a range of pharmaceutical products, a number of which were not covered by the existing regulations. Consequently, the regulations were amended to provide for the introduction of a limited number of specific products that would allow CSL to take advantage of commercial opportunities to improve the viability of its operations and increase the financial return to the Commonwealth.