Commonwealth legislation

Commonwealth Serum Laboratories Regulations

RepealedCTH

This Act has been repealed and is no longer in force. It is retained for historical reference.

Jurisdiction

Commonwealth

Act Number

7 of 1981

Collection

legislative instrument

Plain English Summary

1/10 complexity

These regulations update outdated 1960s–70s rules to specify six categories of pharmaceutical products Commonwealth Serum Laboratories (CSL) may make, import, or sell — e.g., blood and tissue products, vaccines/micro‑organism products, injectables, antitoxins, immunological agents, and laboratory agents/devices.

They therefore define the legal scope of CSL’s operations and reinforce government oversight of sensitive products like blood derivatives and vaccines.

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Current sections

Direct links to the current provisions in Commonwealth Serum Laboratories Regulations.

Commonwealth Serum Laboratories Regulations

Commonwealth Coat of Arms of Australia

Statutory Rules 1981 No. 71

–––––––

Commonwealth Serum Laboratories Regulations

I, THE GOVERNOR-GENERAL of the Commonwealth of Australia, acting with the advice of the Federal Executive Council, hereby make the following Regulations under the Commonwealth Serum Laboratories Act 1961.

Dated 21 January 1981.

ZELMAN COWEN

Governor-General

By His Excellency’s Command,

MICHAEL MacKELLAR

Minister of State for Health

––––––––––

Citation

These Regulations may be cited as the Commonwealth Serum Laboratories Regulations.

Repeal of former Commonwealth Serum Laboratories Regulations

Statutory Rules 1961 No. 134, 1962 No. 115, 1964 Nos. 86 and 136, 1965 No. 148, 1967 No. 28 and 1969 No. 71 are repealed.

Prescribed classes of pharmaceutical products

The following classes of pharmaceutical products are prescribed for the purposes of paragraph 19 (1) (a) of the Commonwealth Serum Laboratories Act 1961:

(a) agents derived from blood and tissue and synthetic analogues of such agents;

(b) agents derived from micro-organisms and synthetic analogues of such agents;

(d) antitoxic agents;

(e) immunological agents; and

(f) laboratory agents and devices.

NOTE

1. Notified in the Commonwealth of Australia Gazette on 29 January 1981.

Source text

Sourced from the Federal Register of Legislation (legislation.gov.au), CC BY 4.0.

1 Commonwealth Serum Laboratories Regulations

Statutory Rules 1981 No. 71

–––––––

Commonwealth Serum Laboratories Regulations

Dated 21 January 1981.

ZELMAN COWEN

Governor-General

By His Excellency’s Command,

MICHAEL MacKELLAR

Minister of State for Health

––––––––––

Citation

These Regulations may be cited as the Commonwealth Serum Laboratories Regulations.

Repeal of former Commonwealth Serum Laboratories Regulations

Statutory Rules 1961 No. 134, 1962 No. 115, 1964 Nos. 86 and 136, 1965 No. 148, 1967 No. 28 and 1969 No. 71 are repealed.

Prescribed classes of pharmaceutical products

The following classes of pharmaceutical products are prescribed for the purposes of paragraph 19 (1) (a) of the Commonwealth Serum Laboratories Act 1961:

(a) agents derived from blood and tissue and synthetic analogues of such agents;

(b) agents derived from micro-organisms and synthetic analogues of such agents;

(d) antitoxic agents;

(e) immunological agents; and

(f) laboratory agents and devices.

NOTE

1. Notified in the Commonwealth of Australia Gazette on 29 January 1981.