Commonwealth Serum Laboratories Regulations (Cth)

COMMONWEALTH SERUM LABORATORIES REGULATIONS
(#DATE 27:10:1993)

- In force under the Commonwealth Serum Laboratories Act 1961

- Updated as at 27 October 1993
*1* The Commonwealth Serum Laboratories Regulations (in force under the Commonwealth Serum Laboratories Act 1961) as shown in this reprint comprise Statutory Rules 1981 No. 7 amended as indicated in the Tables below.
Table of Statutory Rules
Year and Date of Date of Application
Number Notification commencement saving or
in Gazette transitional
provisions
1981 No. 7 29 Jan 1981 29 Jan 1981
1983 No. 23 28 Feb 1983 28 Feb 1983 -
1984 No. 81 18 May 1984 18 May 1984 -
1986 No. 112 30 May 1986 30 May 1986 -
1989 No. 35 17 Mar 1989 17 Mar 1989 -
Table of Amendments
ad=added or inserted am=amended rep=repealed rs=repealed and substituted
Provision affected How affected
R. 1A ad. 1986 No. 112
R. 3 am. 1983 No. 23
rs. 1984 No. 81
am. 1986 No. 112
R. 4 ad. 1983 No. 23
rep. 1984 No. 81
ad. 1986 No. 112
R. 5 ad. 1986 No. 112
am. 1989 No. 35

COMMONWEALTH SERUM LABORATORIES REGULATIONS - TABLE OF PROVISIONS 
TABLE

                       TABLE OF PROVISIONS

Regulation

    1.    Citation

   1A.    Interpretation

    2.    Repeal of former Commonwealth Serum Laboratories

          Regulations

    3.    Prescribed classes of pharmaceutical products

    4.    Prescribed operations - subparagraph 19 (1) (b) (iiia)

          of the Act

    5.    Prescribed amounts - section 20 of the Act

COMMONWEALTH SERUM LABORATORIES REGULATIONS - REG 1 
Citation 


  1. These Regulations may be cited as the Commonwealth Serum Laboratories
Regulations.*1*
SEE NOTES TO FIRST ARTICLE OF THIS CHAPTER .

COMMONWEALTH SERUM LABORATORIES REGULATIONS - REG 1A 
Interpretation 


  1A. In these Regulations, unless the contrary intention appears, "the Act"
means the Commonwealth Serum Laboratories Act 1961.

COMMONWEALTH SERUM LABORATORIES REGULATIONS - REG 2 
Repeal of former Commonwealth Serum Laboratories Regulations 


  2. 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No. 148, 1967 No. 28 and 1969 No. 71 are repealed.

COMMONWEALTH SERUM LABORATORIES REGULATIONS - REG 3 
Prescribed classes of pharmaceutical products 


  3. The following classes of pharmaceutical products are prescribed for the
purposes of paragraph 19 (1) (a) of the Act:

  (a) pharmaceutical products used in parenteral therapy;

  (b) pharmaceutical products used in non-parenteral therapy;

  (c) laboratory and diagnostic agents and devices.

COMMONWEALTH SERUM LABORATORIES REGULATIONS - REG 4 
Prescribed operations - subparagraph 19 (1) (b) (iiia) of the Act 


  4. For the purposes of subparagraph 19 (1) (b) (iiia) of the Act, the
following operations relating to pharmaceutical products are prescribed:

  (a) exportation and importation;

  (b) purchase, sale and supply;

  (c) specification, design, construction and supply of buildings, plant and
equipment intended for use in connection with research relating to, or the
production of, pharmaceutical products;

  (d) specification and supply of services required in connection with
research relating to, or the production of, pharmaceutical products.

COMMONWEALTH SERUM LABORATORIES REGULATIONS - REG 5 
Prescribed amounts - section 20 of the Act 


  5. (1) For the purposes of paragraph 20 (2) (a) of the Act, an amount of
$3,000,000 is prescribed.
  (2) For the purposes of paragraph 20 (2) (b) of the Act, an amount of
$3,000,000 is prescribed.