Therapeutic Goods (Poisons Standard) (Benzylpenicillin—Seqirus) Approval 2024

I, Anthony Lawler, as the appropriate authority, provide the following exemption.

Dated 31 May 2024

Professor Anthony Lawler
Deputy Secretary
Health Products Regulation Group
Department of Health and Aged Care

1 Name

This instrument is the Therapeutic Goods (Poisons Standard) (Benzylpenicillin - Seqirus) 
Approval 2024.

2 Commencement

1. Each provision of this instrument specified in column 1 of the table commences, or is taken to have commenced, in accordance with column 2 of the table. Any other statement in column 2 has effect according to its terms.

Note: This table relates only to the provisions of this instrument as originally made. It will not be amended to deal with any later amendments of this instrument.

2. Any information in column 3 of the table is not part of this instrument. Information may be inserted in this column, or information in it may be edited, in any published version of this instrument.

3 Authority

This instrument is made under subsection 13(3) of the current Poisons Standard.

4 Definitions

Note 1: A number of expressions used in this instrument are defined in subsection 3(1) of the Act, including the following:
(a) container;
(b) current Poisons Standard;
(c) medicine;
(d) registered goods;
(e) registration number.

Note 2: A number of expressions used in this instrument are defined in section 6 of the current              Poisons Standard, including the following:
            (a)   appropriate authority

In this instrument:

Act means the Therapeutic Goods Act 1989.

specified goods means the following medicines that are registered goods:

(a) BENPEN benzylpenicillin (as sodium) 1.2 g powder for injection vial, registration number 10326;

(b) BENPEN benzylpenicillin (as sodium) 3 g powder for injection vial, registration number 10327;

(c) BENPEN benzylpenicillin (as sodium) 600 mg powder for injection vial, registration number 10329.

5 Approval

1. The requirement in paragraph 13(2)(e) of the current Poisons Standard does not apply to a word, expression or statement on, or on the label of, a container of the specified goods which has a capacity of 20 mL or less, as the use of letters smaller than 1.5 mm in height is approved.

   Note: Under paragraph 13(3)(b) of the current Poisons Standard, the letters on a container, or label of a container, of the specified goods must still be at least 1 mm in height.

2. The approval in subsection (1) remains in force until 31 October 2028.

6 Repeals

1.         Unless repealed earlier, this instrument is repealed at the start of  1 November 2028.

2.         This instrument repeals the Therapeutic Goods (Poisons Standard) (Benzylpenicillin—Seqirus) Exemption 2022.