Therapeutic Goods (Poisons Standard) (Benzylpenicillin - Seqirus) Exemption 2022

I, John Skerritt, as the appropriate authority, provide the following exemption.

Dated 1 June 2022

Adjunct Professor John Skerritt
Deputy Secretary
Health Products Regulation Group
Department of Health and Aged Care

1 Name

This instrument is the Therapeutic Goods (Poisons Standard) (Benzylpenicillin - Seqirus) Exemption 2022.

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Note: This table relates only to the provisions of this instrument as originally made.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 exemption is provided under section 1.1(3) of Part 2 of the current Poisons Standard.

4 Definitions

Note 1: A number of expressions used in this exemption are defined in subsection (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 exemption are defined in Part 1 of the current Poisons Standard, including the following:
(a) appropriate authority.

In this instrument:

Act means the Therapeutic Goods Act 1989.

specified products means the following medicines that are registered goods:

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

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

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

5 Exemption

1. The requirement in section 1.1(2)(e) of Part 2 of the current Poisons Standard does not apply to a word, expression or statement on a container (which has a capacity of 20 ml or less), or on the label of such a container, of the specified products as the use of letters smaller than 1.5 mm in height is approved.

   Note: Under section 1.1(3)(b) of Part 2 of the current Poisons Standard, the letters on a container, or label of a container, of the specified products must be at least 1 mm in height.

2. The exemption in subsection (1) has effect from the commencement of this instrument until 31 May 2024.