Medicines Amendment Act (No 2) 2003

1: Title
1: This Act is the Medicines Amendment Act (No 2) 2003.
2: In this Act, the Medicines Act 1981 the principal Act
2: Commencement
This Act comes into force on 30 October 2003.
3: Interpretation
Section 2(1) ERMA Hazardous Substances and New Organisms Act 1996 new organism section 2A Hazardous Substances and New Organisms Act 1996 qualifying new medicine
a: is or contains a new organism; and
b: meets the criteria set out in section 38I(3) Hazardous Substances and New Organisms Act 1996 qualifying organism
4: New
section 5A The principal Act is amended by inserting, after section 5
5A: Relationship with
Hazardous Substances and New Organisms Act 1996 In relation to medicines that are or contain hazardous substances or new organisms, the requirements of this Act are additional to the requirements of the Hazardous Substances and New Organisms Act 1996
5: New
sections 24A to 24G The principal Act is amended by inserting, after section 24 Qualifying new medicines
24A: Assessment of qualifying new medicines
The Director-General may grant an approval under section 38I of the Hazardous Substances and New Organisms Act 1996
a: has the consent of the Minister to do so; and
b: is acting under a delegation from ERMA given under section 19 of that Act
24B: Procedure if Director-General declines to grant approval
If the Director-General declines to grant an approval because the new organism is not a qualifying new medicine, then—
a: the Director-General must—
i: inform ERMA that the new medicine is not a qualifying new medicine; and
ii: provide ERMA with a copy of all information (from assessing the safety, quality, and efficacy of the new medicine) that the Director-General considers may assist ERMA in deciding whether to approve or decline the application under the Hazardous Substances and New Organisms Act 1996
b: the Minister must not consent under section 20 section 23 Hazardous Substances and New Organisms Act 1996 Approval of medicines required for use in special emergency
24C: Interpretation
In sections 24D to 24G hazardous substance section 2(1) of the Hazardous Substances and New Organisms Act 1996 responsible Minister section 49A of the Hazardous Substances and New Organisms Act 1996 special emergency section 49A of the Hazardous Substances and New Organisms Act 1996
24D: Approval of medicines required for use in special emergency
1: An application may be made to the Minister for approval to distribute, sell, or advertise in a special emergency a medicine that is or contains a hazardous substance or new organism.
2: The Minister may approve an application under subsection (1)
a: the special emergency has been declared and has not come to an end; and
b: the medicine is required for the special emergency; and
c: the application complies with subsection (3)
3: An application under subsection (1)
a: be accompanied by the prescribed application fee (if any); and
b: be in a form approved by the Director-General; and
c: be accompanied by any information that the Minister considers is necessary for determining whether or not to approve the application.
24E: Notification or publication of approval
The approval of an application under section 24D Gazette
24F: Duration of approval
An approval of an application under section 24D
a: the date of expiry (if any) of the special emergency specified by the responsible Minister in—
i: the declaration declaring the special emergency; or
ii: a later declaration declaring that the special emergency has ceased; or
b: the date of expiry (if any) specified by the responsible Minister in the approval, which must not be later than the date of expiry of the special emergency; or
c: if paragraph (a) or paragraph (b)
24G: Consequences of expiry of approval
On the expiry of an approval of an application under section 24D