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Determinations/Health as made
This instrument identifies those medicines (other than medicines which contain substances included in Schedule 4 or 8 to the current Poisons Standard) that must comply with the mandatory reporting requirements relating to medicines shortages and permanent discontinuations.
Administered by: Health
Registered 07 Dec 2018
Tabling HistoryDate
Tabled HR12-Feb-2019
Tabled Senate12-Feb-2019
Table of contents.

Commonwealth Coat of Arms of Australia

 

Therapeutic Goods (Reportable Medicines) Determination 2018

I, Jane Cook, as delegate of the Minister for Health, make the following determination.

Dated Fifth of December 2018

 

(signed by)

Jane Cook

First Assistant Secretary

Medicines Regulation Division

Department of Health

 

 

 


Contents

1  Name........................................................................................................................................ 1

2  Commencement........................................................................................................................ 1

3  Authority.................................................................................................................................. 1

4  Definitions................................................................................................................................ 1

5  Reportable medicine................................................................................................................. 1

Schedule 1— Reportable medicines                                                                            2

 

 


1  Name

                   This instrument is the Therapeutic Goods (Reportable Medicines) Determination 2018.

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.

 

Commencement information

Column 1

Column 2

Column 3

Provisions

Commencement

Date/Details

1.  The whole of this instrument

1 January 2019.

1 January 2019

Note:          This table relates only to the provisions of this instrument as originally made.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 30EH(2) of the Act.

4  Definitions

Note:          A number of expressions used in this instrument are defined in subsection 3(1) of the Act, including the following:

(a)    medicine;

(b)    registered goods;

(c)    reportable medicine.

                   In this instrument:

Act means the Therapeutic Goods Act 1989.

5  Reportable medicine

                   The medicines set out in Schedule 1, being medicines that are registered goods, are determined to be reportable medicines for the purposes of subparagraph 30EH(1)(b)(ii) of the Act.

                


 

Schedule 1— Reportable medicines

(section 5)

 

Column 1

Item

Column 2

Medicine

1

adrenaline autoinjector

2

glucagon injection

3

glyceryl trinitrate sublingual

4

levonorgestrel

5

monobasic sodium phosphate

6

naloxone  injection

7

naloxone nasal spray

8

salbutamol autohaler

9

salbutamol inhaler

10

terbutaline inhaler

11

ulipristal