Federal Register of Legislation - Australian Government

Primary content

Regulations as made
This instrument amends the Therapeutic Goods Regulations 1990 to introduce an exemption from the operation of Part 3-3 of the Therapeutic Goods Act 1989 for certain radiopharmaceuticals and radiopharmaceutical active ingredients.
Administered by: Health
Registered 01 May 2020
Tabling HistoryDate
Tabled HR12-May-2020
Tabled Senate12-May-2020
To be repealed 13 Aug 2020
Repealed by Division 1 of Part 3 of Chapter 3 of the Legislation Act 2003
Table of contents.

Commonwealth Coat of Arms of Australia

 

Therapeutic Goods Amendment (Radiopharmaceuticals and Radiopharmaceutical Active Ingredients) Regulations 2020

I, General the Honourable David Hurley AC DSC (Retd), Governor‑General of the Commonwealth of Australia, acting with the advice of the Federal Executive Council, make the following regulations.

Dated 30 April 2020

David Hurley

Governor‑General

By His Excellency’s Command

Greg Hunt

Minister for Health

 

 

 

  

  


Contents

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

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

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

4............ Schedules...................................................................................................................... 1

Schedule 1—Amendments                                                                                                                          2

Therapeutic Goods Regulations 1990                                                                                               2

 


1  Name

                   This instrument is the Therapeutic Goods Amendment (Radiopharmaceuticals and Radiopharmaceutical Active Ingredients) Regulations 2020.

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

The day after this instrument is registered.

2 May 2020

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 the Therapeutic Goods Act 1989.

4  Schedules

                   Each instrument that is specified in a Schedule to this instrument is amended or repealed as set out in the applicable items in the Schedule concerned, and any other item in a Schedule to this instrument has effect according to its terms.

Schedule 1Amendments

  

Therapeutic Goods Regulations 1990

1  Schedule 7 (at the end of the table)

Add:

 

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radiopharmaceuticals if:

(a) the radiopharmaceuticals are manufactured by:

(i) a medical practitioner registered under a law of a State or Territory when employed by a public or private hospital or a public institution, or a person under the professional supervision of such a medical practitioner; or

(ii) a radiochemist when employed by a public or private hospital or a public institution, or a person under the professional supervision of such a radiochemist; or

(iii) a pharmacist registered under a law of a State or Territory when employed by a public or private hospital or a public institution, or a person under the professional supervision of such a pharmacist; and

(b) the radiopharmaceuticals are for supply to another public or private hospital, another public institution or a private institution within Australia for the purposes of:

(i) diagnosing a medical condition in respect of a patient of the hospital or institution; or

(ii) treating a medical condition of a patient of the hospital or institution

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radiopharmaceutical active ingredients if:

(a) the ingredients are manufactured by:

(i) a medical practitioner registered under a law of a State or Territory when employed by a public or private hospital or a public institution, or a person under the professional supervision of such a medical practitioner; or

(ii) a radiochemist when employed by a public or private hospital or a public institution, or a person under the professional supervision of such a radiochemist; or

(iii) a pharmacist registered under a law of a State or Territory when employed by a public or private hospital or a public institution, or a person under the professional supervision of such a pharmacist; and

(b) the ingredients are for supply to another public or private hospital, another public institution or a private institution within Australia, which are then used by the hospital or institution to manufacture a radiopharmaceutical for the purposes of:

(i) diagnosing a medical condition in respect of a patient of the hospital or institution; or

(ii) treating a medical condition of a patient of the hospital or institution