Federal Register of Legislation - Australian Government

Primary content

Specifications as made
This instrument specifies therapeutic goods information, relating to compliance reviews for listed medicines, that the Secretary may release to the public under section 61 of the Therapeutic Goods Act 1989.
Administered by: Health
Registered 22 Nov 2019
Tabling HistoryDate
Tabled HR25-Nov-2019
Tabled Senate26-Nov-2019
Table of contents.

Commonwealth Coat of Arms of Australia

 

Therapeutic Goods (Listed Medicines¾
Compliance Reviews) Specification 2019

I, John Skerritt, as delegate of the Minister for Health, make the following specification.

Dated 22 November 2019

Adjunct Professor John Skerritt

Deputy Secretary

Health Products Regulation Group

Department of Health

 

 


Contents

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

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

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

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

5  Therapeutic goods information................................................................................................. 2

6  Repeals..................................................................................................................................... 2

Schedule 1—Specified kinds of therapeutic goods information                               3

Schedule 2¾Repeals                                                                                                    6

Therapeutic Goods Information (Outcomes of Compliance Reviews of Listed Complementary Medicines) Specification 2012                                                                                                                                                         6

 

 


1  Name

                   This instrument is the Therapeutic Goods (Listed Medicines¾Compliance Reviews) Specification 2019.

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.

 

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 61(5D) of the Therapeutic Goods Act 1989.

4  Definitions

Note:          A number of expressions used in this instrument are defined in section 3 of the Act, including the following:

(a)    label;

(b)    listing number;

(c)    manufacture;

(d)    medicine;

(e)    Register; and

(f)    Secretary.

                   In this instrument:

Act means the Therapeutic Goods Act 1989.

compliance review, in relation to a listed medicine, means a post-market review carried out by the Therapeutic Goods Administration for the purpose of determining whether certain requirements of the Act, applicable to the medicine, have been, or are being, complied with.

Note:          For example, a compliance review may include verifying the certification made by a relevant sponsor under section 26A or 26AB of the Act in relation to the relevant medicine.

listed medicine means a medicine that is included in the Part of the Register for goods known as listed goods.

Regulations means the Therapeutic Goods Regulations 1990.

relevant medicine means the listed medicine that is the subject of a compliance review.

relevant sponsor means the person in whose name the relevant medicine is listed in the Register.

Therapeutic Goods Administration has the same meaning as in the Regulations.

therapeutic goods information has the meaning given by subsection 61(1) of the Act.

5  Therapeutic goods information

The kinds of therapeutic goods information set out in column 2 of the table in Schedule 1, as described in column 3 of the corresponding item, are specified for the purpose of subsection 61(5C) of the Act.

Note:             Kinds of therapeutic goods information specified under subsection 61(5D) of the Act may be released by the Secretary to the public under subsection 61(5C).

6  Repeals

                   Each instrument that is specified in Schedule 2 is repealed as set out in the applicable items in that Schedule.


 

Schedule 1—Specified kinds of therapeutic goods information

Note:       See section 5.

 

Kinds of  therapeutic goods information

Column 1

Column 2

Column 3

Item

Information                           

Description

1

name of medicine

the name of the relevant medicine

2

listing number

the listing number of the relevant medicine, commonly known as the ARTG ID

3

review outcome

a summary of the outcome of the compliance review in relation to the relevant medicine, including:

(a)     whether the relevant medicine remains listed on the Register and may continue to be supplied; and

(b)     the circumstances in which the relevant medicine may continue to be supplied, including in relation to changes that have been made by the relevant sponsor to address issues identified during the compliance review in relation to the medicine

4

consumer advice in relation to continued use

a recommendation as to whether the relevant medicine is considered safe for continued use by consumers, including:

(a)     the reasons for the recommendation;

(b)     the circumstances in which the use of the relevant medicine is considered safe

5

consumer advice in relation to required action

a recommendation as to the action a consumer of the relevant medicine should take, for example:

(a)     no action;

(b)     reconsidering whether the relevant medicine is right for the consumer;

(c)      seeking medical advice;

(d)     disposing of the relevant medicine;

(e)      contacting the Therapeutic Goods Administration

6

sponsor

the name of the relevant sponsor

7

review type

the type of compliance review carried out in relation to the relevant medicine, as follows:

(a)     random; or

(b)     targeted

8

information reviewed

the type of information reviewed during the compliance review of the relevant medicine, for example:

(a)     the label of the relevant medicine;

(b)     evidence held by the relevant sponsor in relation to the indications of, and claims made for, the relevant medicine;

(c)      documents relating to the manufacture of the relevant medicine;

(d)     promotional and advertising material in relation to the relevant medicine;

(e)      information included in the entry in the Register that relates to the relevant medicine

9

issues relating to safety

a summary of any issues identified during the compliance review that relate to the safety of the relevant medicine, including contraventions of the Act

10

issues relating to efficacy

a summary of any issues identified during the compliance review that relate to the efficacy of the relevant medicine, including contraventions of the Act

11

actions taken during the review

a summary of any relevant actions taken by the relevant sponsor or the Therapeutic Goods Administration during the compliance review of the relevant medicine, for example:

(a)     an update to the listing of the relevant medicine on the Register by the relevant sponsor;

(b)     an update to the label of the relevant medicine by the relevant sponsor;

(c)      a request by the relevant sponsor for the cancellation of the listing of the relevant medicine from the Register following notification of issues;

(d)     a request by the relevant sponsor for the cancellation of the listing of the relevant medicine from the Register following a request for information under section 31 of the Act;

(e)      the cancellation of the listing of the relevant medicine from the Register by the Secretary, where the cancellation was not at the request of the relevant sponsor

12

grounds for cancellation

where applicable, the grounds for the cancellation of the listing of the relevant medicine from the Register

13

date of cancellation

where applicable, the date that the listing of the relevant medicine was cancelled from the Register by the Secretary, where the cancellation was not at the request of the relevant sponsor

14

date of review outcome

the date that the outcome of the compliance review was notified to the relevant sponsor by the Therapeutic Goods Administration, being the date that the compliance review was concluded

15

date of publication

the date that the information in relation to the compliance review of the relevant medicine was published on the Therapeutic Goods Administration’s website

16

additional information

details of any relevant information, actions taken, or decisions made, in relation to the relevant medicine after the conclusion of the compliance review


 

Schedule 2¾Repeals

Note:       See section 6.

Therapeutic Goods Information (Outcomes of Compliance Reviews of Listed Complementary Medicines) Specification 2012

1  The whole of the instrument

Repeal the instrument.