Therapeutic Goods (Prescription Medicines—Information Accompanying Applications for Registration) Determination 2021

I, Jane Cook, as delegate of the Secretary of the Department of Health, make the following determination.

Dated 27 October 2021

Dr Jane Cook

Contents

1  Name

2  Commencement

3  Authority

4  Definitions

5  Application

6  Form of information

Schedule 1—Prescription Medicines

1  Name

  This instrument is the Therapeutic Goods (Prescription Medicines—Information Accompanying Applications for Registration) Determination 2021.

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Note: This table relates only to the provisions of this instrument as originally made.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 instrument is made under subsection 23B(10) of the Therapeutic Goods Act 1989.

4  Definitions

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

(a) biological;

(b) medicine;

(c) Register;

(d) registered goods.

  In this instrument:

Act means the Therapeutic Goods Act 1989.

biosimilar means a medicine that is a biosimilar in relation to a registered medicine.

eCTD means the electronic Common Technical Document standard format in accordance with the Australian regional specification.

extension of indications medicine means a medicine that:

 (a) contains the same chemical, biological or radiopharmaceutical active ingredient (or fixed combination of such ingredients) as another medicine included in the Register; and

 (b) has one or more indications in addition to that other medicine.

generic product has the same meaning as in the Regulations.

major variation has the same meaning as in clause 1 of Schedule 9 to the Regulations.

major variation medicine means a medicine that is taken to be separate and distinct from a registered medicine because of a major variation but does not include:

 (a) a new chemical entity medicine; or

 (b) a new biological entity medicine; or

 (c) a new biosimilar medicine; or

 (d) a new combination medicine; or

 (e) an extension of indications medicine; or

 (f) a new generic medicine; or

 (g) a new trade name medicine.

new biological entity medicine means a medicine that:

 (a) has not previously been included in the Register, and contains a biological substance; or

 (b) contains a biological substance mentioned in paragraph (c) of the definition of new chemical entity.

new biosimilar medicine means a medicine that has not previously been included in the Register and is a biosimilar in relation to a registered medicine.

new chemical entity has the same meaning as in clause 1 of Part 1 of Schedule 9 to the Regulations.

new chemical entity medicine means a medicine that contains a new chemical entity as mentioned in paragraphs (a), (b) and (d) of the definition of new chemical entity.

new combination medicine means a medicine that contains a new chemical entity as mentioned in paragraph (e) of the definition of new chemical entity.

new generic medicine means a medicine that has not previously been included in the Register and is a generic product.

new trade name medicine means a medicine that:

 (a) has the same active ingredient or active ingredients (or fixed combination of active ingredients) as a registered medicine; and

 (b) has the same indications as that other medicine; and

 (c) has the same dosage form as that other medicine; and

 (d) has been given a different name to that other medicine by the manufacturer, under which the medicine will be supplied.

registered medicine means a medicine that is included in the part of the Register for goods known as registered goods.

Regulations means the Therapeutic Goods Regulations 1990.

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

5  Application

  This instrument applies to medicines of the class specified in paragraph 4(1)(a) of the Therapeutic Goods (Classes of Therapeutic Goods) Instrument 2018.

Note: The Therapeutic Goods (Classes of Therapeutic Goods) Instrument 2018 is a notifiable instrument and is published on the Federal Register of Legislation at www.legislation.gov.au.

6  Form of information

  For the purposes of subparagraph 23B(2)(d)(ii) of the Act, the information in an application dossier, that accompanies an application for the registration of a medicine mentioned in Schedule 1, must be in:

 (a) the eCTD format; or

 (b) if exceptional circumstances exist—another format with the prior written agreement of the Therapeutic Goods Administration.

Schedule 1—Prescription Medicines

Note: See section 6.