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Approval of PI form

3 April 2018

A new form for providing product information (PI) was approved on 8 November 2017, with a commencement date of 1 January 2018. The new format is being implemented over a 3-year transition period, ending on 31 December 2020. PIs accompanying applications submitted under section 23 of the Therapeutic Goods Act 1989.(the Act) must comply with the new format. PIs may be submitted in the new format with applications seeking to vary an ARTG entry under Section 9D of the Act.

A revised version of this form was approved on 8 March 2018 following amendments to the Act. The revised version includes updated references to the Act as well as updates to the form to improve its clarity and provide some additional instructions. The Reformatting Product Information - Frequently asked questions page has been updated to provide more detailed advice on these changes.

Instrument of Approval

Approved form for product information in relation to medicine under subsection 7D(1) of the Therapeutic Goods Act 1989

I, Larry Kelly, First Assistant Secretary of the Medicines Regulation Division and delegate of the Secretary of the Department of Health for the purposes of section 7D of the Therapeutic Goods Act 1989 ("the Act"):

REVOKE any previous approvals made under subsection 7D(1) of the Act; and

APPROVE under subsection 7D(1) of the Act, in relation to medicine, the form in Schedule 1 to this instrument to be the form in which product information must be given to the Secretary with:

  1. an application for the registration of a restricted medicine in accordance with paragraph 23B(2)(e) of the Act;
  2. an application for the registration of any other medicine for which the Secretary has given notice that product information is to be provided in accordance with subparagraph 25(1)(da)(ii) of the Act;
  3. a response to a written notice of the Secretary requiring product information to be given under subsection 25AA(1B) of the Act; and
  4. a request to vary an entry in the Register under section 9D of the Act, in relation to a medicine, which would result in a variation to approved product information in accordance with paragraph 25AA(4)(c) of the Act.

COMMENCEMENT

This approval commences on 9 March 2018 ("the commencement").

TRANSITIONAL ARRANGEMENTS

This approval is subject to the following arrangements.

In this instrument –

an earlier approved form, in relation to product information, means a form approved in an instrument of approval made under subsection 7D(1) of the Act, including those approved on 12 May 2011 and 8 November 2017, as in force before the commencement of this instrument.

restricted medicine means the classes of medicines mentioned in Schedule 1 to the Restricted Medicine Specification 2011.

transition period means the period beginning on the commencement of this instrument and ending on 31 December 2020.

For the duration of the transition period, product information accompanying a request to vary an entry in the Register mentioned in paragraph (c) of this instrument, which is given to the Secretary in accordance with an earlier approved form, is taken to have been given in accordance with the approved form in Schedule 1 to this instrument.

INTERPRETATION

In this instrument and the approved form in Schedule 1 to this instrument –

ARTG is taken to mean the Register as defined in section 3 of the Act.

Australian Approved Name, in relation to a therapeutically active ingredient, means the name of that ingredient in the Australian Approved Names List – being a document defined in section 2 of the Therapeutic Goods Regulations 1990 entitled Australian Approved Names List for Therapeutic Substances, as in force from time to time, and published by the Therapeutic Goods Administration.

date of first approval is taken to mean the date on which the Secretary included the medicine in the Register in accordance with paragraph 25AB(1)(e) of the Act.

date of revision is taken to mean, in relation to a medicine, the date on which the Secretary:

  1. provides notice to a person under subsection 25AA(4) of the Act that it is appropriate to vary the product information approved in relation to that medicine as a result of a variation to the relevant entry under section 9D of the Act; or
  2. approves product information under subsection 25AA(1) of the Act following a decision to register that medicine under subsection 25(3) of the Act, where the medicine is part of an existing gazetted therapeutic goods group determined by the Secretary under subsection 16(2) of the Act.

excipient has the same meaning as given in the Therapeutic Goods Order No. 91 – Standard for labels of prescription and related medicines.

gazetted therapeutic goods group has the same meaning as given in section 3 of the Act.

Poisons Standard is taken to mean the current Poisons Standard as defined in section 3 of the Act.

therapeutic indications is taken to mean indications as defined in section 3 of the Act.

Note A number of expressions used in this instrument and the approved form in Schedule 1 to this instrument are defined in the Act, including the following:

  1. container;
  2. dosage form;
  3. indications;
  4. medicine;
  5. presentation;
  6. product information;
  7. Register;
  8. restricted medicine;
  9. sponsor; and
  10. standard.

All headings, and information of the kind specified as mandatory standard text, in the approved form in Schedule 1 to this instrument must be included in product information unless indicated otherwise in the approved form.

To avoid any doubt, the information provided in the substantive dot points and the notes to the approved form in Schedule 1 to this instrument is provided to assist with the interpretation of the approved form, and is not intended to be reproduced in product information unless otherwise indicated.

LARRY KELLY
Delegate of the Secretary
8 March 2018