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Guidance for requesting reconsideration of an initial decision

Version 2.1, January 2017

20 January 2017

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Guidelines

Notification of an initial decision

Under the Therapeutic Goods Act, the Therapeutic Goods Regulations and the Medical Devices Regulations, it is the usual case that notification of an initial decision must be given to a person (usually an applicant or a sponsor) in writing. In some cases, the particulars of an initial decision (such as to cancel a product from the ARTG) must also be published in the Gazette or on the TGA website < www.tga.gov.au > at the time the initial decision is made.

Where written notice of the making of an initial decision is given[1] by the Secretary to a person whose interests are affected by the decision, the notice must inform the person whether the initial decision is a 'reviewable initial' decision which can be reconsidered by the Minister upon request in writing.

Preparing a request for reconsideration

A person whose interests are affected by an initial decision may, by notice in writing given to the Minister, request reconsideration of the initial decision. Such requests must be made:

  • if the Therapeutic Goods Act, the Therapeutic Goods Regulations or the Medical Devices Regulations require the person to be given notice in writing of the initial decision, within 90 days after the notice is given to the person
  • OR
  • in any other case, within 90 days of the publication of the initial decision in the Gazette or on the TGA website OR within 90 days of the decision first coming to the person's notice, whichever is earlier.

Important: A request for reconsideration made after the abovementioned period (i.e. 90 days) cannot be considered by the Minister.

A person whose interests are affected is advised to ensure the notification of a request for reconsideration, includes the following:

  • the notification should be titled '<insert name of person/company> - Request for Reconsideration Under Section 60 of the Therapeutic Goods Act 1989' or '<insert name of person/company> - Request for Reconsideration Under Regulation 48 of the Therapeutic Goods Regulations 1990' or '<insert name of person/company> - Request for Reconsideration Under Regulation 10.7 of the Therapeutic Goods (Medical Devices) Regulations 2002'
  • is dated and signed by the person requesting reconsideration
  • nominates an email address for the purposes of receiving correspondence in relation to the request for reconsideration
  • a copy of the initial decision notification letter (or other evidence of notification)
  • identifies, and describes with as much specificity as possible, which component(s) of the initial decision should be reconsidered and set out the reasons why reconsideration is requested
  • any information/documentation in support of the request, clearly labelled to correspond with (any or each of) the reasons why reconsideration is requested
  • a description of how the person's interests are affected by the initial decision (only applicable if the notification of an initial decision was not issued to the person whose interests are affected).

It is important to ensure all information and documentation that you wish the Minister to consider is provided with your request as the Minister is not able to consider any information provided after the making of a request unless the information is provided in response to a request from the Minister; or (in the case of a review under section 60) the information indicates that the quality, safety or efficacy of therapeutic goods is unacceptable.

Wherever practicable, requests for reconsideration and all supporting documentation should be made available electronically via email, preferably in Adobe (with OCR) format. Requests for reconsideration that include dossiers (or similar bulk material) that cannot easily be attached to the request given first by email, may then be submitted on a USB drive or CD.

Submitting a request for reconsideration

Notification of a request for reconsideration should be given to the Minister by email to:

<> and copied to <>

Requests for reconsideration that include dossiers (or similar bulk material) that cannot easily be attached to the request given first by email, may then be submitted on a USB drive or CD sent by express post or registered mail to:

Minister for Health
Suite M1 40
c/- Parliament House
CANBERRA ACT 2600

Upon receipt of a request for reconsideration of an initial decision, the TGA sends a written acknowledgement to the person who requested the reconsideration to confirm that their request had been received by the Minister's office. The written acknowledgement will:

  • be sent to the email address nominated within the person's request for reconsideration, and
  • advise the latest date by which the outcome of the Minister's decision will be given to the person making the request.

Where the person whose interests are affected is a third party (i.e. the person was not the person to whom the initial decision was issued by the Secretary), the TGA will also notify in writing, the person to whom the initial decision was issued by the Secretary (e.g. the registered sponsor of a product) advising that a request for reconsideration has been received. The registered sponsor of a product for which a request for reconsideration has been made by a third party, will be accorded procedural fairness in the form of a right of reply. The consent of the third party, to release the particulars of their request for reconsideration to the product sponsor, will be sought from the third party before any such right of reply notice is issued by the TGA.

Note:

Where a person who has made a request for reconsideration does not receive notice of the decision of the Minister on that reconsideration within 60 days after making the request[2], the Minister is taken to have confirmed the initial decision.

The Minister needs to consider all the relevant information (including information that was not made available to the Secretary (as the initial decision maker) which is now properly available to consider and to make a decision upon reconsideration that he or she considers is the correct decision in the circumstances. The Minister is not limited to considering issues that were raised in the request for reconsideration, nor is the Minister reviewing the 'lawfulness' of the initial decision of the Secretary or whether the initial decision of the Secretary was right or wrong.

Important:

Under the Therapeutic Goods Act, the Therapeutic Goods Regulations, or the Medical Devices Regulations, the Minister is not able to consider any information that is provided after the making of the request unless the information is provided in response to a request from the Minister; or (in relation to a reconsideration under section 60, the information indicates that the quality, safety or efficacy of therapeutic goods is unacceptable.

Reconsideration by the Minister

The Minister must give notice in writing of the decision upon reconsideration that includes a 'statement of reasons' (i.e. findings, references to evidence and reasons for the decision) to the person whose interests are affected, within 60 days after making a request for reconsideration[3].

If the initial decision is one of which is required to be published in the Gazette or on the TGA website (such as a decision to cancel a product from the ARTG) and the Minister decides to 'revoke' or 'revoke and substitute' the initial decision upon reconsideration, the particulars of the decision upon reconsideration must also be published in the Gazette or on the TGA website.

Subject to the Administrative Appeals Tribunal Act 1975 (the AAT Act), if a person is dissatisfied with a reconsideration decision made by the Minister, an application may be made to the Administrative Appeals Tribunal (AAT) for a review of the Minister's decision by the AAT. Refer to the section titled Administrative Appeals Tribunal.

The Minister may either personally undertake a request for reconsideration of an initial decision or delegate to an officer of the TGA with the appropriate delegation.

A request for reconsideration of an initial decision by the Minister will result in one of the following outcomes:

  • confirm the initial decision
  • revoke the initial decision
  • revoke and substitute the initial decision with a new decision
  • remit the initial decision (Applies to section 60 reconsiderations only. Refer to Section 60A - new information)

Confirm the initial decision

Where the decision upon reconsideration by the Minister is to 'confirm' the initial decision, the Minister has decided to uphold the initial decision. The initial decision therefore remains unchanged.

It is however possible that upon reconsideration, the Minister may have come to the same conclusion as the initial decision of the Secretary but for different reasons. The Minister may assess evidence in support of the decision upon reconsideration differently to the Secretary or come to another conclusion on the basis of available evidence (which might be additional to what was available to the Secretary when making the initial decision).

Revoke the initial decision

Where the decision upon reconsideration by the Minister is to 'revoke' an initial decision (such as to cancel a product from the ARTG), the Minister has decided to overturn the initial decision of the Secretary (i.e. the product should remain on the ARTG). The initial decision is therefore reversed (as though the initial decision was never made).

This may be because the Minister assesses the initial decision of the Secretary as being incorrect at the time it was made and is still incorrect, or as being incorrect only in light of additional information made available to the Minister upon reconsideration of the initial decision.

Revoke and substitute the initial decision with a new decision

Where the decision upon reconsideration by the Minister is to 'revoke and substitute' an initial decision with a new decision, the Minister has decided to vary all or part of the initial decision of the Secretary. The initial decision is therefore partially or entirely replaced (substituted) by a new decision. For instance, the Secretary may have decided not to approve an application. The Minister's decision does not agree - so the Secretary's decision is revoked and the Minister substitutes it with a decision to approve the application.

Upon reconsideration of the initial decision, the Minister may decide that a variation (to one or more specific aspects) of the initial decision of the Secretary is, under certain circumstances, the correct outcome. The Minister may assess the initial decision of the Secretary as being partially or entirely incorrect at the time it was made or as being partially or entirely incorrect in light of additional information made available to the Minister upon reconsideration of the initial decision.

Section 60A - new information on review

Where an initial decision is made by the Secretary under section 25, section 32DF, section 32DG or section 41EC of the Act and a person whose interests are affected by the initial decision, lodges 'new' information in support of a request for reconsideration of the initial decision by the Minister, the Minister must either:

  • take that information into account upon reconsideration of the initial decision
  • OR
  • remit the matter to the Secretary for a fresh decision.

Under the Therapeutic Goods Act, 'new' information means information that was in existence at the time the Secretary made the initial decision under section 25, section 32DF, section 32DG or section 41EC of the Therapeutic Goods Act but was not made available to the Secretary for the purpose of making the initial decision and is information that was relevant to the making of the initial decision.

If the Minister remits the matter to the Secretary and the person whose interests are affected has paid a further evaluation or conformity assessment fee as required under the Therapeutic Goods Act, the Secretary must make a fresh (initial) decision under section 25, section 32DF, section 32DG or section 41EC taking into account the 'new' information, as if a fresh application had been made.

If the Minister decides to remit the request for reconsideration, the Minister must notify their decision in writing to the person whose interests are affected. If the person whose interests are affected does not receive notice in writing of the decision of the Minister to remit the matter within 60 days of the notification of a request for reconsideration being made to the Minister[4], the Minister is taken to have confirmed the initial decision.

Withdrawing a request for reconsideration

The person who made a request for reconsideration of an initial decision can withdraw their request at any time before the reconsideration decision is made by the Minister. Withdrawal of a request for reconsideration should be notified in writing to the Minister as soon as possible.

Notification of the withdrawal of a request for reconsideration should be emailed to <> and copied to <>.


Footnotes

  1. In accordance with section 160 and section 163 of the Evidence Act 1995, written notification of an initial decision via post is deemed to be 'given' to a person within 10 business days after the date of the notice. In accordance with section 14A of the Electronic Transactions Act 1999, written notification via email of an initial decision is deemed to be 'given' to a person within 1 business day after the date that the notice is emailed.
  2. The making of a request for reconsideration is taken to have been made on the date it is received by the Minister.
  3. The making of a request for reconsideration is taken to have been made on the date it is received by the Minister. The Therapeutic Goods Act, the Therapeutic Goods Regulations and the Medical Devices Regulations do not allow for an extension of the 60 day period in which the Minister must reconsider the initial decision.
  4. The making of the (notification) request for reconsideration is taken to have been made on the date it is received by the Minister.

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