The Therapeutic Goods Administration (TGA), an Australian regulating authority in the sphere of healthcare products, has published a guidance document dedicated to the approach to be applied when requesting reconsideration of a regulatory decision. The document provides an overview of the applicable regulatory requirements, allowing an affected party to request a decision be reviewed and reconsidered.
Provisions of the guidance are non-binding in their legal nature, and are not intended to introduce new rules or impose new obligations, but rather to provide additional clarifications and recommendations to be taken into consideration by medical device manufacturers and other parties involved in order to ensure compliance with the existing legal framework
Submitting a Request
The document describes, inter alia, the way the request for reconsideration should be submitted. According to the guidance, such a request should be submitted in electronic form by a party entitled to submit such a request via email. Should it be impossible to submit a request in a single email due to the attachment size, it could be submitted as a set of subsequent emails with the appropriate reference added for ease of navigation.
The authority additionally emphasizes the importance of ensuring that all the emails in the set are dispatched to the authority on the same day. The authority will notify the applicant in writing about the safe receipt of the request. In particular, the said confirmation will:
1. Be sent to the email address nominated in the person’s request for reconsideration, and
2. Advice on the latest date by which the outcome of the Minister’s reconsideration decision will be given to the person making the request.
The authority also mentions that if the response regarding reconsideration was not received by the applicant within 60 calendar days from the date the request was submitted, the initial objection should be considered confirmed by the Minister.
It is important to mention that when submitting a request for reconsideration, an applicant provides all the necessary information related to the matter in order for the authority to be able to assess the details and make a reasonable and justified decision on the merits. Furthermore, any information provided after the submission of the initial request for reconsideration will not be taken into account, unless such information was provided in response to the appropriate request from the authority.
Reconsideration by the Minister
In accordance with the applicable legislation, the Minister may either personally undertake a request for reconsideration of an initial decision or delegate it to an officer of the TGA with the appropriate delegation. As further explained in the guidance, the appropriate response on the matter should be provided by the Minister no later than 60 days from the date the initial request for reconsideration and review was submitted by the applicant.
The response provided will include, inter alia, a justification for the decision taken, and references to the corresponding evidence or other materials on which the was taken based on. As it was mentioned before, the absence of a response from the Minister upon expiration of the aforementioned 60-day period should be construed as confirmation of the initial decision.
When making a decision on reconsideration, the Minister will take into account all the information related to the matter, including the details that were not considered when making the initial decision. The authority further explains that the scope of review will not be limited to the question raised by the applicant. The Minister will not decide whether the initial decision is in line with the applicable legislation but will rather focus on providing a correct decision based on the information and documentation provided by the applicant.
According to the guidance, upon review of the request for reconsideration, the Minister can make a decision to:
1. Confirm the initial decision
2. Revoke the initial decision
3. Revoke and substitute the initial decision with a new one
4. Remit the initial decision (the authority mentions that this option applies to a limited scope of matters).
It is also important to mention that the Minister is entitled to make a decision on matters that haven’t been initially raised by the applicant. According to the guidance, in case of a decision to cancel the product registration is objected to, the Minister may revoke the decision and impose additional conditions that must be fulfilled in order for the registration to be valid.
The document further describes each of the possible outcomes in detail and provides additional clarifications associated with them:
1. Confirming the initial decision -The first option allows the Minister to uphold the initial decision and leave it without changes.
2. Revoke the initial decision. – This option applies in case the Minister decides to overturn the initial decision taken by the Secretary based on the available information. In such a case, the initial decision would be considered to have never taken place.
3. Revoke and substitute the initial decision with a new one. In such a case, in comparison to the previous option, the Minister would not only cancel the initial decision but also issue a new one based on the information provided for review.
Hence, the initial decision would be partially or fully replaced with a new one.
As a general note, the authority also mentions that in the event that the initial decision was officially published, the outcome of the review would be published as well, should it provide that the initial decision be revoked or revoked and substituted.
In summary, the present TGA guidance describes the approach to be applied by an interested party when requesting a regulatory decision be reviewed. The document also provides additional clarifications about the decisions the Minister may take upon such a review and the consequences thereof.
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