New product applications to the TGA or Medsafe

Some products need to be fully evaluated by TGA / Medsafe ('registered' products) while others can be self-assessed ('listed' products).

Information can be found on the TGA and Medsafe web sites but it is difficult to put together a successful application without experience and professional advice. Fees can be substantial and are usually not refunded, even if the application is rejected. Many applications are rejected or have long delays because they have not been properly put together.

Engaging Archer Emery and Associates as a consultant can be very cost-effective. In a short time we can tell you the classification of your product, the data and information you will need, the cost of the application and give you an opinion on the likelihood of the application being approved. We can either help you to prepare an application or prepare and lodge it on your behalf.

In the course of the evaluation, the agency may ask technical questions about the submitted data and request further information or data. We can help you respond appropriately or deal directly with the agency on your behalf.

Sometimes applications are not successful. In these cases you are entitled to appeal to the Australian Health Minister and, if this is not successful, to the Administrative Appeals Tribunal. We can help by reviewing your submission and the reasons for rejection and providing advice on possible grounds for appeal.

Our expertise will save you time and money and increase your chance of success.

Contact us for more information.



Next : Variation applications to the TGA or Medsafe