Applications to register or list medicines or include medical devices in the Australian Register of Therapeutic Goods (ARTG) need an Australian person or company to take legal responsibility for the application and be the official point of contact for TGA.
Companies outside Australia cannot ‘sponsor’ an Australian medicine or medical device. This can create difficulties for a manufacturer who is not yet ready to make formal arrangements with an Australian distributor but wants to get an application underway.
‘JEMPA Sponsor Services Pty Ltd’ (a related company of Archer Emery) was set up to overcome these problems. JEMPA acts as sponsor during the application phase and until such time as the product owner is ready to transfer it to another party.
Act as sponsor for the application while it is in progress through the TGA system;
Sign all documents for the purposes of the product application;
Notify the client promptly of any applicable TGA fees and arrange payment to TGA by the due date;
Notify the client promptly of any communications from TGA relating to the product or the product application;
Notify the client promptly of TGA annual charges or other applicable fees and arrange payment by the due date;
Prepare and submit paperwork for annual fee exemptions where appropriate; and
Transfer the sponsorship of the product to the client’s nominee on request.
JEMPA will charge an annual fee for this service. The client undertakes not to advertise, supply or export the product to Australia while JEMPA remains sponsor.
Where regulatory advice or services are required, these will be provided by Archer Emery & Associates under separate arrangements. All information is held in strict confidence.
Terms and conditions are set out in a separate contract that is available on request.