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New process for lodgement of applications for new registered complementary medicines
The introduction of the TGA eBusiness Services (eBS) has provided sponsors of many therapeutic goods with a platform for the electronic lodgement of applications for entry of goods on the Australian Register of Therapeutic Goods (ARTG). However, until now, there has been no such mechanism for new registered complementary medicine (CM) applications and these have continued to be paper-based.
To address this administrative deficiency, the Complementary Medicines Branch has arranged for the online application system currently used for registered over-the-counter medicines to accept applications for new registered CMs. Most potential sponsors of a new registered CM would be familiar with this system - the OTC Medicines Electronic Lodgement system (OPAL).
Accordingly, the paper-based application form for a new registered CM has been removed from the TGA website and replaced with a link to the eBS portal. The submission of the data dossier remains the same; the applicant is still required to submit a hard copy of the dossier to the Complementary Medicines Branch.
Please note that applications for variations to registered CMs and those for new listable CM substances will both continue to be paper-based.
Lodging an application for a new registered CM
- Before making an electronic application, the applicant must notify the Complementary Medicines Branch (by letter or email; for contact details see Contact details for enquiries about complementary medicines) of the intention to lodge the application. This should occur a week or two before making an online application. No paper documentation needs to be submitted at this stage.
- The applicant makes the electronic application through the eBS portal. An invoice is raised once the application has been submitted.
- The applicant should then submit a hard copy of the data dossier to the Complementary Medicines Branch.
- Once the invoiced fees have been paid, a pre-evaluation assessment of the dossier will commence. The applicant will be notified in writing by the Complementary Medicines Branch regarding the acceptance or otherwise of the application (as per the current process). The evaluation process will commence as soon as the submitted information is considered satisfactory and all fees are paid in full.
- Once the evaluation process is completed, and provided that the product is approved, an approval letter is sent to the sponsor requesting relevant documentation (Section 26B certificate) before the product can be entered on the ARTG.
- Following the receipt of required information, the application is finalised online by the Complementary Medicines Branch. The sponsor is asked to verify if all details of the application are correct. Once the product has been entered on the ARTG, the Registration Certificate will be available online for printing by the sponsor.