Proposed new notifications process: registered medicines

2 November 2017

As identified in the Review of Medicines and Medical Devices Regulation (MMDR), we are improving our risk-based approach to the management of variations to registered medicines.

A key improvement is the introduction of a 'notifications' process for very low risk changes to all registered medicines. This implementation commenced in July 2017 with further improvements to be launched before the end of the year.

The process

Under the notifications process, an applicant uses an electronic form to request that certain types of changes be made to their medicines. As part of this request, the applicant will be required to make legal assurances that all of the conditions specific to the variation are met.

Once the relevant fee is paid, the request is automatically processed:

  • the change is approved
  • an acknowledgement letter is sent and
  • the affected ARTG entries updated.

The sponsor can then make these changes to their medicine.

Guidance

Guidance on the notification process and the types of changes allowed to be notified is provided below.

Implementation timeframes

Below are the implementation timeframes, subject to the finalisation of legislative changes:

Activity Timing
Automated notification process implemented for registered non-prescription medicines (initial set of notifications)

Launched
1 July 2017

The new e-form for minor variations to prescription medicines is available through the TBS portal.

Launched
July 2017

Prescription medicines: Automated notification process implemented for prescription medicines and improvements to the general functionality of the e-form.

Non-prescription medicines: Second set of notifications implemented for registered non-prescription medicines (pending legislative changes).

4 December 2017
(IT deployment 1-3 December)

During the IT deployment window – what you need to do

We plan to update the online application forms between 1-3 December 2017.

Prescription medicines

Before 1 December 2017:

  • Either submit or delete any draft applications that include a code that will become a notification. Submission of these drafts after 1 December will result in an error message and a new application will need to be created.

Between 1-3 December 2017:

  • Do not use the minor variations e-form to submit a new application or edit an existing draft application.

Non-prescription medicines

Between 2-3 December 2017:

  • Do not use the OTC portal to submit a new application or edit an existing draft OTC/RCM application.

Legislative changes

The Therapeutic Goods Regulations 1990 (the Regulations) set out the types of variations that are processed as notifications.

Initial set of notifications

For registered non-prescription medicines (OTC and registered complementary medicines), these came into effect from 1 July 2017.

Notifications to prescription medicines (biological medicines and chemical entities) will commence once the new e-form for minor variation applications allows automated electronic processing of these variation types (planned from 4 December 2017).

Additional set of notifications

Since 1 July 2017, additional changes that could be processed as notifications have been proposed for both prescription and non-prescription medicines. These need to be included in the Regulations before they can be implemented.

Variations guidance

Further information and guidance on variations to registered medicines is available at: