In 2017, the TGA introduced the 'notifications' process for very low risk changes to biologicals and to registered medicines. This process was implemented in two stages:
- notifications to registered non-prescription medicines launched in July 2017
- notifications to biologicals and prescription medicines launched in December 2017.
The notifications process is part of our improved risk-based approach to the management of variations and was implemented in response to recommendations arising from the Review of Medicines and Medical Devices Regulation (MMDR).
The process for registered medicines
Under the notifications process, an applicant uses an electronic form to request certain types of changes to registered medicines. As part of this request, the applicant is required to make legal assurances that all 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 applicant can then make these changes to their medicine.
Note: Manual processing and approval is still required for notifications to biologicals.
Ensuring all conditions and data requirements are met when submitting notification applications
Through 2020-22, a range of applications submitted as notifications for prescription medicine chemical entities were reviewed to ensure compliance with the conditions specific to the variation and data requirements were met.
The review highlighted that the description, conditions and data requirements for some notification application types are not clearly understood.
In particular, there is a lack of clarity about the following notification variation types:
- ACEP: API Certificate of Suitability (CEP) - A revision for a non-sterile API that is not a synthetic polypeptide or prepared by fermentation
- AMTA: API site of manufacture - transfer of/addition to an existing manufacturer's site of a non-sterile API that is not prepared by fermentation
- DMES: Drug product manufacture - changes to manufacturing method and/or equipment for solid dosage forms that are not modified release
- DSPT: Drug product specification - changes resulting from pharmacopeial or TGO requirements.
To assist your understanding, the TGA will continue ongoing reviews of applications submitted as notifications. Through this process, applicants may receive direct communication from the TGA regarding any deficiencies in submissions. This may include advice to improve compliance with the conditions and data requirements in future submissions, or a request for further information or data. In some cases, applicants may receive a proposal to substitute the decision, or other compliance actions.
The TGA will be collecting data from this process and using it to improve guidance material. This will help ensure applications submitted as notifications are fully compliant with all regulatory requirements.
For questions regarding whether a proposed variation meets the description, conditions and data requirements of certain notification codes, please contact PCSinbox@health.gov.au.
Bundling changes into one application
Making a variation to many aspects of a medicine can result in applicants making multiple applications across multiple categories. For example, Notifications, Self-Assessable Requests (SAR) and Category 3 (Cat 3) variation applications.
Selecting a separate variation type for each of these changes will result in multiple applications and additional fees. However, in some cases multiple changes can be considered as a consolidated package under a single submission. For example, under a single Category 3 submission. This will save administrative effort and application costs.
Section 4.1 of the process guidance below provides more information on submitting multiple related and unrelated changes, including specific examples to assist you.
Guidance
Guidance on the prescription medicines notification process and the types of changes allowed to be notified is provided below.
Further information
Further information and guidance on minor variations is available at: