Introduction
This guidance outlines types of variations that have been determined to pose a very low risk. The TGA has concluded that their implementation would not affect the established quality, safety and efficacy of a registered medicine or included biological.
These requests (known as ‘notifications’) still require an application to the TGA. These requests do not require evaluation, but legally must still be approved by the TGA before implementation by the sponsor.
The types of variations that can be submitted as ‘notifications’ are specified in the Therapeutic Goods Regulations 1990 (the Regulations). The conditions for each of these are outlined within the relevant sections below:
- Registered medicines:
- Biologicals.
The descriptions of these types of variations are quite specific. If there is no variation code in the Regulations that describes the intended change, or not all of the conditions outlined in the notifications guidance can be met, then that change cannot be made as a notification and will require approval by the Secretary prior to being implemented.
It is a breach of section 28 of the Therapeutic Goods Act 1989 if a change which requires prior approval from the Secretary is implemented before such approval is given. Penalties may apply if this occurs. Contact the TGA if you are unsure if your change meets the conditions of a notification. General enquiries can be made via the TGA Information line on 1800 020 653 or email info@tga.gov.au and further contact details at www.tga.gov.au/contact-tga.
Notifications process – registered medicines
Sponsors of registered medicines must:
- submit these ‘notification’ requests using the approved electronic form, with any relevant supporting information attached, via the TBS portal.
- provide relevant assurances, which are included in the form, before lodging the application
- pay the appropriate fee.
Once the form is successfully submitted and the fee paid, the sponsor will be sent an email notifying them that the request has been approved and the relevant Australian Register of Therapeutic Goods (ARTG) entry is being automatically updated. This TGA approval is made automatically through the TGA Business Services system for the Secretary under the relevant provisions of the Therapeutic Goods Act 1989.
Notifications process – biologicals
Sponsors of biologicals must:
- submit these ‘notification’ requests using the approved electronic form via the TBS portal
- submit a cover letter and supporting information following our general dossier requirements for all submitted supporting information
- pay the appropriate fee.
After successful submission of the application an approval letter will be manually processed.
A risk-based approach to variations
When applying to register a new medicine or biological, sponsors must submit to the TGA data that assures the quality, safety and efficacy of the good. On the basis of this information, the medicine or biological can be approved by a TGA delegate for registration or inclusion on the ARTG.
Minor variations may be made after goods have been entered on the ARTG. These include, for example, changes to manufacturing processes or updates to product information or labels. Such information would have been relevant at the time the registration decision was made and therefore requests to vary this information must be submitted to the TGA for approval. This helps the TGA to assure the on-going quality, safety and efficacy of the medicine or biological.
Variations to registered medicines and biologicals can range:
- from those that are considered to pose only a very low risk (e.g. ceasing use of a nominated alternative manufacturer)
- to those which may pose a more significant risk (e.g. changes to critical manufacturing methods or proposed extensions to a medicine’s shelf-life).
In some instances, data may also need to be submitted to the TGA for evaluation before the variation can be approved. The TGA therefore takes a risk-based approach to assessing and approving minor variations – from the notification process described above to requests that require careful assessment of technical evidence to confirm that quality, safety and efficacy are being maintained.
Guidance on minor variations
Further information on minor variations and relevant guidance is available on the TGA website: