Business process review: minor variations to prescription medicines - for sponsors

23 August 2013

On 22 May 2013, the TGA introduced changes to administrative processes for making minor variations to prescription medicines. These changes are now fully implemented.

The new processes apply to variations of the following kinds to an entry of a prescription medicine in the Australian Register of Therapeutic Goods (ARTG):

  • corrections to the entry
  • safety-related variations
  • minor editorial changes to the Product Information (PI)
  • 'self-assessable' variations
  • Category 3 quality-related changes.

These minor variations are made under section 9D of the Therapeutic Goods Act 1989.

Background

The sponsor of a registered prescription medicine may wish to make certain minor variations to the entry of the medicine in the ARTG.

To implement a more effective process, the TGA reviewed how these variations are made. A report on the outcomes of the review was published on 24 September 2012.

The review identified the need for several changes to processes; to be consistent with legislation and regulatory requirements.

Implementation of the changes to business processes

As part of the outcomes of the review, the TGA has, in consultation with industry:

  • updated guidance documents to help sponsors prepare requests and applications for submission to the TGA
  • created new forms for making requests and applications for minor variations.

Sponsors should also note the following:

  • prior TGA approval is required for all new minor variations
  • the TGA will process all new self-assessable requests (SARs), minor editorial changes to the PI and Category 3 applications in 45 working days
  • new safety-related requests requiring TGA evaluation of data will be processed as minor variations and the relevant fee category will be applied.

A summary of the processes is provided below.

Updated guidance documents

The following guidance is available to help sponsors to prepare requests and applications for submission to the TGA:

Communication activities

The TGA has undertaken a number of activities to communicate the outcomes of the review of minor variations to prescription medicines to sponsors.

Enquiries

Specific enquiries about applications for minor variations in progress should be made by contacting the TGA.

Summary of revised processes and guidance

The following table below describes the revised business processes for making minor variations to prescription medicines, including the arrangements during the transition period.

Request type Form@ Process Processing timeframe* Guidance#

Correction to an ARTG entry

section 9D(1)

Request to correct an ARTG entry under
subsection 9D(1)
Prior approval required before any corrections are made to ARTG entries (including corrections to ARTG entries resulting in an amendment to PI documents) None Part 2

Safety-related request
(without data)

section 9D(2)

Safety-related variation: Request to vary an ARTG entry under
subsection 9D(2)
Prior approval required before any changes are made to PI documents None Part 3

Safety-related request
(with data)

section 9D(2)

Safety-related variation: Request to vary an ARTG entry under
subsection 9D(2)

Prior approval required before any changes are made to PI documents

All proposed changes that meet the criteria of s. 9D(2), but require evaluation of data by the TGA, should be submitted under this process

None Part 3

Minor editorial change to the PI (MEC)

Self-assessable request (SAR)

section 9D(3)

Self-assessable request: Request to vary an ARTG entry under
subsection 9D(3)
Prior approval required before any changes are made to products (including changes to PI documents) 45 working days (wd)

Part 1 (MECs)

Part 4 (SARs)

SAR

section 23

Self-assessable request: Quality-related variation under section 23 Prior approval required before any changes are made to products (including changes to PI documents) 45 wd Part 5

Category 3 application

section 9D(3)

Category 3 application: Request to vary an ARTG entry under
subsection 9D(3)
No change 45 wd Part 4

Category 3 application

section 23

Category 3 application: Quality-related variation under section 23 No change 45 wd Part 5