The Therapeutic Goods Administration (TGA) regulates medicines and medical devices in Australia. There are different categories of applications for prescription medicines - Category 1 involves new drugs or changes requiring clinical data review, Category 2 involves identical drugs already approved in other countries, and Category 3 involves quality changes only. Applications are processed within statutory timeframes, and variations to approved drugs can be major requiring full review, or minor involving low-risk changes with streamlined processes. Fees are charged depending on the type and complexity of the application or variation.

1. Australia – Types of
Applications & Variations
(Prescription Medicines)
By
Charan Karumuri
Executive – I
Regulatory Affairs
Lyrus Life Sciences

2. About the Therapeutic GoodsAdministration (TGA)
 The TGA is a division of the Australian Government Department of Health and Ageing, and is responsible for regulating medicines and
medical devices.
 TGA administers the Therapeutic Goods Act 1989 (the Act), applying a risk management approach designed to ensure therapeutic goods
supplied in Australia meet acceptable standards of quality, safety and efficacy (performance), when necessary.
 The work of the TGA is based on applying scientific and clinical expertise to decision-making, to ensure that the benefits to consumers
outweigh any risks associated with the use of medicines and medical devices.
 The TGA relies on the public, healthcare professionals and industry to report problems with medicines or medical devices. TGA
investigates reports received by it to determine any necessary regulatory action.
 To report a problem with a medicine or medical device, please see the information on the TGA website.
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3. Table of contents
Categories of applications
Processing times
Prescription Medicine Electronic Lodgement System
Certificate of Registration
Post Approval Changes – Variations
Fees - Standard prescription medicine
Requests with single fee
References
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4. Categories of applications
Therapeutic Goods Regulations 16A to 16G set out the conditions and statutory processing times relevant to each category
Category 1 applications
Category 1 applications are required for the following:
a new chemical/biological entity , a new generic medicine , new dosage forms , new strengths , extensions to indications , changes to the
product information , amendments to the Product Information (PI) , significant variations to an existing product.
Category 2 applications
Category 2 applications are required when the product to be registered is identical in all aspects to a product that has already been
registered in two acceptable countries i.e. Canada, Sweden, Netherlands, UK & USA.
Two independent evaluation reports need to be submitted with the application.
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6. Category 3 applications - Changes to the quality information requiring prior approval
Category 3 applications are required when there are changes to the quality data of a product that has already been entered into the ARTG,
and no clinical, non-clinical or bioequivalence data is required. A rationale is required to justify why clinical, nonclinical or bioequivalence
data is not required.
Categories of applications contd.
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7. Special cases of category 1 or 2 applications
1) Orphan drugs
An orphan drug is a medicine, vaccine or in vivo diagnostic agent, which is:
 intended to treat, prevent or diagnose a rare disease; or
 must not be commercially viable to supply to treat, prevent or diagnose another disease or condition.
2) Priority evaluations
Requests for priority evaluation should be discussed at a pre-submission meeting and will be considered in circumstances where:
 the active ingredient is a new chemical entity; and
 the medicine is indicated for the treatment or diagnosis of a serious, life-threatening or severely debilitating disease or condition; and
 there is clinical evidence that the medicine may provide an important therapeutic gain.
The allocation of priority evaluation status is not a guarantee that the total processing time of the application will be shortened, but the
evaluation process will be performed as rapidly as possible.
Categories of applications contd.
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8. Categories of applications contd.
3) Medicines for life-threatening conditions where no satisfactory alternative therapy exists
Where registration is being sought for a new medicine to treat a life-threatening illness or to treat a condition for which no satisfactory
alternative therapy exists, the TGA may accept the application in the US version rather than the usual EU version of the CTD format.
4) Literature based submissions
If the normal supporting data set is not available, the TGA will consider accepting literature based submissions for the purposes of updating
the PI documents of medicines with an extensive registration history, either in Australia or overseas. Under exceptional circumstances, a
literature based submission may be used for the registration of a new chemical entity in Australia where, although the product may not have
been in the ARTG, it has been approved in other countries for many years.
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9. Processing times
Category 1 and 2 applications
For Category 1 and 2 applications, the processing time comprises a period for acceptance of the application and a period for evaluation,
which begins on the day that the TGA notifies acceptance of the application.
Category 1 applications:
A decision to accept for evaluation or reject an application must be notified to the sponsor within 40 working days from receipt of the
application and the evaluation fee;
If accepted, the application must be evaluated in 255 working days from the date of acceptance.
Category 2 applications:
A decision to accept for evaluation or reject an application must be notified to the sponsor within 20 working days from receipt of the
application and the evaluation fee;
If accepted the application must be evaluated in 175 working days from the date of acceptance.
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10. Processing times contd.
Category 3 applications
For Category 3 applications, there is a single processing period , to be approved or rejected and the decision notified to the sponsor, or to
have an objection raised , within 45 working days of receipt of the application, or payment of the evaluation fee, whichever is the later day.
If, under the provisions of sub regulation 16F(3)(b), the Secretary raises an objection to the application, the applicant may respond and
provide further information or data.
A further 30 working days from receipt of this response is then allowed for consideration of the response before the application must be
approved or rejected.
If the Secretary has not notified the sponsor about the approval or rejection of a Category 3 application within:
45 working days of receipt of the application and fees, or
30 working days of receipt of the response to an objection , which indicates that the application is deemed to be approved.
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11. Prescription Medicine Electronic Lodgement System (PREMIER)
In order to register a prescription medicine, you need to create an e-business account for the Prescription Medicine Electronic Lodgement
System (PREMIER). When you have your username and password, you can enter the TGA online website and the PREMIER home page.
From here, you can create an application.
Your application should include the following:
client reference and details , indication of the submission type (category 1 or 2) , label name , proposed therapeutic indications , dosage
form , route of administration , container type and material . visual identification of dosage form , ATC code , Printed product material ,
Ingredient - including whether the ingredient is active, excipient, active homeopathic, or a proprietary ingredient , pack size , SUSDP
schedule that medicine falls under , Shelf life details , Manufacturer’s details including whether the manufacture is Australian or an
overseas manufacturer.
If an overseas manufacturer is selected then clearance ID or GMP reference number must be provided
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12. Certificate of Registration
Upon approval of a new register entry, the sponsor will be sent a Certificate of Registration with a unique AUST R number.
The annual registration charge is payable following registration. The sponsor should notify the TGA of the actual date of commencement of
marketing. The provisional ARTG record will have already been checked during the quality evaluation process and will become the ARTG
Record of Registration.
AUST R
15490
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13. Variations
Categories and timeframes
The TGA takes a risk-based approach to assessing variations to prescription medicines. This means that the higher the risk associated with the
variation, the greater the level of assessment required by the TGA for a decision to be made. There are three levels of assessment made by the
TGA for variations:
• Major variations, which require evaluation of a full dataset, or any combination of quality, nonclinical, clinical and bioequivalence data
(Category 1 and Category 2).
• Minor variations which do not have significant impact on quality , safety and efficacy further classified into following categories :
a)Changes that do not require prior approval
b)Corrections to an ARTG entry
c)Notifications
d)Minor Editorial Changes to product information (MEC)
e)Self-Assessable Requests (SARs)
f)Safety Related Requests (SRRs)
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14. Variations contd.
g)Category 3 requests - Changes requiring prior approval
Minor Variations
a)Changes that do not require prior approval
These are:
– changes that can be implemented without informing the TGA and
– changes that can be implemented before you inform the TGA of the change.
Examples:
1) Local handling agent of API and excipient, including material of biological origin(same site/method of manufacture, specifications
and, where applicable, biological source including geographical origin).
2) Change to Aust R number following an approved change requiring a new Aust R number, e.g. new formulation.
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15. Variations contd.
b) Corrections to an ARTG entry – a minor change to correct or complete information that was inadvertently recorded incorrectly or
omitted in the ARTG entry, including the product information (PI).
Example : Correct an ARTG entry - Manufacture
c) Notifications – very low risk variations with specific conditions. TGA approval for these variations is made automatically upon
lodgement and payment of the application fee. The applicant must provide legal assurances that all conditions are met and submit
supporting data using the approved electronic form.
Examples:
1) API container - changes to container/closure system of a non-sterile API
2) Drug product manufacture - changes to batch size for products that are not modified release dosage forms
3) Drug product specification - changes to identification tests for the active or excipient
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16. Variations contd.
d)Minor Editorial Changes to product information (MEC)
Example :
Any minor editorial changes to Labelling of Product Information.
e)Self-Assessable Requests (SARs) - lower risk variations for which the sponsor can provide an assessment of their own data for the TGA
to verify.
Examples :
1)Shelf life - Extension according to an approved stability-testing protocol
2)Formulation - addition or deletion of, or variation to, an inked imprint
3)Container/closure material - changes to material used for blister packs, strip packs and sachets of non-sterile dosage forms
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17. Variations contd.
f)Safety Related Requests (SRRs) - requests to either reduce the patient population that can receive the medicine or add a warning or
precaution.
Examples :
1)Product Information - Remove an indication with data
2)Product Information - Make safety related changes with data
g)Category 3 requests - Changes requiring prior approval - variations that require evaluation of quality-related data only.
Examples :
1) API manufacture - changes to the site(s) of manufacture
2)Drug product specifications - changes to specifications, including changes to test methods
3)Pack size - change to, or addition of, pack size
4)Shelf life - Changes to the shelf life or storage conditions of the drug product.
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18. Fees - Standard prescription medicine
Prescription medicine
application type
Application
fee Evaluation Fee
New chemical entity* $46,900 $188,200
Extension of indications* $28,000 $111,700
Major variations* $18,300 $72,800
Minor variation applications applied for under
section 23 of the Act (Change in formulation,
composition, design specifications, type of container
or change of trade name) $1,080 $4,280
Variations to an ARTG entry involving the
evaluation of clinical, pre-clinical or bioequivalence
data, applied for under 9D(3) of the Act. Includes
applications for
changes to Product Information involving the
evaluation of clinical, pre-clinical or bio-
equivalence data* $1,080 $4,280
Additional trade name $2,960 $11,900
New generic product* $18,100 $71,800
Extension of indications of a generic medicine to
maintain currency with indications already
registered to the corresponding innovator product
and where clinical and/or bioequivalence data
are not required $1,080 $4,270
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19. Requests with single fee
Prescription medicine request Fee Fee
Variations to an ARTG entry, applied for under section 9D(3) of the Act,
involving the evaluation of only chemistry, quality
control or manufacturing data. Includes applications for changes to Product
Information involving the evaluation of
only chemistry, quality control or manufacturing information $5,360
Minor editorial changes: variations to an ARTG entry (requiring changes to
Product Information) with no evaluation of data $1,650
Notification request $780
Correction to an ARTG entry $1,650
Self-assessable request with no
evaluation of data $1,650
Safety-related request with no evaluation of data $1,650
Safety-related request with evaluation of data $5,360
Request for advice in relation to a prescription medicine for
the purpose of listing the medicine as a pharmaceutical
benefit $2,170
Application for consent by the Secretary under sections 14
and 14A of the Act to the import, export or supply of
therapeutic goods that do not comply with an applicable
standard. $460
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20. References
1. https://www.tga.gov.au/
2. https://www.tga.gov.au/prescription-medicines-regulation-basics
3. https://www.tga.gov.au/standards-guidelines-prescription-medicines
4. https://www.tga.gov.au/forms-prescription-medicine-sponsors
5. https://www.tga.gov.au/book/export/html/757591
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