2.4 Fees for prescription medicine applications made under section 23 of the Act

Table 1 summarises the fee item numbers from Schedule 9 of the Regulations (covering both application fees and evaluation fees) payable by applicants for each of the application types lodged under s. 23.

Applicants should consult these item numbers in Schedule 9 of the Regulations when lodging an application, because the fees vary from year to year.

Each of these fee categories is discussed in further detail in subsequent sections.

Table 1: Fees at a glance - summary of s. 23 application types, timeframes and item numbers from Schedule 9 of the Regulations

Application typea	Application fee - item number	Evaluation fee - item number	Processed under prescription medicines registration process
New chemical entity	2(ba)	4(a)	Yes
Extension of indications	2(bd)	4(b)	Yes
New generic medicine	2(bg)	4(c)	Yes
Additional trade name	2(bh)	4(d)	No
Major variation	2(bi)	4(g)	Yes
Minor variation	2(bj)	4(h)	Yes (if clinical, nonclinical or bioequivalence data are required)
Minor variation (quality-related change)	2(bj)	4(h)	No (no clinical, nonclinical or bioequivalence data are required) Quality only data submitted
Minor variation (self-assessable request)	2(a)	Nil	No (if submitted as a self-assessable request)

^a Multiple applications are allowable as a 'submission' under Part 1 of Schedule 9.

Information about fee categories for prescription medicines used as an ancillary medical component of a device is available on the TGA website.

2.4.1 New chemical entity

This fee category relates to an application under s. 23 to enter a new chemical entity (fee items 2(ba) and 4(a)) in the ARTG. Part 1 of Schedule 9 to the Regulations defines a new chemical.

For the purpose of application fees, a similar biological medicine product (SBMP) is a new chemical entity as defined under Schedule 9 of the Regulations. These are biological substances that differ from the reference product because SBMPs:

• have a different molecular structure, or
• are derived from a source material of a different nature, or
• are derived from a different manufacturing process.

If the applicant can demonstrate that a new isomer, mixture of isomers, complex, derivative or salt of a registered drug substance does not change the pharmacokinetics, pharmacodynamics or toxicity of the moiety in a way that could change the safety and efficacy profile, the new medicine may be considered to be essentially similar to the registered drug substance, and the fee level would be for a generic product rather than a new chemical entity.

In these circumstances, it must also satisfy the other requirements for a new generic medicine.

2.4.2 Extension of indications for prescription medicines

Indications in relation to therapeutic goods are defined in s. 3(1) of the Act as the specific therapeutic uses of the goods. This fee category relates to an application under s. 23 to change the indications of an already registered medicine (fee items 2(bd) and 4(b)).

This fee category does not relate to applications for removal of indications made as 'safety-related' requests under ss. 9D(2) (see ss. 9D(2A), which has the effect of allowing this kind of application to be made under s. 9D, rather than s. 23, of the Act).

An application to extend the indications of a generic medicine to include a new indication is an extension of the indications, regardless of whether the reference product has that indication or not, and must be made under s. 23 of the Act. Alternatively, the applicant can apply for a new generic medicine with the new indications.

2.4.2.1 Generic medicine

This fee category relates to an application under s. 23 to register a generic medicine (fee items 2(bg) and 4(c)) for entry in the ARTG. Part 1 of Schedule 9 to the Regulations defines a generic medicine.

According to s. 25A of the Act, the Secretary cannot use 'protected information' relating to other medicines lodged by another sponsor to register a generic medicine. Protected information is information about an active ingredient included in a medicine that was first registered less than five years earlier, and is information about the active ingredient that is not in the public domain. A generic version of such a drug substance would require assessment as a new chemical entity.

2.4.3 Additional trade name

This fee category relates to applications under s. 23 to register an additional trade name as a separate entry in the ARTG based on an existing registration (fee items 2(bh) and 4(d)). A trade name is defined in r. 2 as the commercial name:

• given to goods of that kind by the manufacturer, and
• under which the goods are supplied.

The fee for an additional trade name only applies to applications in which an applicant has already registered a medicine under one trade name and is seeking to register the same medicine under another trade name. Applications involving a second applicant – that is, where the original applicant is seeking to register the medicine under another trade name on behalf of another applicant, or where a second applicant is seeking to register the medicine under another trade name – are applications for a new generic medicine.

2.4.4 Major variation

This fee category relates to applications under s. 23 to approve a major variation to an already registered medicine (fee items 2(bi) and 4(g)). The nature of the variation produces a separate and distinct good under s. 16 of the Act. Part 1 of Schedule 9 to the Regulations defines a major variation.

Strength is the quantitative composition in terms of drug substance. The strength represents the amount of drug substance in the pharmaceutical form, which can be defined per unit dose or as a concentration. The concentration can be stated per unit of mass (250 mg/g) or per unit of volume (2 mg/mL), or as a percentage (5 per cent).

For the purpose of this guidance, some examples are as follows:

• for single-dose preparations, the strength is defined as the amount of drug substance per unit dose
• for multidose preparations, the strength is defined as the concentration, expressed as the amount of drug substance per mL, per puff, per drop, per kg or per m², as appropriate
• for powder for reconstitution (powder for oral solution or suspension, powder for solution for injection, etc.)
  • single-dose preparations – the strength is defined as the quantity per container
  • multidose preparations – the strength is defined as the concentration after dissolution or suspension (reconstitution) to the volume and liquid recommended
• for concentrates for solutions (for injection or for infusion), single-dose preparations, the strength is defined as the quantity per container
• for transdermal patches, the strength is defined as the amount of active substance released from the patch in 24 hours.

Changes to the absolute amount of a drug substance may result in a new strength (as described above) and an application under s. 23 of the Act, or may be considered a variation under s. 9D of the Act. Examples of applications types that would result in a new strength or a variation are given in Annex 1.

A change in the intended patient group refers to any application that:

• alters the number of patients using a medicine; or
• modifies the category of patients using a medicine; but
• is not an extension of the indications or other major variation; and
• is not a safety-related notification; and
• is not an application for deletion of an indication.

Examples are an application to delete a contraindication or precaution, and some changes to the clinical trials section of the product information (PI).

2.4.5 Minor variation

This fee category relates to applications under s. 23 to approve a minor variation that results in a separate and distinct good under s. 16 of the Act (fee items 2(bj) and 4(h)). Part 1 of Schedule 9 to the Regulations defines a minor variation.

An application for a change in trade name can be considered a minor variation.

Minor variations can be lodged under the prescription medicines registration process (timeframe of 255 or 175 days, depending on the category of application) or outside the prescription medicines registration process (timeframe of 45 days), depending on the type of data required for the change. Under r. 16G, the following requirements apply to applications lodged outside the prescription medicines registration process:

• the applicant must hold a registration for the good containing the same active ingredient(s) in the same dosage form and strength
• the application must be of a kind that does not require the evaluation of clinical, nonclinical or bioequivalence data (e.g. applications for a replacement trade name).