2.5 Fees for requests to vary an ARTG entry for prescription medicines under section 9D of the Act

Table 2 summarises the fee item numbers from Schedule 9 of the Regulations payable by applicants for each of the request types lodged under s. 9D. Applicants should consult these item numbers in Schedule 9 of the Regulations when lodging a request, as these fees vary from year to year.

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

2.5.1 Requests for variations without data (item 2A(a) of Schedule 9 of the Regulations)

The application and evaluation fees that apply to this category of requests to vary information in the ARTG under s. 9D of the Act cover simultaneous requests for variations of a minor nature:

• with the same drug substance,
• that are submitted by the same applicant, and
• do not require evaluation of data.

The submission involves a minor variation or variations under one or more of ss. 9D(1), 9D(2) or 9D(3) of the Act. Requests of this type only attract one payment, provided that the variations contain the same drug substance and are appropriately identified for simultaneous lodgement by the applicant.

2.5.1.1 Variation request under subsection 9D(1) of the Act

This fee category (fee item 2A(a)) covers variations to correct or complete information that was inadvertently recorded incorrectly or omitted in the ARTG entry, including the PI.

In some cases, errors in quality-related specifications may need to be corrected. For example;

• correcting typographical errors in quantities of excipients,
• correcting grammatical errors in the records held about a product, or
• adding a manufacturing step for a licensed manufacturer that was inadvertently omitted.

2.5.1.2 Variation request under subsection 9D(2) of the Act

This fee category (fee item 2A(a)) covers safety-related requests to vary an entry in the ARTG. A safety-related request is one where the variation has one of two possible outcomes:

• to reduce the class of persons for whom the goods are suitable; or
• to have the effect of adding a warning or precaution.

2.5.1.3 Variation request under subsection 9D(3) of the Act

This fee category (fee item 2A(a)) covers variations that are not safety related (i.e. do not meet the criteria for a safety-related request under subs. 9D(2)), provided that the variation:

• does not reduce the quality, safety or efficacy of the product, and
• does not create a separate and distinct good.

Variations made under ss. 9D(3) often relate to the quality of registered prescription medicines. Minor editorial changes to the PI are also included in this fee category.

Subsection 9D(3) applications submitted under this fee category will be accepted in accordance with the TGA guidance Minor variations to registered prescription medicines: chemical entities and Minor variations to registered prescription medicines: biological medicines.

Where an application under ss. 9D(3) requires evaluation of quality data only, item 2B applies (see 'Quality-related variations (chemistry, quality control and manufacturing information)').

Where an application under s. 9D(3) requires evaluation of nonclinical, clinical or bioequivalence data, items 2AC and 2C apply (see 'Requests to change the PI that requires evaluation').

2.5.2 Quality-related variations (chemistry, quality control and manufacturing information)

This fee category (fee item 2B) relates to a request under s. 9D(3) covered by any of the changes described in r. 16F(1) of the Regulations. The kinds of changes covered by this fee category are variations to:

• the specifications for the drug substance, medicine or excipients; or
• the method of manufacture of the drug substance; or
• the manufacturing procedure for the medicine; or
• the site of manufacture of the drug substance or the medicine; or
• the shelf life; or
• the storage conditions; or
• the product label; or
• any other particular that is not mentioned in subs. 16(1) of the Act.

Consistent with r. 16F(2)(b), applicants can only submit this type of request if it does not require the evaluation of clinical, nonclinical or bioequivalence data.

2.5.3 Safety-related request to change product information requiring evaluation of clinical data

This fee category (fee item 2CA) relates to variations under ss. 9D(2) of the Act.

These are applications that require evaluation of data to make safety-related changes to the PI. That is, the variations reduce the class of persons for whom the goods are suitable, or have the effect of adding a warning or precaution.

2.5.3.1 Requests to change the PI that requires evaluation

This fee category (fee items 2AC and 2C) relates to requests to change the PI that require evaluation of clinical, nonclinical and/or bioequivalence data, where r. 16D applies (i.e. evaluation completed within either 255 or 175 days).

Applications under this fee category must be submitted via the prescription medicines registration process.