Phase 2: Submission

Last updated

12 August 2021

5.2.1 Objective

a diagram showing the steps of the submision phase

The submission phase involves processing activities in preparation for application evaluation. For the TGA, processing activities include:

confirmation of dossier delivery by the expected lodgement date
verification that any application fee has been paid
workflow planning and IT administration
consideration of the application against the TGA regulatory requirements
issuing of a Notification letter, including notice of evaluation fee payable, if applicable.

5.2.2 Milestone 2

The TGA sends a letter to the applicant identifying whether the application has been considered effective and accepted for evaluation, or considered 'not effective'.

5.2.3 Key dates

The submission phase commences with receipt of the dossier. The dossier is expected to contain all the information required by the TGA to evaluate the application(s).

For applications to register:

a new chemical entity
a new biological entity
a new fixed combination
a similar biological medicinal product
an extension of indications

the dossier must be received by TGA before close of business (5.00 pm) on the seventh of the month following receipt of the Planning letter (or the following working day where the seventh falls on a weekend or public holiday in the Australian Capital Territory), unless another date is specified in the Planning letter.

For applications to:

register a major variation
register a minor variation
register a new generic medicine
vary the PI

the dossier must be received by TGA before close of business (5.00 pm) on the 14th of the month following receipt of the Planning letter (or the following working day where the fourteenth falls on a weekend or public holiday in the Australian Capital Territory).

The submission phase concludes when TGA sends the applicant a Notification letter. This letter is sent to applicants before the end of the month in which the dossier was lodged (or the following working day where the last day of the month falls on a weekend or public holiday in the Australian Capital Territory).

The Notification letter will advise the applicant whether the application is effective or not (Section 9D(7) and Section 23of the Act). If an application is considered not effective the Notification letter will explain why it was considered not effective.

5.2.4 Lodgement of application

Applicants of all new chemical entity, new fixed combination, and new generic medicine applications must electronically lodge their application through eBS prior to sending the hard and electronic copies of the dossier to the TGA. In this context, 'electronic lodgement' means the applicant has created an application in eBS and subsequently printed out an application form and an electronic lodgement cover sheet for inclusion in Module 1 of the dossier. Electronic lodgement, in this context, does not mean the dossier has been lodged electronically.

5.2.5 Processing the application

5.2.5.1 Effective applications

An application will be considered effective and accepted for evaluation if:

the dossier arrives by the expected date (as identified in the Planning letter) following the lodgement of a complete PPF, and is consistent with the information in that form
it includes the completed form: Application for the registration, or to vary the conditions of registration, of prescription medicines, or the eBS electronic equivalent (both of which include applicant declarations that all data for evaluation by the TGA has been presented at the time of dossier lodgement)
it satisfies and is in accordance with relevant TGA regulatory requirements (see below).

5.2.5.2 TGA regulatory requirements

Applicants must abide by all applicable requirements. These requirements include, but are not limited to, those set out in:

Therapeutic Goods Act 1989
Therapeutic Goods Regulations 1990
all relevant:
- Therapeutic Goods Orders
- ICH and CHMP guidelines that have been adopted by the TGA, and other Australia-specific guidelines
legislative instruments made under section 9D and section 23 of the Act, which encompass:

5.2.5.3 Evaluation fee

The full evaluation fee is due and payable when the applicant is notified that the application is accepted for evaluation. The Notification letter will specify the evaluation fee amount payable. If the evaluation fee for an application for the registration of a prescription medicine is not paid within two months from the date of the Notification letter, the application will lapse (see section 24(2) of the Act ).

The evaluation fee amounts are available at the fees and payments section of the TGA website.

5.2.5.4 Applications not accepted

Applications that do not meet the TGA's regulatory requirements will be considered 'not effective'. Applicants of applications considered 'not effective' will be notified in writing of the reasons the application was not accepted for evaluation. If the applicant wishes to proceed with the application they must lodge a new PPF and potentially a new dossier (see section 4.2 - Availability of dossier).

The dossier becomes a Commonwealth record once processing commences and cannot be returned to the applicant.

5.2.6 What happens if an applicant misses a key date?

Applicants are encouraged to contact the TGA as soon as possible if they believe that they will be unable to lodge the dossier by the expected date to allow the TGA to reallocate resources that have been assigned to the application. A revised evaluation plan will be negotiated through the relevant Case Manager.

If an application does not arrive by the expected date, the TGA will reallocate the evaluation resources assigned to that application. In such cases, the applicant will forfeit any application fee and must begin the application process with lodgement of a new PPF. If processing of the application did not commence, an applicant will be able to make arrangements to retrieve the dossier.

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