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Mandatory requirements for an effective application

Applicable for applications lodged from 9 February 2018

21 February 2018

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Legislative requirements

Applications for new registrations

Applications for new registrations1 are made under Section 23 of the Therapeutic Goods Act 1989 (the Act). Section 23 requires that applications:

  • are made using a form approved by the Secretary (section 23(1) of the Act);
  • include information in a form approved by the Secretary (section 23(2)(b) of the Act); and
  • include such information as will allow the determination of the application (section 23(2)(b) of the Act).

The approved form is defined in a legislative instrument issued under section 23(1) of the Act. The requirement for the applicant to provide such information - in a form approved by the Secretary - to allow determination of the application is defined in a separate legislative instrument issued under section 23(2)(b) of the Act.

In summary, the Section 23 instruments specify that applications referred to in regulation 16C of the Regulations(that is, Category 1 and Comparable Overseas Regulator (COR) report-based applications for new registrations, other than applications for an additional trade name) must comply with the following regulatory documents:

In addition to the documents specified by the section 23 instruments, the TGA has produced the following other documents which assist applicants in the preparation of a PPF and an application dossier. These include:

Any departures from relevant requirements or guidelines must be explicitly justified in the application dossier. Some departures may require prior liaison with the TGA. See Justifications for further information.

In submitting a PPF, the applicant is indicating they understand and agree to comply with the General dossier requirements for a dossier to be considered effective and accepted for evaluation.

1A new registration is one that requires a new ARTG entry by reason of being separate and distinct goods under section 16 of the Therapeutic Goods Act 1989. This includes new chemical entities, new strengths, new dosage forms, different directions for use, formulation changes, changes in trade name, extension of indication etc. By the provisions in the Therapeutic Goods (Groups) Order 2001, not all new registrations will result in a new AUST R number being allocated if they are taken to be grouped.

Applications for variations

Applications requesting a variation to an existing registration are made under section 9D of the Act.

Legislative instruments issued under section 9D(6)(a) and section 9D(6)(b) describe the form and manner approved by the Secretary for applications made under section 9D(3), including the requirement to provide a dossier in CTD format.

For section 9D(3) applications to which regulation 16D of the Therapeutic Goods Regulations 1990 applies (i.e. Category 1 and COR report-based applications for variations), the legislative instruments set out a set of requirements similar to those for new registrations (above). The supporting documents listed above as applicable to new registration applications also apply to applications for variations.

Note

As with applications for new registrations:

  • Any departures from relevant requirements or guidelines must be explicitly justified in the application dossier. Some departures may require prior liaison with the TGA. See Justifications for further information.
  • In submitting a PPF, the applicant is indicating they understand and agree to comply with the TGA's requirements for a dossier to be considered effective and accepted for evaluation.

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