Legislative requirements

On this page: Applications for new registrations | Applications for variations

Applications for new registrations

Applications for new registrations¹ are made under Section 23 of the Therapeutic Goods Act 1989 (the Act). Section 23B(2) requires that applications:

• are made using a form approved by the Secretary;
• include information in a form approved by the Secretary; and
• include such information as will allow the determination (preliminary assessment)of the application.

Applications referred to in regulation 16C of the Regulations(including, 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:

• Pre-submission planning form (PPF)
• one of:
  • prescription medicines electronic lodgement facility (TGA Business Services), or
  • Application for the registration, or to vary the conditions of registration, of prescription medicines.
• Mandatory requirements for an effective application (this document)
• CTD Module 1: Administrative information and prescribing information for Australia
• Module 2: being overviews, written summaries and tabulated summaries of the data contained in the Modules 3, 4 and 5 as described below
• Module 3: ICH M4Q Common technical document for the registration of pharmaceuticals for human use - Quality (CPMP/ICH/2887/99 Rev 1 Quality)
• Module 4: ICH M4S Common technical document for the registration of pharmaceuticals for human use - Safety (CPMP/ICH/2997/99 Rev 1 Safety)
• Module 5: ICH M4E Common technical document for the registration of pharmaceuticals for human use - Efficacy (CPMP/ICH/2887/99 Rev 1 Efficacy)

The following guidance will assist applicants in the preparation of a PPF and an application dossier:

• Prescription medicine registration process
• COR report-based process guidance
• Priority review registration process
• Information for applicants completing a pre-submission planning form
• Electronic submissions
• General dossier requirements

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.