1.2 Administrative information

On this page: Overview | Summary of requirements | Module 1.2.1 Application form | Module 1.2.2 Pre-submission details | Module 1.2.3 Patent certification | Module 1.2.4 Change in sponsor

Overview

This section of Module 1 contains the application forms, pre-submission details, patent certification documents and change in sponsor information for prescription medicine applications.

Summary of requirements

Module 1.2.1 Application form

How to prepare the application form

Download and complete the appropriate application form from the TGA website or complete an application using the appropriate e-form:

• Application form to register or vary the registration of prescription medicines

  Use this form for the following Category 1 and COR report-based prescription medicines applications or variations where the dossier includes nonclinical, clinical or bioequivalence data:

  • extension of indications [C]
  • major variation (new dosage form, change/increase in patient group, change in dosage, new strength, new route of administration) [F]
  • change in formulation [G]
  • change in container type (disregarding container size) [G]
  • other variation (requiring evaluation of clinical, nonclinical, or bioequivalence data) [H]
  • variation to Register entry resulting in a change of product information requiring evaluation of clinical, nonclinical, or bioequivalence data [J]

  If you are making a COR report-based application, attach the Checklist for the COR report-based process (COR-A and COR-B). This checklist is mandatory for all COR report-based applications and helps the applicant identify whether their application meets requirements for a COR-A or COR-B approach.

• Use TGA Business Services (TBS) e-form for other Category 1 applications (type A, B and D)
  • If you are making a COR report-based application, attach the Checklist for the COR report-based process (COR-A and COR-B). This checklist is mandatory for all COR report-based applications and helps the applicant identify whether their application meets requirements for a COR-A or COR-B approach.
• Use the Additional trade names application form when applying for an additional trade name for a registered prescription medicine.
• For variations to prescription medicines:
  • Use TGA Business Services (TBS) e-form. The application form is then replaced with the print preview which can be obtained after successfully validating an application.

General application form information

ARTG information and provisional ARTG record

The information entered in the application form is the basis of the new/revised ARTG entry. It is critical that this information is entered accurately and is an accurate reflection of the information provided in the dossier.

Before the application is approved, the information that forms the basis of the new/revised ARTG entry is called the Provisional ARTG Record (PAR). The information included on the PAR is updated as required during evaluation of the application.

Once the PAR is written to the ARTG, the final information becomes the ARTG entry for the product.

Proposed indications

The indications recorded on the application form for the registration of a new chemical entity, new biological entity or an extension of indications must be identical across:

• the application form
• cover letter (if included in letter)
• the product information document (apart from the use of a trademark and copyright symbols).

Manufacturing steps

The sponsor should ensure that their manufacturing licence or GMP Clearance should cover the manufacturing steps of the dosage forms that are to be performed by each of the manufacturing sites.

In some instances, the manufacturing steps shown on a manufacturing licence or GMP clearance issued by the TGA may not be identical to the individual manufacturing steps that need to be entered on the prescription medicine application form. This may be because the manufacturing licence or GMP clearance is using 'group terms'. Refer to the Code Tables in TGA Business Services if it is unclear what is included within a manufacturing step or dosage form group term on a manufacturing licence or GMP Clearance.

Ingredient names

The non-proprietary ingredients in the formulation must be specified using either:

• Australian approved names (AANs) or the proposed AANs
• Australian approved biological names (ABNs) or the proposed ABNs

A list of AANs and ABNs is available in the Ingredients Repository within TGA Business Services and further information on Ingredient naming requirements and categorisation is available on our website or via email to tganames@tga.gov.au.

For new ingredients and new proprietary ingredients, the completed Application form for proposing a chemical (AAN)/biological (ABN) name or Notification of a New Proprietary Ingredient form (respectively) must be lodged with the TGA before the Pre-submission planning form is lodged.

New medicines cannot be registered until all ingredients have either an AAN or ABN, or have been included as a proprietary ingredient in the ARTG.

Module 1.2.2 Pre-submission details

When to include the pre-submission details

When a Pre-submission planning form (PPF) has been lodged for a category 1 or a COR report-based application, a copy of the PPF must be included at Module 1.2.2.

A PPF is not required for variations submitted through the variations e-form.

How to prepare information about the pre-submission details

After lodging a PPF via TBS:

• go to the 'lodged submissions' view in TBS and locate the PPF
• include the document at Module 1.2.2.

It is not necessary to include the attachments to the PPF as these will be held by the TGA.

Module 1.2.3 Patent certification

When to include the patent certification

Before a newly approved registration can be included in the ARTG, one of the following forms is required to satisfy legislative requirements under section 26B of the Act:

• Certification in relation to patents required in relation to registration or listing under Sections 25, 26 and 26A of the Therapeutic Goods Act 1989
• Notification to the Secretary that a Certification under section 26B(1) of the Therapeutic Goods Act 1989 is not required.

All regulatory activities for new registrations, including formulation changes including those that retain the same AUST R number, changes in trade name, and extensions of indication, require the applicant to provide one of the above forms before the registration process can be finalised.

Applications for a similar biological medicinal product or a generic medicine which result in a new registration must complete the Certification in relation to patents required in relation to registration or listing under Sections 25, 26 and 26A of the Therapeutic Goods Act 1989.

How to prepare the patent certification

• Locate and open the appropriate form
• complete and sign the form in accordance with the instructions provided on the form
• include the document at Module 1.2.3.

Module 1.2.4 Change in sponsor

When to include change in sponsor details

For Category 1 and COR report-based applications, the sponsorship of an application can be changed prior to the milestone 5 date indicated in the evaluation plan, regardless of whether or not evaluation reports have been received by the applicant.

For other regulatory activities or after milestone 5 of a category 1 or COR report-based application, the sponsor's name should only be changed after the regulatory activity has concluded with writing of the record to the ARTG.

How to provide the change in sponsor details

For a transfer of sponsorship follow the guidance on the TGA website.

If your submission is currently under evaluation include:

• a copy of the notification of a change in sponsorship
• a letter from the original sponsor confirming that the new sponsor has access to all previously submitted data. If this is not the case, the original sponsor and the new sponsor must complete the Co-marketed medicines declarations (Module 1.5.5).

Note:

Also include the following documents:

• Letters of access for DMF, PMF and CEP holders regarding access to confidential parts of these documents (Module 1.6.3)
• Revised medicine information and labelling where changes have been made:
  • Revised Module 1.3.1.1 and Module 1.3.1.2: Australian product information (clean and annotated copies)
  • Revised Module 1.3.1.4: (package insert)
  • Revised Module 1.3.2.1 and Module 1.3.2.2: Australian consumer medicines information (clean and annotated copies)
  • Revised Module 1.3.3: Label mock-ups and specimens.

For a change in sponsor name (same legal entity but change of name) include:

• a declaration in the Cover letter that, with the exception of a change to the sponsor name, the sponsor (company) has made no other changes that may reasonably be expected to impact on or affect the submission under evaluation.
• Revised medicine information and labelling where changes have been made:
• Revised Module 1.3.1.1 and Module 1.3.1.2: Australian product information (clean and annotated copies)
• Revised Module 1.3.1.4: (package insert)
• Revised Module 1.3.2.1 and Module 1.3.2.2: Australian consumer medicines information (clean and annotated copies)
• Revised Module 1.3.3: Label mock-ups and specimens.