1.5 Specific requirements for different types of applications

On this page: Overview | Summary of requirements | Module 1.5.1 Literature-based submission documents | Module 1.5.2 Orphan drug designation | Module 1.5.3 Genetically modified organisms consents | Module 1.5.5 Co-marketed medicines declarations | Module 1.5.6 Combination medicines consent | Module 1.5.7 OTC New product assurances | Module 1.5.8 Analytical validation summary

Overview

This section of Module 1 holds multiple documents required for specific types of regulatory activities.

Summary of requirements

Documentation

Section	Description	Category 1/COR report-based		Variations to quality only (e.g. Category 3)
		New registration	Variation	New registration	Variation
1.5.1	Literature-based submission documents (if literature-based submission)	mandatory	mandatory	not required	not required
1.5.2	Designation applications - supporting documents	mandatory	not required	mandatory	not required
1.5.3	Genetically modified organisms consents	requirement defined by the regulatory activity	requirement defined by the regulatory activity	not required	not required
1.5.4	not required
1.5.5	Co-marketed medicines declarations (if applicable)	mandatory	requirement defined by the regulatory activity	mandatory	requirement defined by the regulatory activity
1.5.6	Combination medicine consent (if submission for a new combination)	mandatory	not required	not required	not required
1.5.7	OTC product assurances	Refer to OTC Guidance document. Not required for prescription medicine applications.
1.5.8	Umbrella brand assessment	Refer to OTC Guidance document. Not required for prescription medicine applications.

Module 1.5.1 Literature-based submission documents

When to include information about literature based submissions

Include where the application partially or completely relies on a literature-based data set to support the application.

How to prepare information about literature based submissions

For literature based submissions involving a systematic literature search, three items need to be prepared:

• Module 1.5.1.1 - methodology of literature search, including complete details of database search strategies
• Module 1.5.1.2 - a copy of the letter from the TGA in which approval for the search strategy is given
• Module 1.5.1.3 - complete search output.

For literature based submissions NOT involving a systematic literature search, Module 1.5.1.1 and Module 1.5.1.3 only need to be prepared.

Note:

A literature-based submission uses literature references, rather than studies, for part or all of the supporting data required in the dossier to establish quality, safety, and efficacy.

Generally, the TGA will only accept literature-based submissions for medicines with an extensive registration history either in Australia or overseas.

A submission comprising a mix of conventional and literature-based data is treated in the same manner as a pure literature-based submission.

When completing the application form:

• confirm the search strategy used to generate the search output for the application is in full accordance with the search strategy approved by the TGA
• or
• document and include the reasons for all changes if not in full accordance with the search strategy approved by the TGA.

Module 1.5.2 Designation applications - supporting documents

When to include information about Priority review determination and/or Orphan drug designation

Applicants must include a valid Priority review determination letter from the TGA when making an application under section 23 of the Act for the Priority review registration pathway.

Applicants must include an Orphan drug designation decision letter from the TGA when requesting that fees be waived for an application under section 23 of the Act.

How to prepare information about a Priority review determination or Orphan drug designation

Locate the TGA letter granting the Priority review determination or Orphan drug designation and check the letter and the application to ensure:

• the applicant identified on the letter is identical to the applicant for the submission
• the active ingredient(s) specified on the letter is/are identical to those in the application
• the indication(s) proposed in the application are identical to, or narrower than, those stated on the determination and/or designation letter
• for Orphan drug designated medicines, the dose form stated on the designation letter is identical to the dose form in the application.

Include a copy of the TGA letter granting Priority review determination and or Orphan drug designation in Module 1.5.2.

Applications that do not have a designation or determination in force will not be eligible for the Priority review pathway or the Orphan drug fee waiver.

Guidance on how to apply for Priority review determination or Orphan drug designation is published on the TGA website.

Module 1.5.3 Genetically modified organisms consents

When to include information about genetically modified organisms

Include where the application seeks the registration of:

• a medicine that contains or consists of genetically modified organisms (GMOs)
• a medicine that is derived from a GMO manufactured in Australia and is subject to regulation by the Office of the Gene Technology Regulator (OGTR).

How to prepare information about genetically modified organisms

• Consult the OGTR to determine requirements under the Gene Technology Act 2000 before lodging the Pre-submission planning form.
• A licence or another form of consent may be required from the OGTR. Refer to Module 1.5.3 of Information for applicants completing a pre-submission planning form for more information.
• Include in Module 1.5.3 copies of any
  • licence
  • acknowledgement of receipt of application for a licence
  • other written consent from OGTR
  • declaration regarding an exemption for the medicine under part 1 of schedule 2 of the Gene Technology Regulations 2001.

Related information and guidance

TGA Guidance 21: Medicines produced by genetic manipulation.

Module 1.5.5 Co-marketed medicines declarations

When to include a co-marketed medicine declaration

Include this document in Module 1.5.5 when:

• a cross-licensing agreement exists between the applicant of the current submission and a third-party sponsor
• the third party sponsor authorises the TGA to use information on its product (that is either on the ARTG or under evaluation) for the benefit of the first party's application
• the applicant's product will be identical or very similar to the third-party's product.

How to prepare a co-marketing medicine declaration

Third party sponsor

The third party sponsor must provide the applicant lodging the submission with a letter that:

• Authorises the TGA to use information in their registration file on behalf of the applicant of the new application.
• Identifies the eSubmission Identifier, submission ID and file numbers relating to their data/information.
• Identifies the following aspects of their medicine that are the subject of their data/information:
  • trade name(s)
  • active ingredient name(s)
  • dosage forms
  • strengths.
• States whether the applicant of the new application may view the information on file.
• Advises of the extent of the authorisation encompassing:
  • the reason for the application (for example, permission to access data for the change in formulation)
  • any restrictions (for example, applies to tablets only, not capsules).
• Identifies which party is responsible for answering queries relating to the third party data/information.
• Contains:
  • full name of the authorised officer
  • phone number
  • facsimile number
  • email address
  • signature of the authorised officer.
• Where the application concerns a copy of a medicine registered on the ARTG to a third party sponsor, the following must be provided:
  • a declaration confirming the completeness and accuracy of the ARTG record of the third party product for all data fields
  • or
  • evidence the TGA has been requested to correct the record (including the submission ID or eSubmission identifier and sequence for the correction), together with an assurance that all other aspects of the ARTG record are identical.

Applicant

Where the application concerns a copy of medicine registered on the ARTG to a third party sponsor, the applicant of the submission must provide:

• A declaration that all quality (Module 3) aspects of the new product are identical to the third party product except for labelling; or
• information on any differences together with a declaration that all other quality (Module 3) aspects are identical.
• A declaration that the PI and CMI of the new product(s) are identical to those of the parent product(s)(except for the trade name and applicant's name and address); or
• a complete list of the differences.

Note:

Ensure the third party has lodged their data before lodging the application. Failure to provide a third party's data may result in an application being considered not effective.

To avoid delays in evaluating the application, requests to make corrections or variations to the ARTG entry for the third party's already registered product must be submitted to the TGA well in advance of lodging a submission for the co-marketed medicine.

odule 1.5.6 Combination medicines consent

When to include information about combination medicines consent

If the proposed product(s) is a new fixed combination, attach a copy of the TGA's letter advising that the justification for fixed combination is acceptable.

Fixed combination products may be presented as composite packs (i.e. with multiple dosage forms), multiple ingredients within a single dosage form, or a combination of both.

Module 1.5.6 does not apply to fixed combination regulatory activities for new generic medicines.

How to prepare information about combination medicines consent

For a new fixed combination product the applicant must justify, prior to lodging a PPF, the particular combination and the type and extent of data to be provided in the dossier. This is done by preparing and lodging with the TGA a 'justification for fixed combination' as described in the TGA guidance on Fixed combination prescription medicines. If your justification is accepted, attach a copy of the letter advising this in Module 1.5.6.

Module 1.5.7 OTC New product assurances

Refer to OTC Guidance document. Not required for prescription medicine regulatory activities.

Module 1.5.8 Umbrella brand assessment

Refer to OTC Guidance document. Not required for prescription medicine regulatory activities.