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Information for applicants completing a pre-submission planning form

Applicable to pre-submission planning forms lodged under the prescription medicines registration process from 1 May 2014

1 May 2014

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Part 1: Applicant and product details

1.1 Applicant details

How to complete this information

Record the information requested in the spaces provided.

Ensure that where the postal address differs from the street address you have provided the postal address.

What else do I need to do?

Applicants who do not have an eBS client ID will need to apply for an eBS client ID before lodging a PPF. This can be done through the eBS website.

Ensure that at least one of the nominated contact persons are available throughout the evaluation process, particularly in the 12 weeks following PPF lodgement, to respond to any questions the TGA may have about the PPF and dossier. If the contact persons or the contact information changes during the pre-submission/evaluation processes, the TGA case managers should be informed immediately.

Case managers should be conducted through the prescription medicines registration process mailbox and the subject line should include the following: PM-XXXX-XXXXX-X-X Applicant name active ingredient.

1.2 Product details

Medicinal product details

How to complete this information

Indicate whether the proposed products contain a single active ingredient, multiple active ingredients, and whether or not they are multi-component. A product can be both single or multiple active ingredients, and a multi-component product.

Indicate whether the product is: a biological substance, sterile, a product of a fermentation process, composed of a sterile active ingredient that is not subjected to further sterilisation during drug product manufacture, multi-dose, or supplied with a device. Where the product is supplied with a device, record the details in the space provided.

There are multiple sections of legislation regulating biologicals (i.e. products containing one or more active ingredients that are biological substances). You will need to confirm that you lodging your application under the appropriate legislation (see below). You should only lodge a PPF if lodging an application under section 23 or section 9D(3) of the Act for a prescription medicine. You should not lodge a PPF if lodging an application under section 32A of the Act.

Regulation of biological products - prescription medicines and the biological framework

A product containing a biological substance will be regulated under the Biologicals Regulatory Framework if it meets the definition of a biological under section 32A of the Act.

Goods declared to not be a biological are not included in the Biologicals Regulatory Framework but are regulated as either a medicine or a medical device. These products are included in the Therapeutic Goods (Things that are not Biologicals) Determination No.1 of 2011.

The following products are currently declared to not be biological and are regulated as prescription medicines:

  • biological medicines including:
    • vaccines (that do not contain viable human cells)
    • recombinant products
    • plasma-derived products (or that contain plasma-derived products).

Product table

How to complete this information

Complete the information in the table for every product that will be affected by the application. Appendix A contains examples of how to complete this table for different product types.

Note:

  • for existing products, the Aust R number must be included
  • for new registrations, all trade names must be recorded in the table[1]
    • if the trade name is undecided at the time of PPF lodgement, record '[trade name]' in the trade name field.
    • if multiple unknown trade names are to be sought, record the total number of unknown trade names proposed in the trade name field
  • record the active ingredients in full, including the salt or ester
  • the Australian approved name (AAN), approved biological name (ABN) or approved herbal name (AHN) must be used when recording the active ingredients. Where an AAN/ABN/AHN has not yet been allocated, record that an application has been made for the name (see Part 2, Section 2.1, Ingredients/proprietary ingredients for more information) and ensure that the proposed AAN/ABN/AHN is used in the PPF.
  • for multiple ingredient products and multi-component packs, see Appendix A for examples.

If there is insufficient space in the table for all the proposed products, insert the comment 'see attached document' in the first row. Create a separate document with a table in the same format and record all products. Upload the document as an attachment when lodging the PPF in eBS.

Important note

To ensure accuracy and consistency of the information recorded on the Australian Register of Therapeutic Goods (ARTG), the TGA maintains lists of Australian approved terminology. For medicines, the lists cover substances (active ingredients and excipients), containers, dosage forms, routes of administration, and units of expression and proportion. It is essential that when completing the product table, applicants use Australian approved terminology where relevant.

If the product comprises a novel dosage form, uses a novel container type or novel ingredients, applicants must apply to the TGA for approval before lodging the PPF. Procedures for applying for new ingredient names are covered under Part 2, Section 2.1, Ingredients/proprietary ingredients. For novel container types and dosage forms, contact the TGA for advice.

What else do I need to do?

Whilst a PPF can be lodged before the trade name is decided, the trade name must be decided prior to application lodgement as label mock-ups, product information, and various other documentation provided in the dossier must show the proposed trade name.

Refer to the TGA's Questions and Answers page for more information about checking proposed trade names before lodging a PPF.

Nature of proposed application(s) - New registrations

How to complete this information

Select one or more of the check boxes to indicate the application type(s) in the submission.

Where applicants wish to register a similar biological medicinal product:

  • provide the details of the reference active ingredient and reference trade product (proprietary name)
  • select the appropriate check boxes to indicate if the reference product is registered in Australia and has the same form/strength/route of administration
  • select the appropriate check boxes to indicate if additional comparability studies have been conducted and whether the same INN/ABN as the reference product is being requested
  • where the protected information period has not yet expired, indicate whether it will expire before application lodgement

Note: Where the protected information period does not expire before the application lodgement date, the TGA will be unable to evaluate the application. Applicants seeking the registration of a new similar biological medicine where the protected information period has not yet expired may choose to prepare and lodge a dossier consistent with the technical requirements of a new chemical entity application instead.

Note: Applications for the registration of similar biological medicinal products are treated as new chemical entity applications for the determination of fee category determination. For further information, see CTD Module 1, and the similar biological medicinal product guidelines adopted in Australia.

Where applicants wish to register a new generic medicine:

  • provide the details of the reference product and record whether the protected information period has expired
  • where the protected information period has not yet expired, indicate whether it will expire before application lodgement

    Where the protected information period does not expire before the application lodgement date, the TGA will be unable to evaluate the application. Applicants seeking the registration of a new generic medicine where the protected information period has not yet expired may choose to prepare and lodge a new chemical entity application instead.

  • indicate if an overseas reference product was used for the bioequivalence studies

    Where an overseas reference product was used, a justification for doing so must be recorded in Part 2, Section 2.3 - Justifications and further information. The justification must address all the criteria in the TGA guideline on Biopharmaceutical studies.

Additional trade name applications on their own do not require the completion of a PPF. Where an additional trade name application is being lodged concurrently with an application for a new registration (for example, a new strength):

  • tick the box corresponding to the nature of the new registration
  • ensure all trade names are recorded in the product details table. If the trade name is undecided at the time of PPF lodgement, record [trade name] in the trade name field.

Nature of proposed application(s) - Variation to Register entry

How to complete this information

Where 'other variation' is selected, the details must be recorded in the 'further detail' field provided.

What else do I need to do?

Applicants must ensure that the application lodged reflects the application type identified in the PPF, unless advised otherwise by the TGA in the Planning letter.

For new generic medicines, applicants must ensure the protected information period for the reference product expires before the application lodgement date. The TGA cannot evaluate new generic medicine applications where the protected information period has not expired and will consider such applications to be not effective.

Proposed schedule

How to complete this information

Where a new substance is proposed, select from the drop-down list the proposed schedule for the substance in the Poisons Standard (SUSMP).

What else do I need to do?

Applicants of new substances should review the National Coordinating Committee on Therapeutic Goods scheduling policy framework. This document explains the processes for scheduling new substances and provides an overview of the types of evidence required to support an application for a particular schedule.

The Secretary or her delegate is responsible for scheduling decisions. A decision on the appropriate schedule for a new substance is made during the decision phase of the evaluation process.

Where an applicant wishes to apply for the rescheduling of a substance already included on the SUSMP, this must be completed prior to application lodgement.

1.3 Indication(s)

How to complete this information

Proposed indications

For a new chemical/biological entity, new combination, similar biological medicinal product or new generic medicine, record the proposed indications, in full, in the first box provided.

For applications involving a change to the currently approved indications record the proposed indications in the second box provided.

For applications where no change is proposed to the indications, tick the no box immediately above the second box and enter 'as currently registered' in the second box.

Currently approved indications

For applications other than a new chemical/biological entity or a new combination, record the currently approved indications. For a new combination, record the currently approved indications for the individual components of the new product. For new generic medicines or similar biological medicinal products, record the approved indications of the reference product in Australia.

Indicate clearly where different indications are proposed for different products in the proposed application. For example:

  • 1.5mg tablet
    For the treatment of post-operative nausea
  • 10mg injection
    For the treatment of post-operative nausea and vomiting

If there is insufficient space to record the full indications, insert into the field the comment 'see attached document'. Create a separate document with the title '1.4 - Indications' that shows the indications in full. Upload the document as an attachment when lodging the PPF in eBS.

Further information

When applying for a new generic medicine or a major variation, the proposed indications must be the same as, or narrower than, those registered for the reference product(s). If this is not the case, an extension of indication application type, additional data requirements and a higher evaluation fee may apply.

The indications recorded in this field must be essentially the same as those applied for in the dossier. If the indications proposed in the dossier are broader than those specified in the PPF, this may be grounds for the TGA to consider the application not effective and not accepted for evaluation. Any difference between the PPF and the dossier must be described and justified in Module 1.8.3 of the dossier. See CTD Module 1 for further information.

1.4 Submission planning

Overview of application

How to complete this information

Applicants must provide a brief summary of the application, including an overview of the product to be registered and/or proposed variation(s).

If the PPF relates to a previous ineffective PPF or application, applicants must include in the 'Overview of application ' section details on how they have addressed deficiencies identified in the previous PPF or application.

The field will expand to accommodate the overview of the application, however, if there is insufficient space, insert the comment 'see attached document ' in the field. The applicant should then create a separate document containing the required information and upload the document as an attachment when lodging the PPF in eBS.

Dossier lodgement date - How to complete this information

Record the date on which the dossier will arrive at the TGA.

TGA will require dossiers for new chemical/biological entities, similar biological medicinal products, new fixed combinations and extensions of indications to be received the working day prior to the 8th of the month in which they will be processed. Unless otherwise advised, all other dossiers must be lodged, at the latest, the working day prior to the 15th day of the month in which they will be processed.

Further information

If the date proposed by the applicant is acceptable to the TGA, it will be confirmed in the Planning letter provided by the TGA to the applicant in response to the PPF. If the date proposed by the applicant needs to be amended, the TGA will state the reasons for the amendment in the Planning letter.

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 PPF is lodged 2¼ months prior to the expected lodgement date of the dossier. For other applications the PPF is lodged 2½ months prior to the expected lodgement date of the dossier.

Applicants commit in the PPF to lodging the dossier (including the completion of relevant lodgement activities in eBS, where appropriate) by the nominated application lodgement date. Applications not received by the lodgement date will be considered to have lapsed.

Approximate size of hard copy application

How to complete this information

In the space provided, record the number of volumes expected for each Module of the dossier.

Using the check boxes provided indicate whether the volumes contain double-sided pages and whether the number of volumes recorded includes individual patient data.

While it is not expected that an exact figure can be provided, the number of volumes estimated should not significantly differ from the actual number included in the dossier. Where the application differs in scope or scale from that described in the PPF and the TGA agrees to proceed with evaluation, the TGA will need to reassess resources and may need to adjust milestone dates accordingly.

Further information

Where individual patient data will not be included in the dossier, a statement about the availability of the data must be provided in Module 1.9 of the dossier.

Applicants can provide individual patient data in the electronic copy of the dossier only. See Module 1.9 in CTD Module 1 for more information.

Record the submission ID numbers of related applications that are currently under evaluation in the left column. In the right column, describe the related application (including application type), and where possible the relationship to the proposed application.

Where it is not possible for the proposed application to proceed until the related application is completed, the TGA will advise the applicant in the Planning letter of a revised application lodgement date.

Applicants should defer PPF lodgement where there is a related application with the TGA whose outcome is critical to the processing and evaluation of the proposed application.

A PPF seeking a variation to a product that has not yet been registered cannot be accepted as it cannot be assumed that the application to register the product will be approved or approved for the proposed indication, strength etc. For information on concurrent applications, see Part 4.3.7 of Prescription medicine registration process.

Resubmission

How to complete this information

Select this check box if the PPF relates to:

  • a PPF that was lodged previously and found to be non-compliant with section 9D or section 23 of the Act
  • an application that was lodged previously and found to be non-compliant with section 9D or section 23 of the Act
  • an application that was previously withdrawn at any stage of the submission process
  • an application that was previously rejected by the delegate.

Where the check box has been selected, provide the original submission ID.

Applicants must include in the 'Overview of application' section details on how they have addressed issues identified in the previous application.

What else do I need to do?

The Planning letter, issued if the TGA considers the PPF complete and acceptable, will advise if any additional actions are required of the applicant. Applicants should ensure that any and all actions are addressed.

Section 31 request response period

How to complete this information

Select the check box for the preferred response period for the consolidated section 31 request for information, should one be issued: 30 or 60 calendar days. For information on this phase of the submission process, see sections 5.3 and 5.4 of Prescription medicine registration process.

Applicants must select either 30 or 60 calendar days.

What else do I need to do?

Once the Planning letter is received confirming the milestone dates for the application, applicants should ensure they have sufficient and appropriate resources available to meet the nominated response time.


Footnotes

  1. A PPF may be lodged if the trade name is not yet confirmed. However, the proposed trade name must be confirmed before lodgement of the dossier so the necessary labels, product information documents, and other materials can be included. If necessary, applications for additional trade names can be lodged following registration.

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