prescription medicines electronic lodgement · prescription medicines electronic lodgement system...

Prescription Medicines Electronic Lodgement System

(PREMIER)

User Guide

Prescription Medicines Electronic Lodgement System (PREMIER) User Guide

TABLE OF CONTENTS 1 Navigating the Prescription Medicines Electronic Lodgement facility........................... 3

1.1 Navigation from the TGA Online Services Home Page..................................... 3 1.2 Data Entry and Field Types ................................................................................ 4

2 Single Medicine Product Application......................................................................... 7 2.1 Applicant Details ................................................................................................ 8 2.2 Application Details ............................................................................................. 8 2.3 Provisional Record Details ................................................................................. 8 2.4 Route of Administration ................................................................................... 12 2.5 Container Details .............................................................................................. 12 2.6 Sterility Details ................................................................................................. 13 2.7 Ingredient Details.............................................................................................. 14 2.8 Pack sizes and Shelf Life Details...................................................................... 16 2.9 Manufacturer Details ........................................................................................ 17 2.10 Validate Application ......................................................................................... 23

3 Additional Application Features ............................................................................... 23 3.1 Edit Application ................................................................................................ 24 3.2 View and Print Entire Application.................................................................... 24 3.3 Draft a New Copy of that Application.............................................................. 24

4 Composite Pack Product Application ....................................................................... 25 4.1 Sterility Details ................................................................................................. 25 4.2 Components details ........................................................................................... 26

5 Submissions .............................................................................................................. 28 5.1 Creating Submissions........................................................................................ 28 5.2 Submission Details............................................................................................ 30 5.3 Submission Details Questions........................................................................... 31 5.4 Supporting Data ................................................................................................ 32 5.5 Electronic Documents ....................................................................................... 32 5.6 Authorised Officer Details ................................................................................ 33 5.7 Lodging a Submission....................................................................................... 33 5.8 Declarations ...................................................................................................... 34 5.9 Fees and Payment ............................................................................................. 35 5.10 Cover Sheet ....................................................................................................... 36

6 Viewing and Editing Applications and Submissions................................................ 37 6 Viewing and Editing Applications and Submissions................................................ 38

6.1 Viewing and Editing Applications.................................................................... 38 6.2 Viewing and Editing Submissions .................................................................... 39

Appendix 1: Code Tables.................................................................................................. 41 Appendix 2: Submission Details Questions...................................................................... 55 and Declarations................................................................................................................ 55

September 2007 of 56


1 Navigating the Prescription Medicines Electronic Lodgement facility

1.1 Navigation from the TGA Online Services Home Page Click the Prescription Medicines link

If you had not already been logged on to TGA Online Services you will be prompted for your user id and password. The Prescription Medicines (Premier) home page is displayed.

Under the Create heading are options to allow you to establish applications and submissions. Under the View heading are options to display lists or views of existing applications and submissions. From those views applications and submissions can be reviewed and edited and submissions can be lodged. Submissions and their applications that have already been lodged, including those submitted on paper “manually” are listed under the Lodged Submissions option. Those that are yet to be submitted are under the options Product Applications or Draft and Validated Submissions.



To apply electronically for a prescription medicines approval, firstly create one or more applications, and then create a submission in which to include them. That submission can then be lodged.

• Application - request to approve the registration of a new ARTG Entry – has application types, eg NCE, New Generic – has one and only one Provisional ARTG Record (PAR), that is, there is a

one to one relationship between an application and the eventual ARTG entry – each application relates to a separate and distinct good.

– Later versions will allow creation of applications to vary an existing ARTG entry.

• Submission - a sponsor’s request to have one or more applications approved. The applications in a single submission must relate to the same active ingredient be made at the same time, be covered by the one fee and go through the same workflow

– Category 1, 2, 3; SANs, SRNs, editorial PI changes, corrections to register information

There are two options for creating applications – Single Medicine Product Application or Composite Pack Product Application. It is necessary to select which is the appropriate option prior to creating the application as the type cannot be amended once the application is saved.

• A composite pack is a medicinal product where the primary pack or the container includes at least two kinds of medicinal products and does not contain any therapeutic devices. The medicinal products must be for use as a single treatment regimen. Examples include: a strip or blister pack containing tablets or capsules with differing formulations to be taken in a specified order, or a primary pack containing an active ingredient in one vial and a diluent in another vial, or a primary pack containing separate containers of different formulations for use as part of a single regimen of treatment.

• A composite pack will result in two or more components in the record. NOTE: This facility cannot be used to apply to register KITS. It may be used to apply for the registration of a medicine component of the kit but not of the kit itself or any device components of the kit. Refer to Section 7B of the Therapeutic Goods Act 1989.

1.2 Data Entry and Field Types The method of entering data into the various fields varies according to the nature of the field. Fields with a grey background do not allow text entry and must be populated using drop-down lists or database search. Fields that have a against them are mandatory, that is they must have a value entered into them in order for the application to be valid. You may leave them blank while drafting an application and still save the application.



1. Checkboxes, Radio buttons. Frequently there are check boxes that allow you to select one or more options by clicking on box adjacent to the required items. eg

If only one option is allowed then there are radio buttons where you can click on the button next to the option needed. eg

Refer Appendix 1 for values of Checkbox lists. 2. Numeric fields – allow entry of numbers only, not text. Do not enter negative numbers. eg

3. Free text entry fields – boxes that will allow you to type in (or paste) text. These will have varying limits to the amount of text that can be entered. eg

For lengthy fields, if the text entered exceeds the amount displayable in the text box, a vertical scroll bar will appear to allow you to move up and down the text. You should be aware that the ARTG database cannot store non-alphanumeric or formatting characters, such as carriage returns (Enter key), Greek characters or bullet points. While you may be able to insert these in this application form, they will not translate into the TGA internal systems, so it is better that you enter them as an unformatted text string rather than the system changing them and TGA staff then having to reinterpret and amend them. That is, only characters from the keyboard should be used, including punctuation marks such as full-stops, commas, semi-colons, colons, but without having paragraphs or starting on a new line. Arithmetic comparison operators such as ≤ can be replaced with the keyboard characters in sequence, eg <= . For example, rather than “Treatment of:

• α-warts; • angina; and • all.”

Enter it as: “Treatment of: alpha-warts; angina; and all.” separating the bullet points with semi-colons. Where the bullet points were to be sentences or lengthy phrases use an asterisk in place of the bullet (and don’t start each on a new line). Instead of using carriage returns for a new paragraph, use four spaces before the next sentence.



Free text fields have a character limit corresponding to the length of the text field available in the database in which the record will be eventually stored. These lengths were determined in the database design to be sufficient to store the text required for the fields in most cases, but if not then please abridge the text as best you can to fit the field, incorporating as many key fields as you can. The text of the data item in supporting documentation, such as Product Information, should not be abridged to correspond. 4. Drop-down lists. Fields that can only be entered by choosing an item value from a drop-down list which displays values from the TGA Code Table for that field. Refer Appendix 1 for values that will appear in drop-down lists. Eg

5. Combo boxes. These fields are a hybrid of the above two types, in that the value for the field can and should be selected from the drop-down list but you have the capability of typing the necessary value into the field if it cannot be found on the drop-down list. Should you do so, a warning message will be displayed next to it that the value has not come from a code table, but the application can still proceed. Eg

6. Search result from a database. Similar to drop-down list boxes, Ingredients and Manufacturer names are found by searching a database rather than selecting from a drop-down list.

Eg Multivalue tables. Some fields allow more than one entry. For example there can be many ingredients or many pack sizes. In these cases it is necessary to add each required entry one at a time to the multientry field. Some of these data items have more than one field associated with them, eg pack size has both the pack size and poison schedule available for each row of the table. There is no limit to the number of rows that can be added. To remove an entry, click the checkbox(s) in front of the item to be removed (a trash can icon will appear next to it) then click the Remove button.



Saving At any point where data has been entered you can save your work and continue to edit or save and close the application and return later. Deleting Applications and Submissions can be deleted at any point after they have been created, until they are Lodged. To do so, open the application or submission, edit it and then press the Delete button that will appear. You will get a warning to the effect that you are about to delete the document permanently and on pressing OK the document will be deleted. Deleting a submission does not delete the included applications. Those applications will become available for inclusion in another submission.

2 Single Medicine Product Application Choosing this option displays a scrollable application page which contains a variety of the abovementioned fields allowing either free-text entry or selection from either drop-down lists or from the TGA databases.

Client reference (free text) The sponsor or agent can insert an internal company reference such as a file number or a naming convention that will assist sponsor staff to identify this application from others in different views. This reference is not displayed to the TGA staff at any stage, before or after lodgement.



2.1 Applicant Details Applicant name The system displays the full name of the sponsor/agent staff member who has logged on. Sponsor name (drop-down list) This defaults to the sponsor details of the staff member who has logged on. Generally only one sponsor name is available unless logging on as an agent with a relationship to several sponsors.

Sponsor address (drop-down list) The sponsor must provide the correct address relevant to the registration of the product in this application where all correspondence will be directed. Sponsor preferred billing address (drop-down list) The sponsor must provide the preferred billing address relevant to the registration of the product in this application.

2.2 Application Details Application Status All applications have initially a Draft status. When drafting is complete, or even when only partially complete, the Validate button can be pressed. If the system finds all mandatory fields are complete then the status changes to Passed Validation. Only Passed Validation applications can be included in a submission.

Application Type (drop-down list) This defines the general nature of this application and the consequent fee. Only NCEs (which include new fixed combinations) and New Generics are currently available.

Type of submission to be included in (drop-down list) Only Category 1 or 2 applications can currently be selected. Eventually this will act as a checking mechanism to prevent Category 1 applications accidentally being included in Category 3 submissions and vice versa

2.3 Provisional Record Details Label Name (free-text) This is used to identify an ARTG entry uniquely to the database. The label name field text is the text that will appear on the Certificate of Registration and is for in-house identification purposes only. While it may not correspond exactly to the name of the product as it appears on the label on the pharmacy shelf, the intention is to distinguish why this ARTG Entry is separate and distinct from any other entry on the register. The standard convention also facilitates searching the database.



The standard format or convention is a text string comprising TRADE NAME active ingredient name strength dosage form container type within a limit of 150 characters. Eg VACCINOX therapine trihydroxide 50 mg capsule blister pack. Note that the trade name should be in UPPER CASE. The trade name you nominate must be unique. The name of the active ingredient, also known as generic name, is not sufficient as a trade name in itself. Each product on the ARTG must be clearly identifiable as a separate and distinct good. You should ensure that the product name (trade name) does not conflict with any other products marketed by your company or another company and complies with the Therapeutic Goods Order Number 69 a General Requirements for labels for medicines and the Best Practice Guideline on Prescription Medicine Labelling (November 2005) available from the TGA web site. The application form cannot do any validation checking on the format of the label name, apart from disallowing a blank entry, so it is important that the applicant enters this name/information carefully. There is a reminder of this convention in green text on the screen immediately below the field; the term generic name in that text is used in the sense of the active ingredient name. If you have not decided on a trade name to propose at the time of creating the application, use the actual words TRADE NAME as a surrogate. The Australian Approved Name (AAN) should be used for the generic where it has been approved, otherwise the name proposed for approval as an AAN. In most cases the above naming convention will result in a unique name for the product in this application, but there are often cases where it is necessary to supplement with additional text or adapt the convention, for example:



• a salt of the active drug substance is used in the product, the label name field should reflect this, depending on how the product strength is expressed (ie whether as the salt or equivalent amount of base or acid), eg.

TRADE NAME active drug hydroch oride or sodium strength dosage form container ltype

TRADE NAME active drug substance base or acid strength (as hydroch oride orl sodium) dosage form container type

• the product is a composite pack consisting of an active component and a diluent, the

label name should reflect the active ingredient as above

TRADE NAME active drug hydroch oride or sodium strength dosage form container type l

or TRADE NAME active drug substance base or acid strength (as hydrochloride or sodium) dosage form container type

With the words “with diluent container type (ampoule/vial/syringe, etc)” tagged at the end. If the diluent is known eg. Water for Injections or Sodium Chloride 0.9% then this can be used instead of the term diluent. • If the composite pack includes multiple active ingredients in the pack, include all the

component strengths in the label name.

TRADE NAME active drug hydrochloride or sodium of dosage form 1 strength of dosage form 1 dosage form of dosage form 1 active drug hydrochloride or sodium of dosage form 2 strength of dosage form 2 dosage form of dosage form 2 active drug hydrochloride or sodium of dosage form 3 strength of dosage form 3, dosage form of dosage form 3 container type

• If the composite pack contains more than three active ingredients the name does not

contain any of the active ingredients or their amounts. The label name field will be represented as

TRADE NAME dosage form composite pack

• If the product contains more than one active ingredient in the dosage form, all active

ingredients should be included in the label name

TRADE NAME active drug 1 strength and active drug 2 strength active drug 3 strength dosage form container type

or TRADE NAME active drug substance 1 base or acid strength (as hydrochloride or sodium) and active drug substance 2 base or acid strength (as hydrochloride or sodium) active drug substance 3 base or acid strength ( as hydrochloride or sodium) dosage form container type



• If and only if there is insufficient space in the free text field (150 characters available including spaces) to allow all the active ingredient names to be added then the label name should be

TRADE NAME dosage form container type

Confidentiality Flags (the four following radio buttons) Yes or No (default No) to determine whether the mentioned details should be visible to the sponsor or agent once the application is lodged and the product eventually registered. The applicant will need to include the details of the active ingredient and one manufacturer in order to be able to validate the application and include it in a submission, even if the full formulation or manufacturing details are not known. Biological/ Non-biological (one radio button) Select Biological if the product in which the active ingredient is a biological substance including antisera, antivenins, monoclonal antibodies and products of recombinant technology. This will affect the evaluation workflow path the application will follow once lodged and also the annual charge once the product is registered.

Proposed Therapeutic Indications (Free text, up to 4000 characters) A vertical scroll bar appears as the text box fills. Cutting and pasting from a word processing document is possible. Please refer to Section 1.2 3. Free text entry fields above for details of constraints relating to invalid characters and formatting in this field.

- Better if you interpret into a longer, bland unformatted text string as that is what TGA staff will need to do when processing the application.



Dosage form (Combo box) If possible, select from the drop-down list choosing the item that most fully describes the dosage form. Note that there are often more descriptive options to select, eg Tablet, gel-coated. If the required dosage form is innovative and not listed in the drop-down list, type it into the free text field. However, a warning will be displayed against the field if it is not from the drop-down list. This would make you aware of possible mis-keying of the text that could have been selected from the drop-down list. This warning will not prevent you continuing on if you have a new dosage form not on our code table.

2.4 Route of Administration Route of Administration (multi-value table) Using the Add button will allow you to select the route of administration from a code table. More than one route can be chosen but each must be added separately. Free-text entry is allowed if your route of administration is not in the code table. This will result in a warning that this route is not in the code tables but will enable the application to continue.

2.5 Container Details Container Type, Container Material (Drop-down lists) There are two fields to describe the container in which the product is to be supplied. Select from drop-down lists, however, data entry allowed if items can’t be found on the drop-down lists. Visual Id (free text, maximum of 150 characters) Describe the appearance of the medicine, including colour, printing, scoring etc.



ATC Code (optional entry, drop-down list, free-text not possible) Anatomic Therapeutic Chemical Classification (defined by the WHO). If the classification has not been determined this may be left blank. The field assists the TGA in classifying and querying products on the register so its inclusion if available would be of appreciated. Printed product material supplied (Multi-value table, drop-down lists, no free text) Select those items on the list that will be available for the product. List all printed or printable materials or literature, usually includes Product Information and Consumer Medicine Information. If there are other materials not found on the drop-down list that will be available they need not be itemised.

2.6 Sterility Details Is this product supplied sterile? (Radio button defaults to No) If Yes is selected then further fields appear to allow entry of the sterility method and other details. Some dosage forms, injections and eye drops for example, require sterility details to be entered in order for the application to pass validation. Sterility details (multi-value table) The part of your product that is sterilised can be entered as free text (optional). Sterilisation Methods are compulsory and must be selected from the drop down list. If a method is used that is not found on the drop-down list, contact TGA Online Services help desk; contact details as given on the TGA Online Services Home Page.



2.7 Ingredient Details Ingredients (Multi-value table, several fields in each row) The formulation is entered by adding multiple ingredients separately via a drop-down menu. Existing ingredients are chosen from the TGA database of ingredients. “New Ingredients” in this context means an ingredient that was not found after searching the TGA Ingredients database and should not be used until that search has been performed. Where a salt of an active drug substance is used, insert the actual ingredient used, that is the salt, rather than the actual substance to which it is equivalent, for example, record the ingredient Amoxycillin Trihydrate with a quantity of 123 mg rather than Amoxycillin 100mg. Later versions will allow recording of equivalents. TGA staff will insert such equivalents into the record from information provided in Module 3. Complete the ingredients table with the following. Existing ingredients (Radio button, default)



Ingredient role (Radio button) Choose whether the ingredient is an Active or Excipient or Proprietary (proprietary ingredients implicitly have an excipient role, contact the Pharmaceutical Chemistry Evaluation Section if you have a case where the proprietary ingredient has an active role). Ingredient Name: database search An existing ingredient can only be selected from the results of a database search. Only ingredients with Australian Approved Names (including approved biological names) are available from the database. Press the Search button and a search dialog is displayed. Where the same ingredient is used in two different aspects of the product it may be listed twice in the formulation. Ingredient Search Searching for an ingredient is generally done by name, entering some or all of the string of characters in the ingredient’s name and pressing Search. A wildcard (*) can be used to replace trailing text in the search string if you only want to search for part of a word. Select the ingredient required from the search results, by clicking on it so that it is highlighted, then press OK. You will then return to the previous dialog. If the ingredient is not listed in the results then reduce the characters in the text string and try again. You can even go as far as, for example, only entering the initial letter and the * wildcard and searching. Ingredient Units (Drop-down list) Units of measurement. Note that, for example, Milligrams is listed last in the list of Milligram-related units. Similarly Millilitres etc. A “unit” of Quantity Sufficient (QS) is available such as for where the ingredient is used to make up fill volumes, or pH levels or ink traces.



Quantity Options (Radio buttons) This defaults to Ingredient Quantity. Enter the amount of that ingredient in the formulation in the units specified. On rare occasions it may be necessary to give the quantity as a range of possible values. If so, choose Quantity range, select the range option then enter the numeric from/to values. This version does not allow for leaving the quantity field blank even when the Units field is QS (Quantity Sufficient). Until this is corrected use the value of 0 as a quantity for “QS” ingredients. Additional Information (Free text) Allows the entry of explanatory description, eg fill to, or pH to be made up. Where an ingredient is used twice, such as in the core and in the coating of a tablet the use to which each instance is put should be stated here. New Ingredients (Radio button) It is possible, especially for NCE applications that the required ingredient is not yet on the TGA Ingredients database. If so, and only after the appropriate searching has been done to see if the ingredient exists that you choose the New Ingredient option and another dialog box opens allowing free text data entry of the ingredient name you propose to be the Australian approved name.

2.8 Pack sizes and Shelf Life Details Pack sizes (multi-value tables) Enter one at a time the multiple free text pack sizes and their anticipated poison schedule using the dialog box.

Shelf life details (drop down lists) Select the shelf life, temperature, and conditions from the comprehensive drop-down lists. Additional information relating to shelf life, such as further conditions of storage can be entered as free text to a maximum of 500 characters.



2.9 Manufacturer Details Existing Manufacturers are added one at a time by searching the TGA manufacturers database. “New manufacturers” in this context means a manufacturer that does not yet have a licence or clearance and cannot be retrieved by the existing manufacturer search. The “New Manufacturer” option should not be used until that search has been performed. Note that evidence of requests for GMP clearance of new overseas sites is required in Module 1 of your data and a statement to this effect will be required in this lodgement process.



Existing Manufacturers (Radio button & multi-value tables) The following drop down search dialog box appears in the TGA Manufacturers Database after selecting the search button. Select either Australian or Overseas Manufacturer. Australian Manufacturers Search by selecting either Licence Id, Manufacturer Id or Manufacturer Name and then typing some or all of the string of characters in the search choice and pressing Search. You can also use * (wildcard) to search for incomplete words but it is not permitted when searching by Clearance ID. Select the manufacturer found from the search results and press OK. The address will be automatically populated if that manufacturer has only one site on the TGA database, however, if there is more than one site then use the drop down list to select the street address of the site being used in this instance.

Overseas manufacturers The full clearance number is required to be entered as the search parameter, no wild card searching or partial search strings are possible. When the search displays the record select it and press OK. The manufacturer and its addresses will be displayed on the first dialog as for Australian manufacturers.



Manufacturing Steps A list of Steps of Manufacture with checkboxes is displayed. Check the appropriate boxes, at least one, for each manufacturer. The manufacturer may be licensed to perform a number of steps for the sponsor and for the dosage form. Using the checkboxes, select only those steps that this manufacturer will undertake for this product. Note that the system does not correlate the steps you select against those for which the site has been cleared for the dosage form so it is important to select the correct steps to avoid queries later in the evaluation process.

The steps that are available for prescription medicines applications are: Active material manufacture Manufacture/synthesis of active pharmaceutical ingredient (API), Purification of API

Assembly Assembly of kits, composite packs, etc

Labelling Labelling only

Manufacture and/or maintenance of master cell bank and/or working cell bank Manufacture and/or maintenance of master cell bank and/or working cell bank - Manufacturing steps specific to certain biologicals

Manufacture of diluent Manufacture of diluent (supplied as a component of a composite pack consisting of

diluent and generally powder for injection and/or other components. However, if the diluent is registered independently as a separate product, then should use Manufacture of dosage form.)

Manufacture of dosage form Manufacture of dosage form (includes manufacture of components of composite packs

but excluding diluents). The manufacture of bulk blend, pre-mixes or other intermediate product is included under this step.

Manufacture of Human Serum Albumin Manufacture of human serum albumin (manufacturer of any other excipient should not be

listed)



Manufacture of port system and plastic bags For large volume parenteral administration, or as drainage bags, eg of peritoneal dialysis solutions

Packaging and labelling Primary packaging and labelling

Release for supply Release for sale/supply of finished products

Secondary packaging Secondary packaging (means any packaging, repackaging, labelling, over-labelling or

supplementary labelling where the medicine/device is already in the primary container and that package is not opened, breached or modified in the secondary packaging process)

Quality Control Quality control testing of finished products (includes all types of routine product testing

including sterility and other biological tests such as bacterial endotoxin/pyrogen)

NOTE: This step is a more generalised description of the four Testing … steps described below. Wherever possible, only use one or more of those specific steps rather than Quality Control. In the future, Quality Control will not be available as a choice.

Sterilisation Sterilisation of API, excipients, dosage form (final or intermediate), container or container

components (use this only if the site is specifically doing sterilisation only, eg as a contract manufacturer; otherwise, it is assumed "sterilisation", where necessary, is undertaken by whomsoever makes the dosage form or the API)

Syringe manufacturer Syringe manufacturer

Testing biological Testing for biological activity (when this is the only step done)

Testing chemical and physical Chemical and physical testing only of finished products

Testing microbial testing Microbial testing only of finished products [Use only if a site is nominated specifically for

certain tests for routine quality control purposes; otherwise, use Testing Biological.]

Testing sterility Sterility testing only of finished products



Note that: • Finished Product Manufacture is not available as a step. One or more of the

relevant steps above should be used to more specifically describe Finished Product Manufacture, eg Manufacture of dosage form, Packaging and labelling, Testing chemical and physical and Release for Supply.

• API intermediate and starting material manufacturers need to be stated in the dossier but are not required on the ARTG and hence should not be included in the application. GMP clearance is not required for such manufacturers.

New Manufacturer (Radio button) If a new site is not yet on the TGA database, for example the licence or clearance application is in progress, then select New Manufacturer, and enter the details of the site. Overseas sites need to have a postal or zip code entered in the Postcode field. This option should also be selected for an existing manufacturer with a new site, after checking that the location of the new site is not listed in the drop-down list after having selected the existing manufacturer using the database search.



2.10 Validate Application The application needs to be validated after you have completed filling it in. Scroll to the top of the page and press the Validate button. This checks that all compulsory fields have been entered. If there are no errors the application status will change to “Passed Validation” and can now be included in a submission. An error box with the validation errors as hyperlinks to the recalcitrant fields is displayed. Whilst there are error messages the application status will remain “Draft”.

3 Additional Application Features The application is saved on validation but remains open for additional application features such as viewing, editing, printing and copying.



3.1 Edit Application To review and make any changes press the edit button. Any amendment will change the status back to “Draft” and the Validate button will need to be pressed again.

3.2 View and Print Entire Application This produces a print preview of the full application. The completed application with the final status should be printed for inclusion in Module 1.

3.3 Draft a New Copy of that Application Frequently it is necessary to create a suite of similar applications, for example several strengths of the one medicine or differing dosage forms or containers. Use the New Draft Copy button to duplicate the application. The only difference between the copy application and the original is that the label name will have the text “Copy of” prefixed. The new application should be edited to correct the label name to reflect the different product characteristics and the relevant fields, such as container type, dosage form or ingredient quantities amended. Note that any errors in the original will be reproduced in the copy. If a correction is then made in the original the same correction will need to be made to each of the copies – there is no automatic update.



4 Composite Pack Product Application The initial details for completion for the composite pack product application, from client reference up to sterility details are the same as for Single Medicine Product Applications.

4.1 Sterility Details The sterility question is worded differently for the composite pack application. Each component may be sterilised and that information will be able to be entered later in the application but at this stage information is sought on whether the whole product is sterilised as well, such as for theatre packs. If only the components are sterilised leave this option as No.



4.2 Components details For the composite pack product application to pass validation at least two components must be added.

Note the warning. If the all the details of the component, from dosage form to shelf life, including its formulation (at least one ingredient), can’t be entered then when you press the Insert button, validation errors will be displayed and there will be no option to Save unless those errors are cleared (ie all compulsory fields for the component have been added). Enter a component description that differentiates this component from the other, eg Active tablet or Diluent. The remaining fields are completed as for Single Medicines Application.



The sterility question “Is this component sterilised?” allows recording of the sterility method for this component independently of that used for any other component or the product as a whole. If the component does not have an shelf life independent to that of the whole product answer No to the question “Does this component have a shelf-life different to that of the whole product?” and the shelf life fields will disappear. Pressing Insert will cause the component to be validated. If no validation errors are reported then the component will be inserted and the second or subsequent component can be added. Then manufacturer details can be added as for Single Medicines Application and the application can be validated in its entirety, printed, saved, copied as for Single Medicine applications.



5 Submissions

5.1 Creating Submissions Once all the required applications have been created they can be included in a submission. Applications that can be included in a single submission must all have:

- the status of “Passed Validation” - the same sponsor (relevant in the case of agents) - the same active ingredient - the same submission category as the submission being created.

From the Premier home page press the Submission link under the Create heading.



Sponsor (Drop-down list) In the dialog box, choose the sponsor (generally you will only see your own company name listed). Trade Name (Free text) Enter the trade name. Note that submissions are given an identifying name by the system by appending an uppercase version of the trade name you enter here with the active ingredient name. For example if you enter a trade name here of Amok and the active ingredient is amoxycillin then the submission will be listed in views as AMOK-amoxycillin. If you have a separate submission for the same trade name and active combination, eg if earlier you had applied for tablets and now your applying for capsules then it is useful to put the dosage form into this text (or strengths/s or container etc), eg Amok capsules. Then the system will have separate names so you can more readily identify in the Lodged Submissions view which is which, eg AMOK CAPSULES – amoxycillin and AMOK TABLETS – amoxycillin. Type of Submission (Drop-down list) Nominate the category of submission, from the drop down list. Common Active Ingredient Name (free text or Find button) Enter the ingredient which is the common active ingredient for all the applications to be included. The Find button will display a list of active ingredients that exist in all your validated applications and hence are possible candidates for a submission. Press OK. The submission screen opens up as a scrollable page containing a number of fields. If there are a number of common active ingredients, eg for multivalent vaccines, then choose the one that best identifies the submission and its applications. Client reference (Free text)



Allows the applicant to give a reference for this submission internal to the company, such as a file number or a naming convention that will assist staff to identify it in the views. This reference is not displayed to the TGA staff at any stage, before or after lodgement.

5.2 Submission Details Echoes the details entered in the dialog box. The submission name has been formed by concatenating the trade name (automatically upper-cased) with the ingredient name.

Submission Purpose (Free text) Type in a brief reason for this submission, something similar to what you may have written in the opening paragraph of a covering letter. Applications This is a list of all the applications that meet the criteria of the first dialog box, above, ie those for the ingredient and sponsor and submission type that have passed validation. They are not actually included in the submission until they are selected by clicking on them and they consequently get a blue highlight. They may all be included though it is not necessary to do so. Note: Fixed combination products are to be submitted separately to single entity products which happen to share one of the active ingredients of the fixed combination.



Fee Category Until one is chosen the Fee Category remains blank. If applications of varying types are selected then the Fee Category will display the highest Fee Category of those types.

5.3 Submission Details Questions A series of questions is asked that must be answered using the Yes/No radio buttons. Sometimes answering Yes to a question may require an additional Declaration to be made on lodging the submission (see below). Sometimes the question requires that you give some details in the Submission Details Questions Response field. This is a free text field at the end of the Submission Details Questions. Responses to more than one question can be included in this one text box. You may also include any comments or additional information you feel may be relevant to the application.

The full set of Submission Details Questions is included in Appendix 2 “Submission Details Questions and Declarations”



5.4 Supporting Data

Will hardcopy supporting data be submitted? (Yes/No radio button) The default is Yes. If you answer No then you will be required to provide a reason in a text box that will appear. Will hardcopy supporting data be submitted as bound volumes/ring binders? (Yes/No radio button) Normally if there is a significant amount of supporting data, it is provided to the TGA as volumes of data in binders. Small amounts of data may be simply attached to a covering letter. This question allows you to record which option will be taken for this submission. The default is Yes and allows you to record the number of volumes and their total pages and the number of copies thereof, broken down by Module. Note that the amount of data for Modules 5.3.1 and 5.3.2 needs to be separately itemised. If you answer No it allows the recording of just the number of pages again broken down by Module. Note that these tables of data quantities should be entered as integers and that there is no arithmetic checking of quantities performed by the system. The Pages column is optional, but please enter the number of pages if you are aware of the page count.

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5.5 Electronic Documents It is possible to attach electronic files from your system to the application. Up to 20 Megabytes can be received by the TGA this way.

September 2007


For example, you may wish to attach the Product Information and Consumer Medicine Information this way. The function asks you for a title and description (both free text) of the document and then using the Browse… button allows you to navigate through your network using the usual Windows navigation protocol.

5.6 Authorised Officer Details

Enter as free text, the name and contact details for the staff member of the company who will be lodging the submission. After completing the submission form you have the option of saving it for later validating and lodging by a Submitter, validating it or it can be Lodged immediately (if you have Submitter access). Validate and Lodge both check that all compulsory fields have been completed, that is Lodge performs the validation too.

5.7 Lodging a Submission. Open the submission and press Edit then press Lodge. The system explains that there are three steps to be completed. If you are unable to complete all three steps then you will need to cancel and repeat all three steps when you next attempt to lodge the submission. You are unable to save details of a partial lodgement, eg the declarations will have to be flagged again when you lodge again.



5.8 Declarations

A series of statements is displayed. The response to each defaults to No but each will have to be changed to Yes if the lodgement is to proceed. Each statement should be read carefully before responding. After you have responded to each declaration, click Next to proceed to the Step 2. Note that some declarations in future versions may allow a Not Applicable response hence the annotation in the screen header. The full set of Declarations is included in Appendix 2 “Submission Details Questions and Declarations”



5.9 Fees and Payment The Submission Type and Fee Category are repeated. Radio button options are provided for you to nominate the proportion of fee to be paid. The default is 100% and the full amount of the 100% fee is displayed. If you change the option to 75% then the fee amount will change accordingly. Where the total fee payable for the evaluation is greater than $100,000, then the AGRPM allows for companies to make a submission without payment. This may be exercised in two ways. You can choose the Please Invoice option in which case the system will create a Tax Invoice for the 100% fee. Or you may prefer to choose the 75% payment option, which will generate a Tax Invoice for the 75% fee. You may then retain that invoice without immediately paying. In either case payment must be made on receiving your acceptance letter after screening. The Other option is reserved for cases where a series of instalments has been approved. Note that if you responded in the Submission Question that this was a designated Orphan Drug then this step will be omitted by the system.

Pressing Next displays a Print Preview of the resulting Tax Invoice. Payment options are provided. The credit card option cannot be used for amounts over $15,000. This Tax Invoice must be printed and a copy forwarded to the address shown along with the cheque if any. Note that if you subsequently Cancel the lodgement process on the remaining screens then this Tax Invoice should not be used. A new one, with a new Invoice number will be generated next time you go through this lodgement process which will match up with the submission id when the payment arrives at TGA.



5.10 Cover Sheet

Step 3 is the production of a cover sheet. No fields are required to be entered for this step. Details of the submission are reproduced, a print preview displayed and it can then be printed and signed to be included with the submission’s hardcopy supporting data.



A final confirmation screen appears. Press Finish and the submission will be transmitted to the TGA’s internal workflow systems — a progress bar appears while this occurs. Within half an hour the submission will appear in your View Lodged Submissions list. Note that if you Cancel at this point then you should not use the Tax Invoice and Cover Sheet that have been printed. When you Lodge again new versions will be produced which should be used as they will match the submission when it arrives in TGA.

6



Viewing and Editing Applications and Submissions

6.1 Viewing and Editing Applications

Select the Product Applications option under the View heading.

A view listing all the applications not yet included in a submission is displayed. It gives the status, name, type and reference details as well as audit stamps of the last modification. To return to the main Premier menu use the Home button. If there is more than one screenful of applications available to list use the Next and Previous buttons to move down and up the list. Do not use the browser’s Back button. The Refresh button will update the list if another application is created (by another staff member) while you are browsing this view.



Clicking on the Status column for an application opens it in browse mode. Action buttons are available if you need to Edit or Copy the application. Once in Edit mode the application operates in the same manner as when creating an application.

6.2 Viewing and Editing Submissions

Select the Draft and Validated Submissions option under the View heading.



Submissions are listed with their status, reference, trade and active ingredient names, as well as audit stamps of the last modification. Click on the Status column to open the submission in browse mode. It can then be edited as necessary. Once in Edit mode it can also be Lodged.



Appendix 1: Code Tables Values in Drop-down lists for Applications, as at 13 August 2007

Container Material Al Al laminated with LDPE/paper Al laminated with PE/paper Al laminated with PVC/paper Al/Al Composite plastic laminate Epoxy-coated Al Glass Glass Type I Clear Glass Type I Coloured Glass Type II Clear Glass Type II Coloured Glass Type III Clear Glass Type III Coloured HDPE LDPE Other composite material Other plastic laminate/Al PA/Al/PVC/Al - polyamide-aluminium foil-polyvinylchloride/aluminium foil PCTFE (Aclar)/AI PE Plastic PP PP/Al PVC PVC-coated Al PVC/Al PVC/PCTFE (Aclar)/Al PVC/PE PVC/PE/PCTFE (Aclar)/Al PVC/PE/PVDC/Al PVC/PVDC PVC/PVDC/Al PVC/PVDC/PE Steel Tin-plated steel Uncoated-Al Container Type Aerosol Can Aerosol Can, Metered Dose Aerosol, Pump Actuated Aerosol, Pump Actuated Metered Dose



Ampoule Bag Blister Pack Bottle Buffer Pack Bulk Container Carton Cartridge Compact Dial Dispenser Pack Dispenser Pack Drum Gas Cylinder Inhaler, dry powder Inhaler, Metered Dose Jar/Can Multiple container types Not Applicable Puffer Pack Sachet Shrink Wrap Spray, elasticity driven Strip Pack Syringe Tea Bag Tube Vial Vitrella Wrapping Dosage Forms Application Bar, soap Block Capsule Capsule, enteric Capsule, hard Capsule, modified release Capsule, soft Cement, medicated Collodion Cone, dental Cream Diluent, not applicable Dressing, medicated Drug delivery system Drug delivery system, intrauterine Drug delivery system, ocular Drug delivery system, transdermal Drug delivery system, vaginal



Ear Drops Ear Drops, emulsion Ear Drops, powder for Ear Drops, solution Ear Drops, suspension Enema Essential Oil Extract Extract, concentrated Extract, dry Extract, liquid Extract, soft Eye and Ear Drops Eye and Ear Ointment Eye Drops Eye Drops, emulsion Eye Drops, powder Eye Drops, solution Eye Drops, suspension Eye Ointment Gas, medicinal Gel Gel, eye Gel, modified release Granules Granules, effervescent Granules, enteric-coated Granules, modified release Gum, chewing Herb, dried Implant Implant, radioactive Inhalation Inhalation, conventional Inhalation, powder for Inhalation, pressurised Injection Injection, concentrated Injection, diluent for Injection, emulsion Injection, intravenous infusion Injection, modified release Injection, powder for Injection, solution Injection, solvent for Injection, suspension Insufflation Large Volume Parenteral Liniment Liquid, multipurpose



Lotion Lotion, powder for Lozenge Lozenge with integral application Mouthwash Nasal Drops Nasal Drops, emulsion Nasal Drops, powder for Nasal Drops, solution Nasal Drops, suspension Ointment Oral application Oral Liquid Oral Liquid, emulsion Oral Liquid, powder for Oral Liquid, solution Oral Liquid, suspension Oral Liquid, syrup Pad, impregnated Paint Paint, concentrated Paint, powder for Paste Pastille Patch, dermal Pessary Pessary, compressed Pessary, modified release Pessary, moulded Pessary, shell Pill Powder Powder, dusting Powder, dusting, sterile Powder, oral Scratch test unit Solution Solution, concentrated dialysis Solution, dialysis Solution, irrigation Solution, powder for Solution, powder for dialysis Solution, powder for irrigation Spray Spray, nasal Spray, pressurised Spray, solution Spray, suspension Stick Stick, lip



Stick, uretheral Suppository Suppository, compressed Suppository, moulded Suppository, shell Suspension Suspension, powder for Tablet Tablet, chewable Tablet, dispersible Tablet, effervescent Tablet, enteric coated Tablet, film coated Tablet, gelatin coated Tablet, modified release Tablet, multilayer Tablet, orally disintegrating Tablet, soluble Tablet, sugar coated Tablet, uncoated Tea Tincture Wafer Wipe, medicated Manufacturing Steps Active material manufacture Assembly Labelling Manufacture and/or maintenance of master cell bank and/or working cell bank Manufacture of diluent Manufacture of dosage form Manufacture of human serum albumin Manufacture of the port system and plastic bags Packaging and labelling Quality Control Release for supply Secondary packaging Sterilisation Syringe manufacture Testing biological Testing chemical and physical Testing microbial Testing sterility Printed Material Supplied Bulk Carton Label Bulk Label Blister Foil Bulk Shipping Label



Consumer Medicine Information Container Label Labels Between Primary Pack And Container Package Insert Primary Pack Label Product Information Product Wrapping Promotional Material Syringe Tray Label Poison Schedule Not Scheduled after consideration by Committee Not scheduled. Not considered by committee (S3) Pharmacist Only Medicine (S4) Prescription Only Medicine (S8) Controlled Drug Routes of Administration Breast milk transfer Buccal Dental Epidural Extracorporeal Circulation - Haemodialysis Hard Surface Disinfectant Infiltration Inhalation Instrument Grade Disinfectant Intraarterial Intraarticular Intracardial Intracavernosal Intracavitary Intracisternal Intracranial Intracutaneous Intradermal Intradiscal Intraepidermal Intralesional Intramammary Intramural Intramuscular Intraneural Intraocular Intraosseal Intraperitoneal Intrapleural Intrasynovial



Intrathecal Intratracheal Intratumour Intrauterine Intravenous Intravenous Bolus Intravenous Infusion Intravesical Intravitreal-Within The Vitreous Cavity Of The Eye Mucosal Nasal Nasogastric Ophthalmic Oral Oral Application Oromucosal Otic Percutaneous Periaticular Peridural Rectal Sterilant, Device Subarachnoid Subconjunctival Subcutaneous Sublingual Submucosal Topical Transdermal Urethral Uterine Vaginal Shelf Life Conditions Avoid exposure to direct sunlight Avoid Storage in Direct Sunlight or Heat. Discard 4 weeks after opening Do not expose to extreme temperature Do not Freeze Do not freeze, do not dilute Do not Refrigerate Do not refrigerate. Protect from light. Do not Shake Do not Shake, Protect from Light Do Not Use if Colour Changes Do Not Use if there is Crystallisation Do Not Use if there is Precipitation Keep away from heat including sunlight Keep Container Tightly Closed/Airtight Protect from direct sunlight and moisture



Protect from direct sunlight. Protect from excessive moisture Protect from Frost Protect from frost and light. Do not freeze. Protect from Heat Protect from heat and moisture Protect from Light Protect from light after opening Protect from light and moisture Protect from light and secondary x-rays Protect from light. Do not freeze. Protect from light. Do not freeze. . Protect from light. Store in a dry place. Protect from light. Keep container tightly closed. Protect from Moisture Protect from moisture. Keep container tightly closed. Protect from X rays Reconstituted solution shelf life see indications Reconstituted solution shelf life see label Refrig-do not freeze,Protect from intense light Refrigerate Refrigerate, do not freeze. Refrigerate. Do not freeze. Protect from light Refrigerate. Protect from light. Replace the cover firmly after use. Storage conditions as per the CMI. Storage conditions stated in Product Information. Store at room temperature Store in a deep freeze. Store in a Dry Place Store in dry place. Keep container tightly closed. Store in Original Container Store Upright Use only if solution is colourless Shelf Life Temperature Room temperature Store at 2 to 8 degrees Celsius Store at minus 80 degrees Celcius Store at or below 20 degrees celsius Store below 20 degrees Celsius Store below 25 degrees Celsius Store below 30 degrees Celsius Store below 4 degrees Celsius Store below 40 degrees Celsius Store below 8 degrees Celsius (refrigerate)



Store below minus 15 degrees celsius Store below minus 15 degrees Celsius (deep freeze) Store below minus 18 degrees Celsius (deep freeze) Store below minus 5 degrees Celsius (freeze) Store below minus 70 degrees celsius Store between 0 - 50 degrees Celsius Store between 10-25 degrees Celsius Store between 15-25 degrees Celsius Store between 15-30 degrees Celsius Store between 2-30 degrees Celsius Store between 2 - 23 degrees celsius Store between 2 - 25 degrees celsius Store between 4-30 degrees celsuis Store between 5 - 25 degrees celsius Store between 5 - 55 degrees celsius Store between 8-25 degrees celsius Store between 8 - 30 degrees Celsius Store between minus 10 - minus 20 degrees Celsius Store between minus 15 to minus 35 degrees celsius Store between minus 20 - plus 50 degrees celsius Store between minus 5 to plus 55 degrees C Store between minus 60 - minus 80 degrees Shelf Life Time 1 Month 1 Year 10 Months 11 Months 13 Months 14 Days 14 Months 15 Months 16 Hours 16 Months 18 Months 19 Months 2 Years 20 Months 21 Days 21 Months 22 Months 23 Months 24 Hours 25 Months 27 Months



28 Days 28 Months 3 Days 3 Months 3 Years 30 Months 31 Months 32 Months 4 Years 42 Months (3.5 Years) 44 Months 48 Hours 5 Days 5 Months 5 Years 50 Months 6 Months 6 Weeks 6 Years 7 Days 7 Months 8 Days 8 Hours 8 Months 9 Months Sterility Method Aseptic Handling Beta Irradiation Chemical Dry Heat Electron Beam Sterilisation Ethylene Oxide Filtration Gamma Irradiation Gas Plasma Sterilisation Glutaraldehyde Heat Killed Propylene Oxide Steam Units 100 milligram/millilitre 1/10 dilution Acid lacatase units Allergy Units/millilitre Alpha-amylase dextrinising unit Anti-thrombin unit anti-Xa activity International Units anti-Xa activity International Units/millilitre



Antigen unit Antigen unit/mL Becquerel Becquerel/milligram Becquerel/millilitre Billion colony forming units Billion colony forming units per gram Billion colony forming units per millilitre Billion organisms Billion organisms/gram Billion organisms/milligram Billion organisms/millilitre British Pharmacopoeial Unit British Pharmacopoeial Unit/gram British Pharmacopoeial Unit/mL Cell Culture Infective Dose 50 Cell culture infective dose 50/dose Cellulase unit Cellulase unit per gram Colony Forming Unit Colony Forming unit/gram Colony Forming Unit/millilitre D Antigen Unit D Antigen Units per millilitre Dextrinising unit per gram Dosage Unit not applicable Dose Unspecified Enzyme-Linked ImmunoSorbent Assay unit Enzyme-Linked ImmunoSorbent Assay unit/millitre Gigabecquerel Gigabecquerel/milligram Gigabecquerel/millilitre Gram Gram/gram Gram/litre Gram/millilitre gram/square meter Haemoglobin unit on the tyrosine basis per gram Haemoglobin units on the tyrosine basis Index of Reactivity /millilitre Infectious Units/millilitre International Opacity Units International Unit International Unit/ square cm International Unit/gram International Unit/litre International Unit/microgram International Unit/milligram International Unit/millilitre



Kallikrein Inactivator Unit Kallikrein Inactivator Unit/millilitre Katal Kilobecquerel Kilobecquerel/milligram Kilobecquerel/millilitre Kilogram Kilogram/litre Kyowa units Lactose unit Lime flocculation unit Lime flocculation unit/millilitre Lipase unit per gram Lipase units Litre Litre/litre Loomis unit Loomis unit/gram Loomis unit/millilitre Megabecquerel Megabecquerel/milligram Megabecquerel/millilitre Microgram Microgram/24 hour Microgram/actuation Microgram/gram Microgram/litre Microgram/millilitre Microgram/square centimetre Microkatal Microlitre Microlitre/gram Microlitre/litre Microlitre/millilitre Microlitre/square centimetre Micromole Micromole/litre Micromole/millilitre Milligram Milligram iodine/millitre Milligram per centimetre Milligram per Kilogram Milligram per square metre Milligrams I/millitre Milligram/24 hour Milligram/actuation Milligram/gram Milligram/litre Milligram/milligram Milligram/millilitre



Milligram/square cm Millilitre Millilitre/gram Millilitre/litre Millilitre/millilitre Millilitre/square cm Millimole Millimole/litre Millimole/millilitre Million colony forming units Million colony forming units per gram Million colony forming units per millilitre Million International Units Million International Units/millilitre Million organisms Million organisms per milligram Million organisms/gram Million organisms/millilitre Milliosmol/kilogram Mole Mole/litre Nanogram Nanogram/gram Nanogram/millilitre Nanokatal Nanolitre Nanolitre/millilitre Nanomole Nanomole/millilitre NIH units of Thrombin inhibited/centimetre squared Percent Percent volume/volume Percent weight/volume Percent weight/weight Pharmacopoeia Europe Unit Picogram Picogram per gram Picogram per milligram Picogram per millilitre Picokatal Plaque Forming Unit Plaque Forming Unit equiv 1000 mouse LD50 Plaque Forming Unit/millilitre Pock Forming Unit Pressor units/millilitre Protein Nitrogen Units/millilitre Quantity - Sufficient (QS) Thousand alpha-amylase dextrinising unit Thousand alpha-amylase dextrinising unit



per gram Thousand cellulase unit Thousand cellulase unit per gram Thousand colony forming units Thousand colony forming units per gram Thousand colony forming units per millitre Thousand haemoglobin units on the tyrosine basis Thousand haemoglobin units on the tyrosine basis per gram Thousand International Unit Thousand International Unit per gram Thousand lipase unit Thousand lipase units per gram Thousand organisms Thousand organisms/gram Thousand organisms/millilitre Thousand (Acid) lacatase unit Thousand (Acid) lacatase units per gram Tissue Culture Infective Dose 50 Tissue Culture Infective Dose 50/dose Titre Tuberculin Unit Tuberculin Unit per millitre Unit United States Pharmacopoeial Unit United States Pharmacopoeial Unit/gram United States Pharmacopoeial Unit/mL Unit/gram Unit/millilitre US opacity unit measured against the US standard (Acid) Lactase unit per gram



Appendix 2: Submission Details Questions

and Declarations New Chemical Entity and New Generic Applications Submission Details Questions (Yes or No answer required) Has this medicinal product been designated an Orphan Drug for the proposed indication? 2. Does this application depend upon the outcome of, or relate to, any other application currently under evaluation by theTGA? If YES, provide submission number(s)and/or file numbers in the Additional Details field below 3. Is the application in the EU Common Technical Document (EU -CTD) format? If No, prior approval must be obtained and the reference of that approval provided in Additional Details field below. 4. Are you requesting priority status for this submission? If Yes, include the reason in the Additional Details field below 5. Does the product contain Human Embryos or Human Embryonic Stem Cells or material derived therefrom? If Yes a declaration must be included in the Module 1. 6. Expert declarations and information about the experts have been included in Module 1. 7. Is this a literature based (bibliographic) submission? 8. Does the product contain or consist of Genetically Modified Organisms (GMOs)? 9. Does the submission make reference to a Drug Master File (DMF) or a Plasma Master File (PMF) or to an EDQM Certificate of Suitability (CEP)? If Yes, include relevant documentation in Module 1. 10. Is there one or more overseas manufacturer of the goods for which GMP clearance letters from the TGA have NOT yet been OBTAINED or REQUESTED to establish that the overseas manufacturers of the goods are of an acceptable standard? (NO PRODUCT MAY BE APPROVED WITHOUT GMP CLEARANCE FOR ALL SITES OF MANUFACTURE.) 11. Was there a pre-submission meeting or process? If Yes, provide a reference below in the Additional Details field. 12. There is a statement that Individual Patient Data, in the format that would be acceptable for submission in the EU or the USA, can be supplied, identifying if necessary any studies for which individual patient data are not available. 13. Details of the overseas regulatory status have been provided in Module 1. 14. A declaration on whether an application for the product has been rejected, withdrawn or repeatedly deferred in the USA or Canada has been included in Module 1.



15. A summary of a Bioavailability or Bioequivalence Study or justification for not providing biopharmaceutic studies, including references has been provided in Module 1. 16. Are there paediatric data/formulations for this product? 16A. If Yes, have details of these paediatric data/formulations been provided? If No, is there a formal justification as to why the product is not appropriate for use in children (in Modules 1 or 2)? 17. Do you give approval for the exchange of evaluation reports with other regulatory agencies for this submission? If Yes, specify particular countries or “All Countries” in the Additional Details field below. Declarations

Declaration Text Allowed

Responses I acknowledge that the Therapeutic Goods Act, 1989, provides for offences and penalties for making statements that are false or misleading in connection with an application for registration or variation of therapeutic goods.

Yes

I apply to register, or vary the entry in the ARTG for, the goods described in each of the applications in this submission and declare that the information provided in that electronic form and in the submission is, to the best of my knowledge, current and correct.

Yes

To the best of my knowledge, I certify that this submission is accompanied by such information and in the required format as will allow the determination of the applications (that is, complies with the current Australian Regulatory Guidelines for Prescription Medicines (ARGPM) for preparing applications to register medicinal products and any associated or supplementary guidelines).

Yes
