SOLTRADE User Guide for the electronic notification of Sole Trader Medicines in Australia
Version 1 18 March 2005
TGA Online Services
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Getting Started
Before you start Before you start, you must register your business or enterprise with the Therapeutic Goods Administration (TGA). This is done completing the Client Details form that is available at the TGA Online services web site. Upon receipt TGA will create a Master account for your organisation which will enable you to create user accounts to access the SOLTRADE system. Details concering account management and system security can be found in Appendix A. If you have already been issued a Client ID number and password to access TGA’s Online Service applications you may use your existing user name and password to access Soltrade.
Introduction
The SOLTRADE system is accessed through your Web browser and has been designed to be compatible with Microsoft Explorer version 6.0. As your organisation Administrator creates user accounts, each User will receive an E-mail containing their user name and password.
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Accessing the SOLTRADE system
Access to SOLTRADE is via your web browser at www.tgasime.health.gov.au/sime/home.nsf Select the SOLTRADE access line. The login screen will be displayed. Enter your login details. (Your login User Name and Password are as provided in your system generated email.).
Only users with appropriate username/password access will be able to access SOLTRADE, and users will only be able to access their own product notifications and records.
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The SOLTRADE Home Page is displayed as shown below. SOLTRADE Home Page
Navigating the screen
You can use the Up or Down arrow keys, the Page Up or Page Down keys, or the scroll bar at the right hand side of the screen to navigate up and down the screen.
Welcome tab
takes you to the SOLTRADE home page.
New Notification tab
brings up the Create a New Notification facility.
My Draft Notifications tab My Submitted Notifications tab The Task bar
lets you review and edit a Draft Notification.
shows the list of notifications that you have submitted, or lodged with TGA.
The Task bar sits below the “View” tabs and lists the various tasks either SOLTRADE or you can perform.
Welcome User accessing SOLETRADE
This lists the UserID of the person
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Add to My Favourites
This allows you to bookmark the SOLTRADE Home Page in your internet browser for future easy access.
Print this Page
This allows you to print the current view to your PC default printer.
Log out
When your session is completed, you should exit SOLTRADE by clicking on Log out. If you close SOLTRADE without logging out, you may remain connected to the database.
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CREATING A NEW NOTIFICATION Introduction The New Notification view brings up a fresh screen to input data. The View is divided into four areas: Your sponsor details (loaded from your User ID), Product details, Active Ingredient details, and Manufacturer details. Details requiring a response from you are marked with a red bullet . A question mark icon indicates that a help tip is available on the subject.
Australian Sponsor details
Your sponsor details are automatically included by SOLTRADE
Product details
Product details cover the identification of the product – its name, dosage form, and container type. Enter details in the boxes provided.
Product Name Click inside the bar and enter the product name as free text. On-screen help tip Export Only Click “Yes” or “No” using the radio buttons. On-screen help tip “For Export Only” means that this product, while manufactured in Australia, is not sold in Australia. This is the name for the Product as marketed in Australia.
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Dosage form Select a dosage form option from the drop-down list. You can select only one dosage form per product. If your product has more than one form (e.g. tablet and capsule), then you need to make a separate SOLTRADE notification for each dosage form. If the dosage form you require is not on the list, select the first option in the list, namely “Other”. A new box will appear, in which you can enter a dosage form.
Only use the “Other” option if it is unavoidable. On-screen help tip If the dosage form you require is not on the list, select “Other”. A new box will appear, in which you can type in a dosage form. If you have more than one “other” dosage forms, you must record separate SOLTRADE entries for each “other” dosage form product.
Container Type
You can select one or multiple container types for a single dosage form (e.g. tablets may be packaged in a bottle and a blister pack). Select a container option from the drop-down list and click on the Add Container Type button to add the selection to your notification. If the container type you require is not on the list, select the first option in the list, namely “Other”. A new box will appear, in which you can type in a container type. Then click on the “Add Other Container Type” button.
Only use the “Other” option if it is unavoidable. On-screen help tip If the container type you require is not on the list, select “Other”. A new box will appear, in which you can type in a container type. If you have more than one “other” container type, enter these individually and click on “Add Other Container Type”. Each “other” container type will be added to the list.
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Removing a selected container type
Select the container type to remove and click on the Remove Container Type button. Active Ingredients details
The active ingredients are selected from a drop-down list of substances that may be used as active ingredients in listed medicines in Australia. The drop-down list is accessed by clicking on the “ Click here to edit the Active Ingredients” hyperlink. On-screen help tip For the purpose of creating this transition record, if you are unsure about ingredient names, you can check the names against the TGA approved terminology for medicines. A copy can be downloaded from the TGA website at: http://www.tga.gov.au/docs/html/aan.htm
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Select Active Ingredients
Clicking on an alphabet in the listing takes you to the ingredients beginning with that character. Enter selections into active ingredient screen Select the line (1 to 5) that you wish to complete by clicking the relevant radio button. Click on the alphabet listing to display a list of ingredients beginning with your section. Scroll the list to find the ingredient and select by clicking the ingredient name. The selection will pass to the relevant line “Active ingredient name”. Click in the strength box and enter a value as free text. Scroll the Units drop-down selection list to find the relevant unit. Repeat the process for up to five active ingredients if appropriate. Apply Values applies the chosen active ingredient names, strengths and unit values to the product notification form and returns you to the notification screen. Close Window closes the active ingredient window without saving or applying the values, and returns you to the notification screen.
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Reset selected value
clears the selected active ingredient name and leaves it at the default “No ingredient selected”. You need to click on the radio button at the left to select the ingredient first.
Choosing an Active Ingredient
Use the radio buttons to enter the active ingredients in your product, from the list shown. The list is arranged in alphabetical order. Choosing an active ingredient automatically moves the radio button to the next line in readiness for the next entry.
If the list does not contain an active ingredient present in your product, use the “Other“ option that is available on the main notification form. The “other” active ingredient, its quantity and units are entered as free-text.. The form allows the entry of up to five active ingredients. For products with six or more active ingredients, you must enter the five that are present in the greatest quantity. To remove a selected active ingredient, click in the appropriate boxes and clear the name, strength, and units. Entering an active ingredient strength
The strength must be entered in numeric format.
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Choosing a strength unit
Choose a unit of measurement from the drop-down list to correspond with the strength of the active ingredient.
Potency for homoeopathic products can be expressed in terms of 1/10 dilution, 1/100 dilution, or 1/1000 dilution of the active ingredient. Manufacturer details The Manufacturer details identify which manufacturer is used to make the product.
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Manufacturer Name
For the purposes of issuing an interim product licence, you need only enter the name of one manufacturer, even if several manufacturers are involved. You can either select a manufacturer name with country or enter the name as free text. The Search option is recommended. Clicking on the Search button will activate a Search engine. Type in the name of a manufacturer, or words that you might expect to find in the manufacturer’s name, and click on Search. You can use a wildcard *, and search functions such as “And” or “Or” between words.
A list of companies with associated country that are known to TGA, that matches your search criteria, will appear. Select the manufacturer company name and country relevant to your product, and click on the “Add to Application” button to add this manufacturer to your notification and exit the search engine, or the “Cancel” button to exit without selecting a manufacturer.
If you choose to enter the name of the manufacturer as free text, you will have to specify it’s country of location. On-screen help tip Manufacturer Country For the purposes of issuing an interim product licence, only the name of the principal manufacturer manufacturing this product is required.
Select the country where the manufacturer is located from the drop-down list. To scroll quickly through the alphabet, click in the empty box or
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the down arrow, and type the first letter of the country name. On-screen help tip Saving your notification as a draft notification Submitting your notification To scroll quickly through the alphabet, click in the empty box or the down arrow, and type the first letter of the country name.
This button saves your notification as a draft that you can revisit and edit at a later time.
When you have completed creating or editing, this button will lodge your notification with the SIME server. A validation check is run on the form as part of the submit process. Non completion of required fields is displayed as a dialog message and will prevent submission of the notification. From the SOLTRADE Home Page, select “Review a Draft Notification”, or click on the “My Draft Notifications” tab at the top of the screen. A list of draft notifications appears.
Getting to your draft notifications
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Accessing a draft notification
Your draft notifications are listed in date and time order. Clicking on the little arrowhead next to “Date Created” in the title bar changes the order of listing. Moving the mouse cursor over the date created will highlight that notification. Click to select that notification for viewing and editing. Deleting a draft notification
Click on the tick box to the left of the draft notification in order to select it. Then click on the “Delete Selected” button. Deleting all draft notifications
You may select multiple draft notifications by clicking on their tick boxes. Alternatively, click on the tick box at the left of the blue title bar to select all draft notifications. Then click on the “Delete Selected” button.
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Accessing a submitted notification
From the SOLTRADE Home Page, select “View Lodged Notification”, or click on the “My Submitted Notifications” tab at the top of the screen. The Submitted Notifications screen appears.
Your submitted notifications are listed in date order. Clicking on the little arrowhead next to “Date Created” in the title bar changes the chronology of listing. Viewing a submitted notification
Moving the mouse cursor over the date submitted will highlight that notification. Click to select that notification for viewing. Copying a submitted notification to a new draft notification You may wish to copy or clone the details of a submitted notification into a new draft notification for editing. Click in the tick box to the left of the notification to select it. Then click the Copy Selected button. You will be prompted to enter a new product name for the draft notification you have created.
Your new draft notification can now be accessed in the My Draft Notifications view.
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Appendix A Access to make a Soltrade notification via the Web
The Strategic Information Management Environment (SIME) project is an initiative of the TGA to improve the way in which our regulatory information is managed. SIME establishes a secure environment for electronic commerce, electronic lodgement of applications for the notification of sole trader products in Australia. To gain access to the Soltrade notification system, Sponsors must complete a new 'Client Details' form if they have not previously supplied Client information to TGA. Upon receipt of the Client details form, TGA will provide secure access to the new system based on the supplied information. Please be aware, once the E business terms and conditions document is signed on behalf of your Company, it will be your responsibility to maintain the ongoing currency of this information. Steps for gaining access to the TGA SIME site for ∈ business 1. Complete the new "Client Details" Form, if you have not previously supplied Client information to TGA. Please note that with respect to Section C (Client representatives), staff or people in your organisation who will have electronic access to your information or can make an electronic application within SIME for entry on the ARTG are defined within the SIME User management system. This electronic access will be maintained within the SIME system. Information provided in the Client Detail Form relates to the organisational level only. 2. Complete the "E Business Access Form" Form" . Please note it is essential that the details for the organisation E-Business Administrator are provided, as this is the single contact between an organisation and TGA for E business. 3. Read the TGA E Business document, which describes the SIME security operational environment terms and conditions document "TGA E-Business Service Terms and Conditions" at Page 5. 4. TGA will use the information provided to create your Sponsorship record and your Business Administration Account.
∈
Please note, the ∈ Business Administration Account does NOT give the user access to TGA information. The account is established at the organisational level for your organisation to manage your own users.
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5. Upon creation of the ∈ Business Administration Account by TGA, your nominated EBusiness Administrator will receive an automatic E-mail from the SIME System containing the E-Business Administrator username and password. 6. Subsequent User Accounts created by the ∈ Business Administration Account will receive an automatic E-mail from the SIME System containing the User password. 7. The SIME web address is : www.tgasime.health.gov.au
TGA ∈ Business
The TGA SIME ∈ Business System ("the System") provides a browser based electronic online environment for a Client to interact with TGA. The System environment allows applicants to manage and lodge applications remotely, from an Internet-capable PC, electronically to the TGA through a secure transmission system using ssl2 data encryption technology. All application processing is performed on servers located at TGA. Information entered into Soltrade can only be viewed by your own organisation. Security Issues The security model is designed to create a single privileged-access control identity for each organisation (client) conducting electronic business with TGA. The security objective is to allow all users to:
• •
obtain access to only that information to which they are legally entitled; and
ensure all individuals with access to the system are identified and their authorisation established. Within the System, the security requirements are provided for and met through the SIME User Management application. Managing access to TGA ∈ Business TGA Role TGA will issue each Client a single organisational username/password login following a paper-based request. The account is to be known as the Client '∈ Business Administration Account' and can only be used to manage other username/ passwords within the organisation. TGA will create the organisation administration account and the person nominated as '∈ Business Administrator' in the User Management record will be automatically notified of their username/password by E-mail. The ∈ Business Administrator The ∈ Business Administrator will be solely responsible for the creation and management of other organisation logins that may be issued within the Client organisation. The ∈ Business Administrator will manage all the Client logins directly over the Internet through the User Management ∈ Business Administration Account – create users, delete users, and reset user passwords. When creating User accounts, the User Management application will allow a choice of two access roles to reflect the activities of the person within the Client organisation. The User Id
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may be assigned a 'drafter' of applications status or be given 'full submitter' access status, which will allow them to submit applications to TGA. The ∈ Business Administrator is responsible for ensuring that all owners of the User accounts created within the organisation are aware of the terms and conditions for use of the account, and that the organisation is responsible for any electronic transactions made by an account created by the ∈ Business Administrator. TGA ∈ Business Service Terms and Conditions Before you use the Internet Access service, you must have:
•
Submitted to TGA a copy of the ∈ Business registration form or have applied to use the Internet Access service in such other prescribed form as TGA may determine from time to time; Been approved as an Internet Access Service customer and have been issued an ∈ Business administration account with a password; and Read carefully and agreed to these conditions of use as they will form the contractual basis for the use of the Internet Access Service, between yourself and TGA.
• •
To register, please read the following terms and conditions. Any use of the Internet Access Service by you or a nominee is subject to these conditions of use: Upon accepting these terms and conditions: 1. You will be taken to have accepted these Service Terms and Conditions, when you or any additional user first uses the services of SIME. These Terms and Conditions 2. These electronic service terms and conditions are in addition to the terms and conditions agreed to as part of completing the Client Details form and to the extent of any inconsistency between the two, these terms and conditions will apply. Changes to the Service 3. TGA may: * Change the functionality or content of the service; or * Withdraw or deny access to the service at any time without prior notice Access to the Service 4. You agree TGA will give access to the service to anyone who uses a valid identification and password. Security of your password 5. You agree to keep your organisation passwords safe and secure. In particular you agree: *Not to tell any person your password or allow any person to observe as you enter the password. If you tell someone your password, they become your nominee and are subject to these conditions of use; * Not to write down or store your password. If you do so, you are responsible for keeping the record secure and protected. We advise you to keep any record of your User Id and password separate from each other.
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6.
You agree to change your password the first time you use the Internet Access Service and at frequent intervals thereafter. We strongly recommend that you do not use an obvious password such as a dictionary word, name, date or vehicle details or any other combination that is directly associated with yourself. You agree to immediately tell TGA if you suspect the security of a UserId or password has been compromised. TGA may cancel the use of your access for the service at any time without notice if we believe the access is being used, or will be used, in a way that will cause losses to you or us We will take such reasonable precautions as may be necessary to ensure that information concerning your accounts transmitted by us through the service will remain confidential and protected from unauthorised access but we will not otherwise be liable for any unauthorised access by any means to that information.
7.
8.
Account Information 9. The information about your administration account will be audited and changes monitored by TGA. Changes to user account details remain your responsibility. The information about your accounts will reflect the current status of the accounts on our systems at the time you access the system. Liability 10. You acknowledge that, subject to your rights implied at law which cannot be excluded, we will not be liable for any loss or damage in connection with any use of the service unless the loss or damage is directly attributable to our fraudulent or negligent conduct. Changes to these Terms and Conditions 11. TGA may change these terms and conditions at any time. We must notify you of any such changes. Termination 12. TGA may terminate the service at any time without notice to you. Interpretation 13. Account/User account means each or all of your accounts with TGA, which may be used to access the TGA Internet Service. 14. Service means the TGA's Internet Access service, which you access via the Internet. This facility allows you to obtain information on your ARTG entries, applications and to carry out transactions on your own applications. 15. We, us means TGA. 16. Sponsor means any person who is legally responsible for the entry on the ARTG and recorded on the Client system as a Sponsor. 17. Agent means any consultant, corporation or person that completes and submits TGA forms as a duly appointed agent of a Sponsor, but is not a member of the Sponsor organisation, and is recorded on the Client system as an Agent.
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