Guidance for new registered complementary medicine applications How to submit your application

Guidance for new registered
complementary medicine
applications
How to submit your application
Version 1.0, April 2014
Therapeutic Goods Administration
About the Therapeutic Goods Administration (TGA)
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The Therapeutic Goods Administration (TGA) is part of the Australian Government
Department of Health, and is responsible for regulating medicines and medical devices.
The TGA administers the Therapeutic Goods Act 1989 (the Act), applying a risk management
approach designed to ensure therapeutic goods supplied in Australia meet acceptable
standards of quality, safety and efficacy (performance), when necessary.
The work of the TGA is based on applying scientific and clinical expertise to decisionmaking, to ensure that the benefits to consumers outweigh any risks associated with the use
of medicines and medical devices.
The TGA relies on the public, healthcare professionals and industry to report problems with
medicines or medical devices. TGA investigates reports received by it to determine any
necessary regulatory action.
To report a problem with a medicine or medical device, please see the information on the
TGA website <http://www.tga.gov.au>.
Copyright
© Commonwealth of Australia 2014
This work is copyright. You may reproduce the whole or part of this work in unaltered form for your own personal use or, if
you are part of an organisation, for internal use within your organisation, but only if you or your organisation do not use the
reproduction for any commercial purpose and retain this copyright notice and all disclaimer notices as part of that
reproduction. Apart from rights to use as permitted by the Copyright Act 1968 or allowed by this copyright notice, all other
rights are reserved and you are not allowed to reproduce the whole or any part of this work in any way (electronic or
otherwise) without first being given specific written permission from the Commonwealth to do so. Requests and inquiries
concerning reproduction and rights are to be sent to the TGA Copyright Officer, Therapeutic Goods Administration, PO Box
100, Woden ACT 2606 or emailed to <[email protected]>.
Guidance for new registered complementary medicine applications
How to submit an application
V1.0 April 2014
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Therapeutic Goods Administration
Version history
Version
Description of change
Author
Effective date
V1.0
Original publication
Office of Complementary
Medicine
9 April 2014
Guidance for new registered complementary medicine applications
How to submit an application
V1.0 April 2014
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Therapeutic Goods Administration
Contents
How to submit an application for a new registered
complementary medicine ________________________ 5
Introduction ______________________________________________________________________ 5
Steps for lodging an electronic application for a new registered
complementary medicine ______________________________________________________ 5
Step 1: Obtain access to eBS and the online application portal -------------------5
Step 2: Notify the TGA of your pending application ----------------------------------6
Step 3: Commence application --------------------------------------------------------------6
Step 4: Populate information tabs ---------------------------------------------------------6
Step 5: Save, validate and submit application ------------------------------------------8
Step 6: Invoice raised --------------------------------------------------------------------------8
What happens next? _____________________________________________________________ 9
Guidance for new registered complementary medicine applications
How to submit an application
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Therapeutic Goods Administration
How to submit an application for a new registered
complementary medicine
Introduction
This document is provided for applicants of new registered complementary medicines and
explains the process for electronic submission of your application using the new TGA eBusiness
Over The Counter medicine portal (eBS OTC portal) (April 2014).
An electronic application form for a new registered complementary medicine can only be
submitted via the new Portal for Over the Counter (OTC) medicines in the TGA’s eBusiness
Services (eBS).
The portal has been designed to support the new OTC business process, and thus is
fundamentally different to the previous eBS OTC portal. Importantly however, the new eBs OTC
portal retains the ability to receive applications for registered complementary medicines, and
this guidance document explains how you can use the new portal to make such applications.
Note: The use of the eBS OTC portal for registered complementary medicines
applications is principally for the administrative purpose of submitting an
application form. However, if desired, applicants may also submit their
respective application dossier electronically via the eBS OTC portal.
All complementary medicine applicants should refer to Australian Regulatory
Guidelines Part D: Registered complementary medicines for information on the
evaluation process for registered complementary medicines
Currently, only applications for new registered complementary medicines that would result in a
new AUST R number are accepted via the eBS OTC portal. For other application types (for
example: ‘variation’ requests or applications for new complementary medicine that meet the
criteria for 'grouping' with a medicine already registered) refer to Forms for complementary
medicine sponsors for the relevant application forms.
If you require specific help with the eBS OTC portal when submitting your registered
complementary medicine application, please contact the Office of Complementary Medicines
(OCM).
Steps for lodging an electronic application for a new
registered complementary medicine
Step 1: Obtain access to eBS and the online application portal
To access the eBS OTC portal you will require a user name and password. If you already have a
valid eBs client ID, this will operate with the new eBS OTC portal.
If you do not have an eBS client ID, you must first submit a Client details form to obtain a 'client
identification number'. Having obtained a client identification number, you can submit an eBS
Access Request Form to become the 'E-Business Administrator' for your company and then can
apply for user accounts for yourself and other personnel in your company.
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How to submit an application
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Therapeutic Goods Administration
For further information about obtaining a client identification number or gaining access to eBS,
contact the TGA by phone 1800 010 624 or email [email protected].
Step 2: Notify the TGA of your pending application
At least two business days before making an electronic application, you should notify the OCM
by letter or email (see Office of Complementary Medicines for contact details) of your intention
to lodge the application.
You do not need to submit any paper documentation at this stage.
Step 3: Commence application
To begin an electronic application:
a.
Login to the eBS portal
b.
Navigate to ‘Over The Counter Medicine’ and click on ‘Non-prescription medicine’.
At this stage you may be presented with a ‘Welcome to the Over-The-Counter (OTC) medicines
online application system’ screen. Note this information is not relevant to registered
complementary medicine applications.
Step 4: Populate information tabs
The application form has several tabs at the top of the page. You are required to navigate
through each tab and provide the required information. Each tab contains fields which are
mandatory, as denoted by a red asterisk or marked ‘mandatory’.
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Therapeutic Goods Administration
a.
The first information tab is labelled ‘Application’. Click on ‘Select application type’ and select
N5 from the drop down box.
b.
Proceed through each of the tabs and populate required fields.
Within the N5 category, fill out the required information for all tabs.
c.
When completing the ‘Supporting Information’ tab, check all data components that you will
be supplying to the TGA, either attached to the electronic application form or sending by an
alternative method. While you are encouraged to submit your supporting information
(application dossier) electronically, electronic submission is not a mandatory requirement.
Note that the provision of your data in the Common Technical Document (CTD)
format or the recommended folder names is not a mandatory requirement for
a new registered complementary medicine application. However, presentation
in this manner is encouraged and will expedite evaluation.
Refer to the Australian Regulatory Guidelines Part D: Registered
complementary medicines for guidance on the information required to support
a new complementary medicine registration application and how to present
this to the TGA.
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You may attach your supporting documentation to the electronic application
form. Alternatively, this can provided to the TGA electronically via email,
electronic media (CD, DVD or USB) or as a hard copy.
If you choose to submit a hard copy application dossier, please send your
application, covering letter and supporting data dossier to either of the
following:
Postal address
The Director
Premarket Assessment Section
Office of Complementary Medicines
Therapeutic Goods Administration
PO Box 100
Woden ACT 2606
Address for courier delivery
The Director
Premarket Assessment Section
Office of Complementary Medicines
Therapeutic Goods Administration
136 Narrabundah Lane
Symonston ACT 2609
Step 5: Save, validate and submit application
a.
At any time during the application process you may save your application. The draft
application will remain available for editing at a later date.
c.
If validation of your application fails then you be will receive ‘Failure Messages’ advising
what aspects of your application form need to be corrected.
b.
d.
Once you have completed all mandatory aspects of the application form a validation is
required. This is done by clicking the validation button.
Once your application validates, submit the application by clicking the submit button.
Step 6: Invoice raised
Once you have submitted your application, an invoice will be raised comprised of an application
fee (non-refundable) and a pre-determined base evaluation fee (refer to Summary of fees and
charges at 1 July 2013). For options on how to make your payment refer to Payment options on
the TGA website.
The total evaluation fee applicable to your application will be determined by the TGA. In some
cases this may exceed the base evaluation fee initially invoiced, for example: if your application
dossier consists of clinical and toxicological data that exceeds the base evaluation fee page count
(that is, 51 pages or more) then you will be invoiced for an additional supplementary fee once a
pre-evaluation assessment has been performed by the TGA.
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How to submit an application
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Therapeutic Goods Administration
In certain circumstances you may have adequate justification to request a reduction of your
evaluation fee under Regulation 45 of the Therapeutic Goods Regulations 1990. If so, attach this
request to your eBs application (or include your request in your covering letter if providing your
application in hard copy). After the request is assessed, the base evaluation fee may be adjusted
accordingly and a refund may be provided.
Your application will not proceed until both the application fee and base evaluation fees have
been paid.
What happens next?
A pre-evaluation assessment of your application dossier will be undertaken by the TGA to
determine if the dossier is acceptable for evaluation and that the evaluation fee paid is
appropriate.
The evaluation process will commence as soon as the submitted information is considered
satisfactory as determined by the pre-evaluation assessment and the evaluation fee has been
paid in full.
You will be notified in writing by the OCM regarding the acceptance or otherwise of the
application for evaluation.
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How to submit an application
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Therapeutic Goods Administration
PO Box 100 Woden ACT 2606 Australia
Email: [email protected] Phone: 1800 020 653 Fax: 02 6232 8605
http://www.tga.gov.au