Guidelines for launching your drug product or a medical device in the Australian Market

1. PRESENTED BY-
BHAVIN. R. CHORADIYA.

4. 1. Confirm the regulatory status
• Is the product a therapeutic good? Confirm if the
goods that are intended for supply are therapeutic
goods by checking the definition of therapeutic goods
in the Therapeutic Goods Act 1989 (the Act) and the
information about ‘What are therapeutic goods?’ on
the TGA website.

5. • Is the product already authorised for supply in Australia?
• Search the ARTG for the product.
• If the product is not in the ARTG, or if you wish to import it directly
and be the first point of supply, you will need to get TGA approval.
• If it has already been entered in the ARTG, it has already been
approved by the TGA and been authorised for supply in Australia. If it
is in the ARTG, and you wish to become a retail seller you can contact
the sponsor directly, but be aware that there could be commercial
agreements in place that may not allow this.

6. 2. Determine the type of therapeutic good and
the relevant regulatory guidance
•Different application processes and regulatory
requirements apply depending on the type of
therapeutic good that is to be supplied. You are
advised to review the relevant guideline
document before making further enquiries to
the TGA.

7. • A prescription medicine is generally a medicine that
requires a prescription from a registered health care
practitioner, or contains a substance included in
Schedule 4 to 8 of the Poisons Standard. For more
information see Scheduling of medicines & poisons
and the Australian Regulatory Guidelines for
Prescription Medicines (ARGPM).

8. •An over-the-counter (OTC) medicine is generally
a medicine that can be purchased without a
prescription but from a pharmacy or in some
cases from the supermarket. For more
information see the Australian Regulatory
Guidelines for OTC Medicines (ARGOM).

9. •A complementary medicine is generally a herbal
or ‘traditional’ medicine, and includes vitamins
and homeopathic products. For more
information see the Australian Regulatory
Guidelines for Complementary Medicines
(ARGCM).

10. • A medical device includes a range of goods such as
bandages, pacemakers, x-ray equipment, and in vitro
diagnostic (IVD) medical devices. For more detail see
What is a medical device? Further information on
supplying a medical device is provided at What do I
need to do to supply a medical device in Australia?
and the Australian Regulatory Guidelines for Medical
Devices (ARGMD).

11. •A biological is generally a product of human
origin, such as bone grafts or stem cells. For
more information see Australian regulatory
framework for biologicals and Australian
Regulatory Guidelines for Biologicals
(ARGB).

12. • An other therapeutic good (OTG) includes things such
as disinfectants and tampons. For more information
see Other therapeutic goods, Device/medicine
boundary products, and the OTG information on the
TGA website.
• A combination product incorporates two or more of
the above product types. It is strongly recommended
to review Device-medicine boundary products
information on the TGA website.

13. 3. Make sure your product meets the legal
requirements
• There are legal requirements that apply to all therapeutic goods, such
as manufacturing requirements and product and labelling standards,
and there must be evidence to support the therapeutic claims made
about the goods. Your product will not be approved by the TGA and
authorised for supply unless all the relevant legal requirements are
met.
• Review the relevant regulatory guidelines to make sure that your
product will meet all necessary legal requirements.

14. Manufacturer requirements
• All Australian sites participating in the manufacture of the medicine
must have a licence to manufacture therapeutic goods issued by the TGA
that permits the manufacturing steps and dosage forms relevant to the
goods being supplied. For sites located overseas, the sponsor must
obtain a Good Manufacturing Practice (GMP) clearance for the site that
permits the manufacturing steps for the required dosage forms to be
undertaken.
• Medicines and biologicals (except class 1 biologicals) must be
manufactured in accordance with the principles of GMP. For medical
devices (except class 1 medical devices), a manufacturer must hold a
TGA conformity assessment certificate or equivalent certification issued
by a European Notified Body.

15. 4. Familiarise yourself with your legal
responsibilities
•As well as the legal requirements that must be
met before a product is approved, sponsors have
ongoing legal responsibilities once their product
is in the ARTG. Civil and criminal penalties may
apply where these requirements are not met.
For information about the penalties for
breaching the therapeutic goods legislation,
please refer to the Act.

16. 5. Fees and charges
• A summary of the current regulatory fees and charges,
including application, evaluation, and manufacturer
inspection fees, are available on the TGA website. These are
reviewed and updated at minimum on an annual basis.
• Be aware that there will likely be business setup costs
involved with ensuring your product can meet the regulatory
requirements before you apply to the TGA.

17. 6. Regulatory assistance
• The Regulatory affairs consultants area of the TGA
website provides information on industry
organisations who may be able to recommend
suitable consulting services.
• Please note: Sponsors and manufacturers should also
refer to the Act and Regulations to ensure currency
and completeness of information.

35. THANK YOU……