PRESENTED BY-BHAVIN. R. CHORADIYA.

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.

• 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.

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.

•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).

•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).

•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).

•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).

•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).

•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.

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.

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.

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.

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.

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.

THANK YOU……