Department of Health

Department of Health and Aged Care

MoH website

https://www.health.gov.au/

Regulatory Authority

Therapeutic Goods Administration (TGA)

Link for Regulatory Authority

https://www.tga.gov.au/

Regulation

Therapeutic Goods Act 1989

Therapeutic Goods Regulations 1990

Legislation

Therapeutic Goods Act 1989
Therapeutic Goods Regulations 1990
Therapeutic Goods (Medical Devices) Regulations (if applicable)
Relevant TGA Orders

Website

https://www.tga.gov.au/about-tga/legislation

Local Authorized Representative Required

Yes

FSC Required

May be required depending on application type.

License Validity

Valid until cancelled, suspended, or voluntarily withdrawn, subject to annual ARTG charges and regulatory compliance.

Drug Classification

1. Registered medicines
2. Registered medicines (AUST R)
   Prescription medicines
   Higher-risk OTC medicines
   Some complementary medicines
3. Non-prescription medicines. (Low Risk)
4. Listed medicines (AUST L)
   Lower-risk complementary medicines
5. AUST L – Listed
6. AUST L(A) – Assessed Listed

Overview

Australia is one of the world's well-established and highly regulated pharmaceutical markets. Therapeutic Goods Administration (TGA) regulate medicines, medical devices and biologicals to help Australians stay healthy and safe. Manufacturers are required to get clearance from the TGA, which regulates medication registration and approval in Australia, before distributing or selling medicinal items or pharmaceuticals. 

For the registration and maintenance of goods, compliance, and drug approval procedure for medical products in Australia, the TGA has certain regulatory criteria. Manufacturers or sponsors must stay up to speed with the most recent TGA Regulatory regime owing to recent demands regarding labeling and submission forms.

TGA Regulation of Medicines

• All medications delivered within Australia are required to be registered in the Australian Therapeutic Goods Register (ARTG).
• Drugs will appear in the ARTG either Listed or Registered. The AUST L, AUST L(A), or AUST R number (which is the medication’s ARTG number) on the label indicates whether a medication is listed or registered.
• Before going on sale, registered medications are always assessed for effectiveness, or the ability to perform as promised. However, not every medication on the list had its efficacy assessed.
• Two categories of listed medications exist:

1.   ‘listed’ AUST L medications that have not had their effectiveness evaluated.
2.  Medications on the AUST L(A) “assessed listed,” whose efficacy in relation to health claims has been evaluated.

• A medication must be produced in a licensed or approved facility in compliance with the good manufacturing practice (GMP) guidelines, regardless of whether it is registered or listed in the ARTG.

Differences between listed, assessed listed and registered medicines

OTC New Medicines Registration Process

Over the counter (OTC) medicines are sold without a doctor’s prescription and have undergone a full TGA pre-market evaluation of their safety, quality, and efficacy before being supplied in the marketplace. OTC medicines are mostly like prescription medicines as they contain higher-risk ingredients and make higher-risk indications than certified/ registered complementary medicines.

Registration Phases

Step 1 – Verifying your OTC medicine and access to Business Services

• For the verification of an OTC medicine that requires registration on the ARTG, refer guidance:  Pathway to evaluating your medicine
• Applications are created and lodged through the  Business services . A client ID number and password will be required to access the business services.
• Proceed to Step 2 in case a previous determination has been made that the medication is an over the counter (OTC) product requiring registration on the ARTG, and possession of a client ID number and password for accessing TGA Business services.

Step 2 – Checking for new medicine ingredients:

Before applying for OTC medicine, an assessment should be done for new ingredients. The ingredient should be checked from:

• Ingredients Table
• Proprietary Ingredients Table

Step 3 – Determining Application Level:

Applications to register an OTC medicine are categorized into five levels, based on risk and have different fees and  target evaluation times.

1. N3 Generic medicines that are not an N1, N2 or N4 level application (N3 applications require CTD Modules 1 and 3).
2. N4 Generic medicines that require supporting safety and/or efficacy data / have not been previously registered as an OTC medicine following down/ scheduling require a higher-level assessment due to the umbrella segment of the product name.
3. N5 New medicines that are not generic, including either one or more new: active ingredient (new chemical entity), combination of active ingredients, indication, strength, dosage form, directions for use for patient population.

Step 4 – Checking guidelines and mandatory requirements

All the relevant guidelines for specific requirements should be checked

1. OTC -specific guidelines
2. European Union and ICH guidelines adopted in Australia

The following mandatory requirement should be followed for an effective and successful application.

1. Mandatory requirements for an effective OTC medicine application
2. CTD Module 1: OTC medicines   Take note of the obligation stated in CTD Module 1.5.8, which necessitates the submission of an umbrella brand assessment for applications requiring a more extensive evaluation because of the umbrella segment in the product name.
3. Common Technical Documentation (CTD)
4. General dossier requirements
5. Cover letter

Step 5 – Ensuring valid GMP evidence

• Valid evidence that the manufacturers of your OTC registrable medicines have been certified to perform each step in the manufacture of the goods is necessary.
• Failure to provide valid evidence of GMP will result in failure to validate the application upon submission.
• The application cannot be concluded unless there is up-to-date and valid GMP clearance (issued by the TGA) for every foreign manufacturer. It is imperative to guarantee that the GMP clearance remains valid throughout the evaluation period.
• Ensure that the GMP clearance remains valid for at least the specified minimum duration following the submission of application.

 3 months: N1 applications

4 months: N2 applications

6 months: N3, N4, and N5 applications.

Step 6 – Compiling data for application

1. A dossier of administrative and technical documentation for OTC medicine must be submitted in electronic format for evaluation.

2. Compile an electronic dossier in accordance with the Common Technical Documentation (CTD). Make certain that the application dossier comprises all necessary administrative and technical data essential for the application level.

3. Verify that the dossier is complete, follows the specified format, and incorporates the necessary details for a comprehensive application outlined in CTD Module 1 for OTC medicines.

4. This should cover the mandatory requirements for an effective OTC medicine application and adhere to the guidance provided for composing your cover letter.

Step 7 – Completing and submitting your application

To complete and submit your application, following steps to be followed:

1. Log in to  Business services.
2. Select ‘Applications’.
3. Select the appropriate application form under Over-the-Counter Medicine.
4. Complete the application form.
5. Attach the application dossier (compiled in Step 6) to the application form or submit the dossier on CD/DVD/USB.
6. Select ‘Submit’ and agree to the declaration and relevant assurances.

   A submission number will be issued which uniquely identifies the application.

Step 8 – Paying fees

TGA charges an application fee and an evaluation fee based on the level of the application.

Applicant can apply for concurrent (reduced) costs, if there are multiple applications submitted at the same time, provided all the applications have:

• same sponsor;
• same application level.
• the same active components.
• enough similar supporting data to allow for simultaneous review.

Step 9 – Screening of application

1. Screening of OTC medicine applications will be done to verify if it has been submitted at the correct application level and meets the effective requirements.

2. Application is effective if it meets the requirements mentioned under section 23(2) of the Therapeutic Goods Act 1989.

Step 10 – Evaluating and requesting information

During evaluation of OTC medicine application, TGA will:

–        assess the data and information,

–        review your responses to our requests for information and document the findings.

Step 11 – Making the OTC registration decision

The delegate of the Secretary of the Department of Health will:

1. Review all documentation associated with the application, including:

2. The application and submission dossier

3. The evaluation reports

4. Responses to requests for information

5. Advice from expert advisory committees

6. Other relevant advice or information

7. Consider the detailed matter under section 25 of the Act, including whether the medicine’s effectiveness, safety, and quality have been demonstrated.

8. Once the decision is made, TGA will send out a written notification of the decision.

Step 12 – Finalizing your OTC registration

1. This stage involves finalizing the registration once a decision has been made on whether to register an OTC medicine.

2. TGA provides the decision letter if it is decided to register the medication.

3. The decisions taken by the Secretary’s delegate to impose general and requirements on the registration of your medication in the register in accordance with Section 28 of the Therapeutic Goods Act 1989 are included in this letter.