The process of registering over-the-counter (OTC) medicines in Australia is regulated by the Therapeutic Goods Administration (TGA). The exact process depends on the type of product and the regulatory pathway, but typically involves the submission of detailed documentation and scientific data to support the safety, quality and efficacy of the product.
What are OTC (over-the-counter) medicines in Australia?
OTC (over-the-counter) medications are widely accessible. We can purchase them without a prescription from many locations, including supermarkets, health-food stores, or online, in addition to the typical pharmacy.
- Few examples include simple analgesics, cough and cold remedies, and anti-fungal therapies, is a crucial part of primary healthcare.
- They are safe and effective when used according to the directions on the label and those provided by your healthcare practitioner.
OTC medicines market in Australia
The market for over-the-counter (OTC) products in Australia is significant and growing. The Australian OTC market is valued at over AUD 2 billion and includes a wide range of products, such as pain relief medications, vitamins and supplements, cough and cold remedies, dermatological products, and digestive health products.
The market is driven by an aging population, increasing health awareness, and a growing preference for self-care. The industry is highly competitive, with both international and local companies vying for market share.
Regulatory for OTC medicines in Australia
The Therapeutic Goods Administration (TGA) of Australia registers, certifies and tests OTC medications that have undergone quality, safety, and efficacy testing.
You must register any medical products you plan to export, supply, or import from Australia with the Australian Register of Therapeutic Goods (ARTG).
How the TGA regulates OTC (over-the-counter) medicines?
- OTC drug registration has five application levels: N1, N2, N3, N4, and N5.
- The selection of an application level depends on a variety of factors.
- These medications typically carry an intermediate level of risk and have therapeutic claims for the treatment or prevention of disease.
- Stability data estimate the shelf life of these medications, although, in the event of an N2 application, the finished product shelf life, warning, and usage instructions should be consistent with the OTC monograph. This group of medications may include antiseptic lotions, cough and cold remedies, and painkillers.
- An application must be submitted to the TGA by a sponsoring company for a medicine to be listed in the Australian Register of Therapeutic Goods.
- The TGA developed the Australian Regulatory Guidelines for OTC Medicines (ARGOM) to aid OTC medicine sponsors in adhering to regulations.
- Depending on the degree of risk connected to making the product accessible to consumers, OTC medications may be registered or listed on the Australian Register of Therapeutic Goods.
Overview of OTC medicines registration in Australia
Depending on the level of risk, there are five categories for applications to register an OTC drug:
- Applications to register over-the-counter medications that have well-known active components or are exact replicas of already-registered OTC medications fall under the lower-risk category.
- More intricate uses, such as drugs with novel active components or new indications, carry higher risk levels.
The OTC application levels have established submission deadlines and specifications. For applications with lesser levels of risk, fewer supporting documents are necessary, and shorter target times apply.
You have to fill out the application electronically. You have to use it in Technical Document (CTD) format.
Following receipt of an application for the registration of an OTC drug, they review it to see if it is comprehensive and complies with the standards. The application is approved for evaluation if it is successful.
They might ask the applicant for information during the evaluation process to remedy problems that they have found.
The secretary’s representative ultimately decides whether to include the medication in the Australian Register of Therapeutic Goods (ARTG) following evaluation.
New OTC medicine registration process in ARTG
Applicants who want to register an over-the-counter (OTC) medication with the Australian Register of Therapeutic Goods (ARTG) should follow the following steps.
1. Determine regulatory pathway
The first step is to determine the appropriate regulatory pathway based on the type of product and its intended use. There are different pathways for different types of products, such as cosmetics, complementary medicines, and prescription medicines.
2. Choosing the appropriate application level
You have to choose the appropriate application level.
If your application doesn’t have the required information for the application level, it won’t be accepted for evaluation under Section 23(2)(b) of the Therapeutic Goods Act 1989- external site).
OTC Medicine Application Classification
|Application Level||Medicine Type||Risk Level||Applicable Data Requirement||Attributes||Total TGA Evaluation Time|
|N1||Generic||Negligible||CTD M1||Clones or flavor/fragrance/color variants of a currently registered medicine||45|
|N2||Generic||Negligible||CTD M1CTD M3||In line with OTC monograph||55|
|N3||Generic||Low||CTD M1CTD M2CTD M3||Not an N1, N2 or N4 application||150|
|N4||Generic||Low||CTD M1CTD M2CTD M3CTD M4CTD M5||Active not previously registered||170|
|N5||Non-Generic||Moderate||CTD M1CTD M2CTD M3CTD M4CTD M5||New chemical entity or combination of active ingredients or new indication or strength or dosage forms or direction for use or patient population||210|
Common Technical Document (CTD), Regional administrative information module (M1), Quality, nonclinical and clinical summaries and overview module (M2), Quality module (M3), Nonclinical study reports (M4), Clinical study reports (M5), New Medicines (N).
3. Prepare documentation
The next step is to prepare a detailed submission, which includes a product information file, labelling, and a product complaint handling procedure, as well as any required supporting documentation, such as scientific data to support the safety, quality, and efficacy of the product.
4. Submit application
The completed submission is then submitted to the TGA for evaluation.
The TGA will evaluate the submission and may request additional information or clarification. The evaluation process can take several months, depending on the complexity of the product and the amount of information provided.
6. Pay the fees
The fee for registering over-the-counter (OTC) products in Australia is set by the Therapeutic Goods Administration (TGA). It varies based on the type of product, the regulatory pathway and the time required for evaluation. There is no standard fee and the exact amount can only be determined on a case-by-case basis.
Approval: If the product is approved, the TGA will issue a certificate of registration and the product will be listed on the Australian Register of Therapeutic Goods (ARTG).
Once the product is listed on the ARTG, it can be marketed and sold in Australia. The marketing of the product must comply with the relevant legislation and regulations, including advertising and labeling requirements.
Necessary forms in the registration process
- Notification of new proprietary ingredient
- Amendment of advisory statements for medicine labels(RASML)
- Notification of transfer of sponsorship
The process to change a registered OTC medicine
This advice is for sponsors who want to update an over-the-counter (OTC) non-prescription medication listing in the ARTG.
First, you have to locate the regulatory procedure you must follow.
Then they guide you through it step by step and provide links to pertinent instructions and forms.
The steps of the process
- Verification of your change requires prior TGA authorization.
- Identifying the level of your application and the change codes
- Getting a unique identification number for new proprietary compounds
- If the medication does not contain a novel proprietary flavor, scent, ink, or color, omit this step.
- Ensuring the validity of GMP evidence
- Gathering information for your application
- Changing multiple medications (If you only wish to switch one medication, skip this step)
- Application completion and submission
- Paying the fees. (add below para)
- Examination of your application
- Assessing and making inquiries
- Completing the application
The sponsor may submit additional applications to change the registration requirements after a product is registered. They need the following details,
- Altered labels
- The shelf life varies
- Formulation alterations
- Changes in quality control
- Modified indications
- Changes to the usage instructions
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