Depending on what you intend to produce as a manufacturer, you may need specialist licences or certificates. To avoid legal issues going forward, it is crucial to understand what sort of licence you might need to manufacture your products. This article will unpack licensing and permit requirements for your business in the manufacturing sector.
Licensing to Manufacture Therapeutic Products
In Australia, it is illegal to manufacture therapeutic goods without a licence. You must apply to the Therapeutic Goods Association for a manufacturer’s licence as an Australian manufacturer. Therapeutic goods include:
- medicine;
- medical devices, such as pacemakers;
- biologicals, blood tissues and advanced therapies; and
- medical cannabis products.
Your business must comply with several requirements to maintain a manufacturing licence for therapeutic goods. In particular, you must:
- comply with any product quality requirements set out by the Therapeutic Goods Association;
- meet the Good Manufacturing Practice requirements, which state that quality must be built into every stage of the manufacturing process;
- keep records of materials used, procedures used in the manufacturing process, details of tests performed on the manufactured products and other relevant information;
- pass any inspections by the Therapeutic Goods Association on your premises.
Industrial Chemicals
If you manufacture industrial chemicals in Australia, you must register your business with the Australian Industrial Chemicals Introduction Scheme. Registration requires an Australian Business Number (ABN), and you must pay fees and charges depending on what you manufacture. You will also need to submit an annual declaration to the Scheme, listing which chemicals you have manufactured each year.
Continue reading this article below the formPesticides and Veterinary Medicines
To manufacture pesticides or veterinary medicines, you must obtain a licence from the Australian Pesticides and Veterinary Medicines Authority. You will also need a licence if you are involved in any step of the manufacturing process. As with the manufacture of therapeutic goods, you must comply with Good Manufacturing Practices.
Electrical Equipment
If you manufacture electrical equipment in Australia, you will need to meet the Electrical Equipment Safety System requirements. These requirements include:
- ensuring the electrical equipment is electrically safe and is categorised as risk level 1, 2 or 3;
- meeting the Electrical Equipment Safety System’s safety requirements;
- registering with the Electrical Equipment Safety System; and
- marking your products with the Regulatory Compliance Mark.
Excisable Products
You will need a licence to manufacture exciseable products, which are those whose import requires a tariff to be paid. These products include alcohol, tobacco, and energy products.
To qualify for a licence, the Australian Taxation Office (ATO) must deem you a fit and proper person. This might include a background check and a criminal record check, among other things. It will also include checks on your business partners, directors, employees, and the company. The ATO will also look into the following:
- whether or not you have experience in your area of manufacture that would make you a suitable manufacturer of the excisable product;
- whether you have suitable manufacturing premises; and
- if you can adequately audit and account for your business.
The Australian Government is changing the law to protect consumer privacy after a series of high-profile data breaches and to bring the law into line with the safer and more protective laws in other regions. This fact sheet outlines what is expected in 2024.
Key Takeaways
Understanding your licensing requirements as a business in the manufacturing sector is critical to staying legally compliant. You may need to apply for specific licences to produce particular goods as a manufacturer or import them. Notably, you will need a specific licence if you:
- produce therapeutic goods, such as medicine or medical equipment;
- produce industrial chemicals;
- produce pesticides or veterinary medicines;
- manufacture electrical equipment; or
- manufacture exciseable products, including alcohol or cigarettes.
If you need help applying for the relevant licence or understanding which licensing regime you might fall under, our experienced manufacturing lawyers can assist as part of our LegalVision membership. For a low monthly fee, you will have unlimited access to lawyers to answer your questions and draft and review your documents. Call us today on 1300 544 755 or visit our membership page.
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