Sue Akeroyd & Associates
The Over-the-Counter (OTC) medicine market is one of the most dynamic parts of the healthcare market. They are medicines that do not need a prescription. Some can be bought at supermarkets but others at pharmacies only.
In recent years there has been a growing trend for consumers to self medicate. This has led to more consumers buying OTC drugs. As a result it has created new opportunities for businesses.
However, the Australian OTC is one of the most tightly regulated markets in the world. This can make it difficult to take advantage of these opportunities, without the proper regulatory advice.
Sue Akeroyd & Associates have had extensive experience in the OTC registration process to help you navigate the ‘red tape’.
The popularity of complementary medicines has grown significantly in recent years. In fact, it is now estimated around 60% of Australian consumers use complementary medicines.
The range of complementary medicines include vitamins, minerals as well as herbal and traditional medicines. They can be purchased from health food shops, supermarkets and pharmacies.
There are different types of complementary medicines – Listed complementary medicines, Listed-assessed complementary medicines and Registered complementary medicines. Most come are Listed. Each category has separate regulatory requirements.
Sue Akeroyd & Associates have had extensive experience advising local and global organisations in the complementary medicine market.
Medical devices cover a broad range of apparatus and applications, from diagnosis and monitoring of conditions through to control of conception. The range of apparatus includes medical gloves, facemasks, bandages, x-ray machines and blood pressure monitors.
To be able to sell a medical device in Australia it must be on the Australian Register for Therapeutic Goods (ARTG). A medical device will be classed on the Register based on the risk of harm it may pose for users. The TGA use a risk-based approach to regulating medical devices. This means the level of regulation is at the same level as potential risks posed by the medical device.
Sue Akeroyd & Associates can assist with determining the likely classification of the medical device, as well as the registration of the device with TGA.
Regulatory Consultants You Can Rely On
This is a complexly regulated industry, variously being controlled, and globally harmonised. Ingredients in cosmetic products are classed as industrial chemicals.
This is even the case when ingredients might be described as natural origin. As such, knowing their status in the national chemical substance inventory is critical.
This high level of regulation is all done to ensure products are safe for the workers handling them, the environment and for consumers to use.
Sue Akeroyd & Associates is well versed in the requirements of the Australian Government Department of Health’s Australian Industrial Chemicals Introduction Scheme (AICIS). Because of this we can help you avoid the pitfalls associated with this relatively complex legislative area.
The Australian Prescription medicine market is highly regulated. It has been described as one of the most policy sensitive sectors in the Australian industry. That’s why it is essential that applications follow the appropriate protocol.
Part of the application process is negotiating with relevant Government departments. This is a complex, costly and time-consuming process. It is the reason why you need someone with experience who is able to advise and guide you through the multi faceted process.
People who know and understand the legal and commercial framework, and who have access to decision-makers ensure that the maximum cooperation is available during the application process. This means applications are processed efficiently and ensures they are not delayed or rejected because important (but often obscure) protocols are not observed.
Sue Akeroyd & Associates provide a range of services for prescription medicine applications – for both pre and post-launch of products.
Foods and Food Supplements
Bi-national standards of Australia and New Zealand cover the whole of the food supply chain, from the farm to the table, for both the food manufacturing industry and primary producers. But, food supplements are affected by the food-therapeutic interface and may be considered medicine in Australia.
As a result, it can be a complicated process to determine your regulatory obligations. If the product is classified as medicine it will be regulated by the TGA and must be manufactured according to medicine good manufacturing practice standards with each ingredient needing pre-screening for eligibility.
However, if the product is classified as food, relevant standards cover the composition, labelling and contaminants, including microbiological limits. This is for both foods produced or imported for sale in Australia and New Zealand. In addition, the standards are enforced by agencies that vary for each state and territory.
Sue Akeroyd & Associates has the experience and expertise to handle your food standard regulatory requirements.
Product Concept Evaluation
We have years of experience across many therapeutic areas including medicines, foods, and cosmetics. With this knowledge we can evaluate your product concept before you invest time and money in the regulatory process.
Developing a product and then going through the regulatory process can be costly as well as a time intensive experience. That’s why it’s important to get a fresh perspective from a regulatory expert, who can provide the advice on the merits of your product.
Sue Akeroyd & Associates can help assess or modify the potential for product concepts.
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