At Archer Emery & Associates we provide a range of other services related to the therapeutic products.
Many people have a product that they would like to supply in Australia, but they are not sure where to begin. The boundaries between medicines, cosmetics and food can be very blurry! Some devices may be medical devices and other very similar ones are only aesthetic products which do not have a therapeutic use. Antimicrobial products can be in any one of 5 regulatory categories! It might all depend on the wording of the claims on the labels, accompanying documentation and in advertising. Even whether a therapeutic product is a medicine of a medical device can be the subject of debate! At Archer Emery & Associates, we can help!
We have many years’ experience in all the major therapeutic categories and with assessing borderline products. We can assist you by:
Scheduling of substances is a means of legally controlling both access to them and advertising them. It is done via the States’ and Territories’ enabling legislation that incorporates the Poisons Standard (previously known as the Standard for Uniform Scheduling of Medicines and Poisons (SUSMP)).
The Advisory Committee on Medicines Scheduling (ACMS) makes recommendations on the classification of ingredients used in medicines. The Advisory Committee on Chemicals Scheduling (ACCS) makes recommendations on the classification of other substances. Both were previously combined as the National Drugs and Poisons Schedule Committee (NDPSC).
The recommendations of these committees affect medicines, devices, cosmetics and chemical products; how they are packaged, where they can be sold and what information needs to be on labels.
The process of rescheduling is asking for a substance to be moved from one schedule to another (usually lower) schedule to broaden its accessibility and/or to enable them to be advertised to the public. Often the rescheduling can be limited by the strength of the substance, by pack size, or by other parameters that ensure its safe use in the context of being more broadly available.
It is a complex and demanding application process. You need to know about the relationship between State and Commonwealth laws and how the Advisory Committee on Medicines Scheduling operates. Most importantly, you need to present clear and detailed arguments using the criteria set by the committee.
At Archer Emery & Associates, we can help you by:
The Advisory Committee on Medicines Scheduling makes changes to the classification of ingredients on a regular basis. The changes made by the Advisory Committee on Chemicals Scheduling (ACCS) can also affect your products. While these changes are announced in advance they are easy to miss and you may find your product has suddenly become more restricted.
At Archer Emery & Associates, we can help you by:
There are requirements around exporting therapeutic products from Australia that need to be met. This applies regardless of whether the goods are sold in Australia or not, although whether they are included in the ARTG for Australian supply does make a difference to what is required. You may need:
At Archer Emery & Associates, we can help you by:
We can also assist with the document authentication process required by some countries from DFAT and/or their embassies and other relevant bodies.
Over time, aspects of your products will change and evolve. This might be for product improvement, because a new piece of manufacturing equipment, or because your suppliers cannot no longer provide a particular ingredient/component, just to name a few.
At Archer Emery & Associates we can help by:
No matter how good your quality and safety systems are, problems can still occur that are out of your control or too late to avoid. It could be contamination, or the wrong amount of an active ingredient in a product.
Despite the best efforts of all concerned, sometimes things go wrong. You may then have an adverse event or a situation that might require a recall (or a non-recall action) .
Whatever it is, you need to have a plan to protect your consumers – and your market share. Because you will be judged on how quickly and effectively you deal with the situation.
Our experience in manufacturing and GMP, risk assessment and quality assurance means we can help you get the response right.
We can work with you to define the problem, conduct an urgent risk assessment to determine any impact on the consumer, and consider whether a recall is needed – and how far-reaching it should be.
At Archer Emery & Associates, we can help you by:
The sponsorship (legal ownership in Australia or New Zealand) of therapeutic products often changes from one entity to another. When this happens, the TGA/Medsafe needs to be informed. This is done by submitting a transfer application. Usually this is a straightforward process, however it still needs to be done correctly and at the appropriate time.
At Archer Emery & Associates, we can help you by:
TGA imposes annual charges on all entries that are included in Australian Register of Therapeutic Goods (ARTG) on 30 June each year. The charges are payable on the following 1 October each year, and failure to pay will mean that the TGA cancels the entries.
However, if you have a product included in the ARTG for which there has never been turnover, you are likely to be entitled to an exemption under the Annual Charge Exemption (ACE) scheme. You can only make an application for exemption for a limited time between 1 July and 22 July each year. If you miss this window, it is possible to reinstate the exemption before 15 September, although a late fee is payable.
Once the TGA has imposed an annual charge the ARTG entry is no longer eligible for the ACE scheme at any point in the future, regardless of whether there has ever been turnover in relation to the entry or not.
At Archer Emery & Associates, we can help you by:
Transferring ARTG entries from one sponsor to another is usually a relatively straightforward process in itself, but there can be some traps for the unwary.
At Archer Emery & Associates, we can assist by:
If you are planning to purchase the sponsorship of products in the ARTG (or a company that is the holder of that sponsorship) you need to be aware of any problems that you may be buying aspart of this process.
At Archer Emery & Associates we can help by working with your legal team to:
Archer Emery and Associates – the Therapeutic Goods Administration (TGA) Experts. To find out how to enhance your regulatory team and maximize your chances of success – whatever the project. Click here to get in touch >>
Talk to the regulatory experts
Postal Address:
PO BOX 638 Duncraig
WA 6023
Please enter you email below to stay up to date on the latest new and issues from theTherapeutic Goods Administration (TGA).
