We’ve identified a significant number of brands that have products yet to be updated to Permitted Indications on the Australian Register of Therapeutic Goods, the ARTG. With changes to the regulations, all these products will soon be immediately AUTOMATICALLY CANCELLED by the Therapeutic Goods Administration, the TGA.
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To clarify, on 6 March 2021 the TGA will AUTOMATICALLY CANCEL listings of all products on the ARTG that do not include Permitted Indications. After that, it will be illegal to sell any listed products that do not comply with the new regulations.
Find out more: Permitted indications for listed medicines (TGA website)
If you believe your products make a difference to the lives of the people that use them, that your products are doing something good in the world, then you need to TAKE ACTION NOW to ensure they don’t get cancelled once the new TGA Permitted Indications deadline arrives.
Can you afford to have any of your products cancelled?
After talking to multiple brands, it’s clear that the financial impact for a business is in excess of $80k per cancelled product.
So if you have a product without Permitted Indications that then automatically gets cancelled by the TGA next March, it could cost you upwards of $80k per cancelled product.
It’s a big hit (and not the good kind).
This cost estimation takes into account:
- Sales and profit
- Shelf space
- Out of stocks
- Orders in the system
- Loss of traction in the marketplace (and open the door for competitors to take your customers)
- Out of date marketing material
- Product flyers
- Brand website content
- External website content (distributor/chemists/etc)
- Illegal stock in the warehouse that will need to be WRITTEN OFF
Getting this wrong could be a massively time consuming and expensive exercise.
What do I need to know?
There are actually TWO deadlines that you need to know about. Each one affects the other.
TGA Deadline #1: TGO 92 Labelling Order, 1 September 2020
The first is the TGO 92 Labelling Order, where after 1 September 2020 all products released for supply MUST ensure that their labels only include claims that are included on the product’s ARTG listing
The important part here is that a sponsor of a listed medicine must not, by any means, advertise a medicine for an indication other than those indications which are included on the ARTG for that medicine
The TGA state:
Medicines that are released for supply on or after 1 September 2020 (the end of the transition period) must comply with either TGO 91 or TGO 92, whichever is relevant.www.tga.gov.au/medicine-labels-guidance-tgo-91-and-tgo-92
Let’s take a look at an example, and there are many examples just like this one. If you have indications on your label or marketing material that talk about your product supporting DNA synthesis or nerve myelination, these will only be valid in the short term and NOT once you update your listing to the new Permitted Indications regulations. Why? Because these are no longer acceptable claims as per the permissible indications determination.
Once you update to Permitted Indications, if you’re still selling the product and promoting its use based on your old listing, your product has an increased risk of cancellation. If you received a Section 31 or Section 30 Notification to Cancel, your product would be non-compliant due to making claims that differ to the claims listed on your ARTG entry.
Rather than double handling, it is far more efficient and cost effective to ensure your listings contain only Permitted Indications and that your labels match the updated listing from September 2020.
With this in mind, the overall deadline for Permitted Indications is actually far sooner than you might expect.
TGA Deadline #2: Permitted Indications
This change to health product regulations is suggested to be one of the biggest changes to this industry in the last 25 years.
Although the TGA previously extended an earlier deadline, we know now that on 6 March 2021 the TGA will immediately AUTOMATICALLY CANCEL listings of all products on the ARTG that don’t include Permitted Indications.
On the 6 March 2021, all products on the ARTG MUST ONLY contain ‘Permitted Indications’, as determined by the TGA. This means that any products with the old Standard Indications or Specific Indications need to be updated to Permitted Indications. Anything else is considered unacceptable.
What happens if you don’t update to Permitted Indications?
If by 6 March 2021, your products haven’t been updated to ‘Permitted Indications’ only, they will be AUTOMATICALLY CANCELLED by the TGA. This means the product immediately becomes ILLEGAL to sell. All label and marketing claims must also comply.
So If you think March 2021 seems a way off, let’s get real for a moment. As we discussed earlier, the deadline is really more like September this year.
That’s now less than two months away.
What do I need to do, and by when?
Even though March 2021 is the deadline, your manufacturing scheduling needs to be considered.
Because of the mandatory TGO 92 Labelling Order, because third party manufacturing has an average 12-16 week lead time, and because the industry slows down over the Christmas/New Year period, your attention needs to be focused NOW.
We are currently experiencing a surge in demand for our services as many brands realise the implications this will have on their business. It will be impossible to accommodate all requests for support as the deadline gets closer.
Don’t miss out and have your products cancelled from the ARTG, making them illegal to sell and having to write off your stock.
Take action NOW
We strongly suggest you TAKE ACTION NOW to reduce disruption and avoid cancellation of your product(s).
At Atomic Regs, we’re ready to help you ensure your products are compliant. Take the burden off your team and free them up so they can focus on pushing the company forward.
Get in touch now before it’s too late.
DO IT ONCE. DO IT RIGHT. DO IT NOW.