Thank you for clarifying that, you are right, registering a medicine is different from a medical device. Back in my day when I listed a medicine, it took us approx 3-4 months, although, the difference being that it was a sunscreen, hence a different class. Being the first natural sunscreen to ever be invented and registered, we were put through an enormous amount of clinical testing , more than usual, to prove no toxicity, efficacy etc. I recall that we had a pre registration agreement with the TGA, where we could sell our goods pending the outcome of all trials and based on the no side effects study. That was back in the day when things were different with our regulatory bodies. There are accelerated applications for Europe, and especially for a medicine such as this that will be sought after and required by many people. Well done to your team, I am quietly excited about this product, and wish we could buy some now!
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