Photo: AJU
A sign of the digital times, or more red flags?
PRODUCT INSERT CHANGES
Australia’s Therapeutic Goods Administration (TGA) has long required that administered injectable medicine products include a hard copy of the product information (PI) in the packaging.
For more than 30 years, under the powers of Section 28(2B) of the Therapeutic Goods Act, the TGA has required a printed version of the PI (often referred to as the approved “labelling”) to be available as a package leaflet in the marketing of injectable products.
Of course, ask most people if they have ever seen or received any of these leaflets from their local GP, and you will get a confused look. Nonetheless, they were still available if requested (or demanded).
It was often a good tool used by the pro-choice movement to educate people on any risks that may be associated with any jab, the ingredients used in the injectable products, and more.
For healthcare professionals, their rationale was that leaflets provide them with immediate access to information relating to the correct administration of the product (i.e. routes of administration, reconstitution/dilution requirements, incompatibilities etc) and the safety profile associated with use.
But, after broad consultation last year, the TGA will drop the requirement for PI to be included in packaging for injectable products administered by healthcare professionals.
“From 1 September 2023, printed Product Information (PI) inserts won’t be required in the packaging of injectable medicines administered by health professionals.”
Yes, in response to ‘broad stakeholder consultation’ (you can fill in the blanks there), the TGA will cease mandatory requirements for package leaflets.
They say due to ‘the growth of the internet’ and ‘cloud-based software’, the original printed information should be entirely replaced by “electronic distribution channels”.
In other words, a doctor will tell you ‘go to the website and leave me alone’.
The specific conditions included in these new changes are:
- The change applies only to products administered by healthcare professionals. Products that are self-administered, or can be administered by healthcare practitioners or patients, are still required to include a package leaflet of the PI; and
- The TGA retains the authority to impose the PI package insert requirement where they consider it necessary for the ‘safe and effective’ use of a product.
They also say there will be advantages for production costs due to the dramatic reductions in physical resource requirements (paper), with ‘corresponding benefits’ to the ‘environmental footprint’.
Ah yes, we have to throw in the old ‘saving the planet’ green pitch as the cherry on top of the cake.
I have a hard enough time finding the correct FULL product pamphlets relating to vaccines, so we can imagine how many people (who may be less technological literate as myself) will be left in the dark.
What do they have to hide that they would be making these changes right now?
Ahead of universal mRNA vaccine trials, calls for new boosters, and more. Very interesting.
It also sounds familiar to everything else we have been witnessing over the past few years in the transition away from the physical, including cashless pushes, the end of land ownership papers and more.
And is a shady testament to changes they have been making in regards to the removal or changing to injectable product data and information.
SUSPICIOUS REPORTING
The reason as to why these changes are a red flag all situate around the fact that the TGA and health official lackies have repeatedly covered up, altered, and downplayed injectable product data.
Let’s not forget that Australia’s COVID jab adverse events are significantly higher than EVERY other vaccine COMBINED, and injection deaths are at least 80 times higher than reported.
Just recently, the TGA announced that reports on myocarditis and pericarditis cases following mRNA-based COVID-19 vaccines are not necessary anymore and will no longer be provided.
Further hiding and downplaying the impacts of the biological injectables they let loose on us all.
The TGA, out ‘national drug authority’, says this is because ‘the rates have stabilised’, but they will ‘continue to monitor and review these adverse effects and will communicate any updated safety advice’.
Great, we’ll just leave it to you then! Sounds good!
We have also seen reporting on state levels experience the same type of ‘funny business’, including in NSW, where earlier this year the Health Department removed vaccine status from hospitalisation data.
This followed the overwhelming majority of patients being administered falling under the “vaccinated” category, and with the reasoning ‘well, everyone’s got one now, so we can’t really tell’, they removed it.
‘Can’t really tell’ is a classic theme for the NSW government.
Remember when they quietly announced one morning in 2021 that they would re-classify COVID death statistics to include ‘died with’, not just ‘died from’? The reasoning? They couldn’t determine differences!
Not to mention that over 90% of people who were hospitalised with ‘COVID-19’ had two or more co-morbidities recorded when they were checked in suffering from ‘the virus’.
Once again, as we have repeatedly witnessed over the past few years, health authorities are back again to make things just that little bit more difficult to determine, while covering their tracks even more.
What do you think about all of these changes?
Should doctors be required to provide a pamphlet to each individual physically?
Is the excuse for removal of adverse event data from reporting good enough?
Be sure to leave your thoughts down below!
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Most people who get the deadly poison would not bother to read any leaflets anyway, same with any medication they are given, they “trust” their “gods” (doctors and politicians) to keep them safe. But we must encourage those who think they need any vaccines to ask for a print out from the doctors computer and to discuss the possibilities of adverse reactions to give complete “informed” consent.
Also to this the product inserts were missing in packets for HI blood pressure tables I collected last year I asked the chemist and was told they do not provide that information anymore,.. I questioned why, and could it she find out what contraindications there are or what ingredients are int his drug… NO, cannot, so people / patients are forced to trust their GP>>??? And or the chemist,. who just sells the package and asks NO questions,. suffice to say these to lower HI BP did exactly the opposite the Patient was feeling worse week after week and on checking BP at home was at 220???? A call to emergency doctor and their simple reply was stop taking right away and see you GP,.. no comment when saying ANY visit to this GP is a minimum 14 days.. SO get back onto healthy food and stay away from big pharma… there ARE ways to reduce HI BP naturally…. which I am not permitted to speak about
A proper chemist knows more about medications than a doctor, so find one that will tell you. And yes I agree better to treat naturally with fresh wholefoods, preferably organic, herbs and homeopathics.
Also hibiscus tea is supposedly able to lower bp, and no salt in diet.
Actually if you watch the salt video by Barbara O’Neill you’ll see what the salt problem actually is – we should be having Celtic salt, not table salt. Massive difference in how the cell responds to absorbing the minerals.
Regarding salt must watch is a video by Barbara O’Neill explaining how vital Celtic salt is for our cell health. It’s table salt- highly interfered with that does the damage
I don’t care any more. If the Covid-vaxxed still haven’t cottoned on to the dangers of vaccines and plan to accept any future tech-injectables, then they wouldn’t want to read the inserts anyway.
And the rest of us who will refuse these injections don’t need the inserts.
No info – no can do. Good luck to anyone who ignores that. Of course, the provided info is just one set of data to investigate further. There will be other avenues to check!
Incredible. We don’t take any medication without researching it but this has caused a huge problem with our doctor. My husband stopped taking the Statin and Melformin prescribed by his Doctor. Plus the both of us refused the Vax and this year the new Shingrix vaccine. Well our Doctor recently threw her hands into the air saying as he is refusing to take the medications she’s prescribed he needed to find another Doctor. We had tried going with any Doctor within the Practice but he said he couldn’t as it would create issues between the Doctors, so more than 12 months previous, we attempted to change Doctors. Now this year he was told he had to find a new Doctor outside of the Practice. It all booked down to the point that we had to take the medication prescribed. Both of us had attempted previously to start Statins due to the aching pain we were both experiencing. Stopping Metaformin was because of everything both of us were seeing in our research. I didn’t help the situation as I had issues with my teeth over the pàst four years. I had two broken teeth and my dentist bill simply was increasing annually. On changing Dentist they carried out appropriate x-rays and I was told my teeth were rotting from the inside out. I had been on Prolia over ten years for my osteoarthritis. Due to needing two broken teeth removed surgically I had my last Prolia shot March 2023. After having all but six teeth removed with surgery, I decided to not go back on Prolia. That didn’t go down well either. It all boils down to Doctors’ attitude that they know best, when 9/10 they don’t. They don’t like us doing our own research and making decisions they don’t agree with. Even though we the Patient, do have rights. On is to refusing to take a medications. Not having info pamphlets in vaccines and other meds is going to be dangerous. BTW my Anaesthetist when my teeth were removed said I was in except health for my heart and BP even after ECG. I had stopped my Statin 12 months previously. Touch wood my heart is ok. It’s my bones that are letting me down, I am 71 and we have no living family, it’s just my husband and myself.