Synthetic PREP Act for European Union
Revisiting leaked EMA emails at the time of the fake "approval" of mRNA shots, including the list of EMA staff involved (knowingly or not) in the public deception.
This article will provide some new perspective on old news, which I reported pre-Substack days when I was publishing videos on Bitchute. I also include a previously unpublished list of EMA actors that you can download in the article below.
Letters from the Underworld - Part 1
Letters from the Underworld - Part 2
Letters from the Underworld - Part 3
I was asked a question about this by a team of lawyers I am assisting in Europe, and I think this may be important for my readers from the European Union. The significance of what these materials reveal is that the upper echelons of EU have created a “synthetic PREP Act” - a perversely incentivized, lawless, unregulated, liability-free zone for “medikill” products to be pushed onto unsuspecting public.
You are likely aware of the now well-publicized fact that Pfizer made significant manufacturing process changes when scaling up the mRNA bullshit manufacturing while the fake "clinical trials" were still ongoing. The so-called Process 1 to Process 2 switch.
I am putting the “clinical trials” in quotes because no valid clinical trials were conducted for the covid shots due to the non-investigational status of the EUA countermeasures. In general no valid clinical trials have ever been conducted for any vaccines, as meticulously traced by Katherine Watt.
A “real” FDA-approved product can only exist if an investigational drug or device, has undergone a full set of prescribed pre-clinical and clinical testing and the manufacturer has complied with the cGxP regulations while being subject to the Investigational Review Board (IRB), informed consent and other regulatory and ethical requirements put on the investigational products by the FDCA in an enforceable manner. That has NEVER happened for covid injections because no pharmaceutical regulations can be enforced for EUA Countermeasures during public health emergency (which is ongoing now to at least the end of 2029). If there is no enforcement of the law, there is no law!
What the FDA is claiming -”full approval” for covid vaxxes - is an impossibility.
Thus, whatever those drug injection parties with duped, poisoned and then abandoned “clinical trial” participants were for Pfizer, Moderna and other Warp Speeders, they were not legally regulated as clinical trials. At a minimum, trials conducted in the US are not valid clinical trials. Even if the trials could be claimed legitimate for those subjects enrolled ex-US, the trials and data produced in them were immaterial to the regulatory decisions about vaccine authorizations worldwide. Furthermore, the pharmaceutical regulations are already globally controlled. Mutual recognition agreements remove the national regulators and replace them with a global opaque bureaucracy.
For EU specifically, I have extensive evidence of what happened from the manufacturing review documents and emails that leaked from the EMA at the end of 2020, i.e., 2-3 weeks before the shots were deployed in the EU. These documents demonstrated that the fraud on the public was planned, orchestrated and committed by the very top of the EU/EMA.
Synthetic PREP Act:
One of the critical mechanisms of deception was tying all 27 EU Member States into one [blind] deal. All EU states (as all other countries) were forced to sign insanely predatory purchase contracts for covid injections, which removed individual authority of the states to enforce compliance with national pharmaceutical regulations and import-export laws, while prohibiting them from exercising sovereign national legislative authority with regard to pharmaceutical liability, and furthermore forced them to pledge state assets as collateral for pharma indemnification. This is insane beyond imaginable. No private pharmaceutical company has the kind of power needed to force sovereign states into signing away their sovereignty. This power can only be exerted by a very powerful global military force.
These contracts were allegedly negotiated by Ursula von-der-Lyingbitch by text messages with Albert Bourla that she subsequently lost and was never held accountable for. From the leaked EMA emails, it became evident that Ursula fraudulently induced all member states into the blind pact by promising that the vaccines in Europe will go through the Conditional Marketing Approval (CMA) regulatory pathway as opposed to the Emergency Authorization, i.e. the issue of Art 5(2) vs CMA:
Ursula worked hard, arm twisting the national health ministers to avoid the use of Art 5(2) at all cost. The Art 5(2) is an Emergency Authorization mechanism available individually to the Member States. This authorization is issued for a year only, it is issued by each state and each state can revoke it independently. The CMA is a pan-EU mechanism in which the individual states have no say. The CMA in EU, however is a non-emergency investigational pathway which, prior to 2020, had only been used for oncology drugs as a "right to try". It is similar to the Expanded Access Use (EAU, not to be confused with the EUA!) in the US. As it is spelled out in law, the CMA sounds like a much stronger regulation and compliance mechanism:
The important difference between Art 5(2) and CMA is that it puts liability onto the manufacturer, and that’s what Ursula promised to enforce via the use of the pan-EU CMA authorization:
However, in a classic bait-and-switch fraudulent inducement scheme she never meant to hold the pharmas to any of those promised CMA standards. She consolidated all member states under her control via her empty promises, and then forced them to sign the supply contracts waiving all the consumer safety enforcement regulations and laws in their countries. In effect, this removed any meaning from the CMA standards for consumer safety and manufacturer liability, because no enforcement = no law!
In reality, Ursula likely had not much to do with structuring these contracts, other than creating a “public health” cover story and twisting the arms of health ministers. These were military NATO agreements and the power they exerted ultimately emanated from the largest global military. Ursula texted with Bourla while NATO dumped a bunch of poison to its distribution facility in Germany, claiming this required “special skills” that only military has (yeah, right!):
all vaccines against Covid-19 that are administered in Germany come from a single transshipment center: the Bundeswehr's Supply and Maintenance Center for Medical Equipment in Quakenbrück.
It is likely that this NATO logistics site in Germany (which facilitates shipments of weapons bypassing all import-export regulations for normal goods) served most if not all EU. Note that immediately after the above linked article was published in our Covid Dossier, German Bundeswehr removed it from its page. Color me shocked. I re-linked an archived article.
More about military operation “covid” from the Covid Dossier:
The combination of the insane purchase contracts fronted by Ursula and “private pharmas” with NATO shipping the weaponry disguised as “vaccines” via their exclusive networks enabled the net effect of the “synthetic PREP Act” for EU and UK (and most other countries) - the evil pseudo-law, aka “license to kill” that technically exists only in the US.
It is also clear from the leaked emails that most of the EMA staff, even very senior, did not realize they were acting in a chemical weapons pantomime. They were frantically inventing the ways to make use of the Conditional Marketing Approval pathway in this situation, which had never been utilized (nor meant) for something like this:
While the staffers were running confused and panicked, all their activity amounted to generating a pile of paperwork to nowhere. None of the data produced in the fake approval process impacted already pre-determined decisions to deploy the mRNA shots. The EMA review staff objected to the approval, with many of the objections relating to the manufacturing process changes, but none of those objections were taken into any consideration for launch of the product. For example, a major issue was detected - the mRNA in the batches of Pfizer product was hugely variable, broken and unstable. The consequences to patients were unknown:
There were several Major Objections raised (any single one of these would have stopped any normal product approval):
This wasn’t limited to Process 1 and 2, there were hundreds of changes that in normal drug development would require running re-validation of manufacturing, comparability studies, etc. but none were done or required. Two weeks later the product was mass deployed in Europe and worldwide.
The regulators at the top were going to approve no matter what, and the only thing they were discussing among FDA, EMA and UK MHRA were the dates of launch, even before seeing ANY data. It is important to note that Trump was personally pushing for fake “approval” of his beautiful vaccines before Christmas:
…while Albert Bourla was lying to Peter Marks at FDA, telling him EMA wanted this approval even faster. EMA staffers were upset about this lying and bullying, but again, that didn’t make any difference:
I am including a previously unpublished list of all names and email addresses that leaked from the EMA (I extracted them from over 1000 pages of documentation). These people are witnesses to what happened and should be questioned. They should come forward as whistleblowers if they have any shreds of conscience left. Note that I am not doxing anyone as this info is in public domain since 2020:
Finally, this table is from a manufacturing variations report to EMA CHMP from Feb 2022. You can see how many manufacturing changes were made (most of them are major!), and you can see that there are still gaping holes in assessment, most of these processes are not validated, newly invented and proprietary (i.e. no standards exist):
Yet, nobody cares! It's immaterial to the continued authorization because there is no liability of the manufacturer to comply with any consumer safety law. That's the bait and switch. The entire "vaccine approval" is a fake theater.
The synthetic PREP Act facilitated by Ursula von der Leyen in EU achieved the same effect of the PREP Act in the US. Quoting
Katherine Watt:The PREP Act was written to block or preempt the authority of fact-finders (courts and legislatures); to block fact-finding processes (criminal prosecution, civil litigation, investigative/oversight hearings); and to preclude legal obligations to present valid evidence and meet standards of proof.
No one can be found in legal violation of a rule they were never required to comply with, nor can anyone be found to have failed to meet an evidentiary standard they were never required to meet.
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Art for today: Happy Goats, oil on panel, 11x14 in.
"The U.S. is an exception to the rule which holds in every country. The American Constitution states plainly that the Fed must be subject to Congress, so until that changes, expect obfuscation, lies and deflection.
...
These are the families who own the national debt of the United States, to whom we pay $1,000,000,000 in interest every single year. The U.S. Federal Reserve is privately owned by them.
How is that not slavery?
Here are our owners. First identified by Peter Kershaw in Economic Solutions, his research has been repeated so many times as to become a truism. You can easily find a fleshing out of their ownership and how it is spread across what funds.
The major shareholders (Class 'A' stock) of the Federal Reserve Bank System are identified as:
* Rothschild: London and Berlin
* Lazard Bros: Paris
* Israel Seiff: Italy
* Kuhn Loeb Company: Germany
* Warburg: Hamburg, Amsterdam, The Netherlands
* Lehman Bros: NY
* Goldman and Sachs: NY
* Rockefeller: NY
the balance of stock is owned by the major commercial member banks."
High Class Thieves and Satanists: How Central Banks Stole the Last 30 years.
Today the Fed is Gutting the Future of Gen-Z
https://elizabethnickson.substack.com/p/high-class-thieves-and-satanists
Ursula von-der-Lyingbitch indeed
Von der Leyen’s authoritarian plot National democracies will be subordinate to her Commission
Ukraine Hawk Who Heads European Commission Has a Nazi Pedigree She Does Not Want You to Know About
https://cynthiachung.substack.com/p/ukraine-hawk-who-heads-european-commission