REG 174 for Pfizer COVID-19 mRNA Vaccine BNT162b2 to be corrected

Bartholomeus Lakeman (Account suspended) made this Freedom of Information request to Medicines and Healthcare Products Regulatory Agency

This request has been closed to new correspondence. Contact us if you think it should be reopened.

Bartholomeus Lakeman (Account suspended)

Dear Medicines and Healthcare products Regulatory Agency,

In REG 174 for Pfizer COVID-19 mRNA Vaccine BNT162b2; under 5.2 Pharmacokinetic properties it states "Not Applicable"
Herewith does MHRA suggest that the novel mRNA COVID vaccines behave like “traditional” vaccines and the vaccine spike protein — responsible for infection and its most severe symptoms — would remain mostly in the vaccination site at the shoulder muscle.

However, there is a Pharmacokinetic property study done “2.6.5B Pharmacokinetics: Organ distribution. Test Article Labelled LNP mRNA formulation containing ALC-0315 and ALC 0159. Report number 185350” see https://www.docdroid.net/xq0Z8B0/pfizer-...
This Japanese data shows that the spike protein of the Pfizer ‘vaccine’ gets into the blood where it circulates for several days post-vaccination and then accumulated in organs and tissues including the spleen, bone marrow, the liver, adrenal glands, and in the ovaries.
Once in circulation, the spike protein can attach to specific ACE2 receptors that are on blood platelets and the cells that line blood vessels. This can either cause platelets to clump, and that can lead to clotting. It can also lead to bleeding.

This study looked at the vaccine distribution (as of ALC 0315/0159 plasma level) in about 45 organs were measured over time intervals of 15 min, 1hr, 2hr, 4hr, 8hr, 24hr and 48 hr. Pharmacokinetic studies have also been done over the days up to a 9 days period.

The study shows that in many organs the vaccine plasma level keeps rising after 2 days (concentration (ug lipid equivalent/g [or mL]: males and females combined) (ranking) Liver (24.3); Spleen (23.4); Adrenaline glands (18.2); Ovarium (12.3); Bone marrow (3,77); Pancreas (0.6); Uterus (0.5); Testes (0.3); Eyes (0.1)
To note is that the Adrenaline glands being affected by high plasma levels will cause an overall organ stress; which in turn affects particular the immune and the nervous system.

Compare that to Pfizer vaccine's Adverse Drug Reaction (see yellow cards of 21 May) in related organs (ranking in % of vaccine doses): Nervous system disorders 0.14%; Muscle & tissue disorders 0.1%; Gastrointestinal disorders 0.08%; Skin disorders 0.06%; Respiratory disorders 0.035%; Eye disorders 0.012%; Blood disorders 0.026%; Infections 0.02%; Cardiac disorder 0.01%; Reproductive & breast disorder 0.0116%

Further it is shown that the COVID-19 mRNA Vaccine BNT162b2 is excreted in human milk: babies got Thrombotic Thrombocytopenic Purpura and died.

Moreover, there is a coloration between the Pharmacokinetics and the vaccine injuries.
Therefor significant changes have to be made in Reg 174 or better due to the seriousness of the found injuries; it should be withdrawn.

Question: In case MHRA does (according to the above findings) not amend or withdrawn its current version: please state why and which study supports such reasoning

Yours faithfully,

Bartholomeus Lakeman

MHRA Customer Services, Medicines and Healthcare Products Regulatory Agency

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MHRA Customer Services, Medicines and Healthcare Products Regulatory Agency

 

 

Our Ref: FOI 21/611

       

Dear Bartholomeus Lakeman,

       

RE:  REQUEST UNDER THE FREEDOM OF INFORMATION ACT 2000

        

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Bartholomeus Lakeman (Account suspended)

Dear MHRA Customer Services,
Please do integrate in our Ref: FOI 21/611 the following information:

European Medicines Agency (EMA) reviewers revealed Pfizer didn’t thoroughly examine biodistribution and pharmacokinetics issues relating to its vaccine before submitting the vaccine to the EMA. Its reviewers shared with the HMRA this explicit admission: “No traditional pharmacokinetic or biodistribution studies have been performed with the vaccine candidate BNT162b2.”
In fact, in key studies — called biodistribution studies, which are designed to test where an injected compound moves throughout the body — the time course of its absorption, bioavailability, distribution, metabolism and excretion travels in the body, and which tissues or organs it accumulates in — Pfizer did not use the commercial vaccine (BNT162b2) but instead relied on a “surrogate” mRNA that produced the luciferase protein.
Regulatory documents also show Pfizer did not follow industry-standard quality management practices during preclinical toxicology studies of its vaccine, as key studies did not meet good laboratory practice (GLP). GLPs, are of paramount importance for quality and ultimately for patient safety. If such important steps are skipped, the risk-benefit analysis would need to be compelling.”
Additionally, the EMA document states, “Biodistribution: Several literature reports indicate that LNP-formulated RNAs can distribute rather non-specifically to several organs such as spleen, heart, kidney, lung and brain. In line with this, results from the newly transmitted study 185350 indicate a broader biodistribution pattern.” This EMA observation corresponds with a growing number of adverse events and aligns with data TrialSite obtained through FOIA showing concentrations of LNP-formulated RNAs in the spleen, ovaries, other tissues and organs.
A quick review the Toxicology Section (2.3.3) of the EMA Assessment Report on Comirnaty (BNT162b2) issued on 19 Feb. 2021, raises concerns about data applicability of preclinical study findings to clinical use: “To determine the biodistribution of the LNP-formulated modified mRNA (modRNA), the applicant did study distribution of the modRNA in two different non-GLP studies, in mice and rats, and determined the biodistribution of a surrogate luciferase modRNA. Thus, one might question the validity and applicability of non-GLP studies conducted using a variant of the subject mRNA vaccine. “In addition, no genotoxicity data were provided to EMA [& to MHRA].”

Pre-clinical studies showing BNT162b2’s active part (mRNA-lipid nanoparticles) — which produce the spike protein — did not stay at the injection site and surrounding lymphoid tissue as scientists originally theorized, but spread widely throughout the body and accumulated in various organs, including the ovaries and spleen. Research suggests this could lead to the production of spike protein in unintended places, including the brain, ovaries and spleen, which may cause the immune system to attack organs and tissues resulting in damage, and raises serious questions about genotoxicity and reproductive toxicity risks associated with the vaccine.

Whilst MHRA REG 174 (on BNT162b2) states that the studies performed and submitted by Pfizer all fulfilled the GLP standards: they were actually non-GLP. Moreover, MHRA provided Pfizer an exception to this GLP regulatory rule: despite that BNT162b is based on a radically new life science-based technology, and that Pfizer having been fined several times for being dishonest in the data they supplied.
Now that the MHRA is explicitly informed about Pfizer having withheld, forged and frauded essential GLP data concerning its vaccine biodistribution and pharmacokinetics; MHRA’ conclusion that BNT162b is safe is false. The MHRA should interpretate that its Adverse Drug Reaction results on its yellow card report to be related to BNT162b2’ biodistribution and pharmacokinetics.
Whereas Pfizer’s vaccine BNT162b’s risk-benefit analysis is negative; therefor should BNT162b’ Emergency Use Authorization approval be withdrawn.
Yet if the MHRA does not do make such interpretation and withdraw: then what are MHRA’ reasons?

Yours sincerely,
Bartholomeus Lakeman

MHRA Customer Services, Medicines and Healthcare Products Regulatory Agency

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Bartholomeus Lakeman (Account suspended)

Dear Medicines and Healthcare Products Regulatory Agency,

Please pass this on to the person who conducts Freedom of Information reviews.

I am writing to request an internal review of Medicines and Healthcare Products Regulatory Agency's handling of my FOI request 'REG 174 for Pfizer COVID-19 mRNA Vaccine BNT162b2 to be corrected'.

FOI 21/611 of 2 June is of a similar nature as FOI #712098 dated 10 Dec- and as FOI 20/574 of 17 Dec. Which MHRA constructively failed to answered; as it did so by Pfizer’s own publication in the New England Journal of Medicine (NEJM) which in April was heavily critiqued for it being without proof of evidence. And in a May 28, 2021, letter to the editor of NEJM, Drs. Ira Bernstein and Sanja Jovanovic and Deann McLeod, HBSc, of Toronto, pointed this out by highlighting that preliminary safety studies published in the NEJM in April 2021 were in error by including “clinically unrecognized pregnancies” in them. And MHRA used said Pfizer publication despite it being contrary to the evidences. E.g., the BNT162b2’ training antibodies to attack syncytin-1 is proven by the in the yellow cards and VAERS high number reported miscarriages, birth defects, infertility and menstrual dysfunctions: The addition of mNeonGreen to scan whether one is vaccinated has been acknowledged in an American Court case and by the European Medicine Agency: Regarding balancing benefits with risk: MHRA and its co-regulators have no criteria for when the number of serious injuries and deaths being reported are too high (for to retract its EUA), e.g.,
The HMRA Yellow Card system had, as of June 9, 2021, received 276,867 adverse event reports following COVID “vaccination,” including 1,332 deaths
The U.S. Vaccine Adverse Events Reporting System (VAERS) as of June 11, 2021, posted 358,379 adverse events including 29,871 serious injuries and 5,993 deaths from the COVID-19 jabs
EudraVigilance (covering 27 European countries) database of adverse drug reactions from COVID shots as of 19 June reported 1,509,266 injuries, of which 753,657 are listed as “serious”, and 15,472 deaths.
According to a report by the Israeli People Committee, a civilian body of health experts, "there has never been a vaccine that has harmed as many people." Their data show that vaccinated boys and men between the ages of 16 and 24 have 25 times the rate of myocarditis than normal. And yet MHRA coerces young men and boys to be inoculated with this gene therapy vaccine.

Nevertheless, pandemic vaccine makers are shielded from financial liability. The only way you can sue is if you can prove "wilful misconduct," such as deliberate deception, fraudulent behaviour or hiding relevant information. To get around this, vaccine makers did not look for certain problems, e.g., leaving out its product's biodistribution, and not reporting the reproductive toxicity of its product producing spike protein S. Since they didn't look, they can with a straight face say they "didn't know" the shot might cause reproductive failure. The thing is, they should have suspected it, as Pfizer's biodistribution data show it accumulates in women's ovaries and Data suggest the miscarriage rate among women who get the COVID "vaccine" within the first 20 weeks of pregnancy is 82%. The normal rate is 10%, so this is no minor increase. Infertility will be far more difficult to ascertain, and could take decades.

There is mounting evidence that MHRA and DHSC will use any & all means to have the whole population inoculated with a ‘Covid-19 vaccine’ as a continuum with its boosters for the alleged delta and other variations of SARS-CoV-2 spike protein S. The most current version of the Emergency Use Authorization (EUA) that governs these COVID shots reveals the MHRA opted not to require stringent post-vaccination data collection and evaluation, even though they had the power to do so. Subsequently MHRA will neither put up a red flag nor will they take any liability to the number of crippling morbidities and deaths being reported; as to MHRA and DHSC, the public health care is only an economic and political commodity e.g., Pfizer is set to haul in $26 billion from its COVID vaccines this year and COVID vaccine manufacturing is churning out billionaires whose annual salaries are multiples of a decade of compensation payouts to some dozens of their victims.

A full history of my FOI request and all correspondence is available on the Internet at this address: https://www.whatdotheyknow.com/request/r...

Yours faithfully,
Bartholomeus Lakeman

MHRA Customer Services, Medicines and Healthcare Products Regulatory Agency

Thank you for your email.  This auto-response is to inform you that your
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Pharmacovigilanceservice, Medicines and Healthcare Products Regulatory Agency

1 Attachment

Dear Mr Lakeman,

Please find attached the response to your FOI request.

Kind regards,

 

FOI Team

Vigilance and Risk Management of Medicines Division

Medicines and Healthcare Products Regulatory Agency
10 South Colonnade, Canary Wharf, London E14 4PU

 

 

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Bartholomeus Lakeman (Account suspended)

Dear Medicines and Healthcare Products Regulatory Agency,

Please pass this on to the person who conducts Freedom of Information reviews.

I am writing to request an internal review of Medicines and Healthcare Products Regulatory Agency's handling of my FOI request 'REG 174 for Pfizer COVID-19 mRNA Vaccine BNT162b2 to be corrected'.

That the WHO has exempted vaccine from a biodistribution-analyses along with vaccine manufactures being exempted from its product liability is great for the vaccine industry’ investors e.g., Pfizer is set to haul in $26 billion in 2021 alone from its COVID vaccines and its manufacturing is churning out billionaires whose annual salaries are multiples of a decade of compensation pay-outs to their victims. Be it that this commercial success might benefit some members of DHSC and MHRA; it does not allow the MHRA to usurp the public health care into an economic commodity, to exempt itself from fulfilling its oath of office, its responsibility to the public health care and it does not allow the MHRA to answer this FOI in a manner that uphold the vaccine manufactures’ product liability as by copying and pasting that what suits Pfizer. MHRA’ oath of office compels that it answers this FOI by the evidence provided by the scientific community.

The mRNA vaccine's original description was a ‘gene therapy’, yet because of said WHO’ exemptions it has been nominated as a ‘vaccine’. However, none of the Covid vaccines fulfil the criteria of a vaccine. Whilst Pfizer claims its vaccine is 95% effective, this is the Relative Risk Reduction (that of flu symptoms) which was based on 16 cases occurring in its placebo group, while none were recorded in its vaccine group. Yet, since there were about 1000 placebo recipients, fewer than 2% of the placebo group actually tested positive for COVID-19. That 2% of the fully vaccinated avoided COVID has to be compared to that 98% of the vaccinated would not have gotten COVID anyway. Pfizer’s vaccine’s Absolute Risk Reduction -which is far more relevant for public health measures- is less than 1%; see Peter Doshi, associate professor at the University of Maryland School of Pharmacy and BMJ’ senior editor. And a European study calculated the number needed to vaccinate (NNTV) from a large Israeli field study to prevent one death. It also accessed the Adverse Drug Reactions (ADR) database of the European Medicines Agency (EMA) and of the Dutch National Register (lareb.nl) to extract the number of cases reporting severe side effects and the number of cases with fatal side effects. Result: Pfizer’s mRNA vaccine NNTV is between 200–700 to prevent one COVID-case, while the NNTV to prevent one COVID-death is between 9000 and 50,000 vaccinations (95% confidence interval), with 16,000 as a point estimate. The number of cases experiencing an ADR has been reported to be 7 per 1000 vaccinations. Currently, there are 0.16 serious side effects per 1000 vaccinations, and the number of fatal side effects is at 0.411 per 1000 vaccinations. For 3 deaths prevented by vaccination we have to accept 2 deaths or more inflicted by vaccination; see https://www.mdpi.com/2076-393X/9/7/693. Further, vaccine’s benefits are rare and short-lived (Pfizer admitted that ‘boosters are required as antibody blood concentration wanes’), side effects are common and long-term side effects can also appear after several years. Herewith is the MHRA required to put on the ‘Covid vaccines’ stringent post-vaccination data collection and evaluation.

Yet MHRA states “The data do not allow a judgment on the distribution of the mRNA component or expression and distribution of the encoded COVID-19 spike protein. Whilst the lipid was widely distributed, the amounts outside the injection site and liver were small and were not associated with any adverse effects. In the repeated dose preclinical toxicity studies [in rats], no adverse effects outside of the expected inflammation associated with an immune response were detected [in 48 hrs].” Which is a copy of what Pfizer has published; whilst its raw product data has not been seen by MHRA. Herewith failed MHRA to take sufficient note of the Japanese Pfizer biodistribution study which includes studies from Germany, the UK, California, Groton Connecticut and China. And it involves tests on rat, mouse, monkey and human tissues. In May/June 2021 the data of this study was reviewed, commissioned by the Canadian Government, by Byram Bridle, a viral immunologist and associate professor at University of Guelph, Ontario. Who confirms that the vaccine’s nanoparticles and its provoked Covid spike protein do circulate for several days post-vaccination and then in quite high concentrations accumulates in organs e.g., the spleen, bone marrow, the liver, adrenal glands and ovaries. The study proves that the spike protein is a pathogenic protein and a toxin that can cause damage in our body if it gets into circulation. “If you find lipid nanoparticles in an organ or tissue, that tells you the drug got to that location” said Dr. Robert Malone, creator of mRNA vaccine technology, and he said there needed to be monitoring of vaccine recipients for leukaemia and lymphomas which often don’t show up for six months to three or nine years down the road. That said drug accumulates in -and harms- the organs has been supported by several other studies and scientist e.g., Brigham and Women’s Hospital and the Harvard Medical School (http://academic.oup.com/cid/advance-arti... 10.1093/cid/ciab465/6279075) and Nature Neuroscience “The S1 protein of SARS-CoV-2 crosses the blood–brain barrier in mice” (https://www.nature.com/articles/s41593-0...) and Stephanie Seneff, senior research scientists at Massachusetts Institute of Technology, and Dr. J. Patrick Whelan, a paediatric rheumatologist warned the U.S. Food and Drug Administration (FDA) in December that mRNA vaccines could cause microvascular injury to the brain, heart, liver and kidneys in ways not assessed in Pfizer’s safety trials. Further research shows that the spike protein is also expelled in breast milk, which can result in bleeding and/or blood clots in the baby.

Dr. Raine of the MHRA has been informed about said distribution risk by receiving on 9 June 2012 “Urgent preliminary report of Yellow Card data up to 26th May 2021” analysed by Tess Lawry, Director of the Evidence-based Medicine Consultancy Ltd and EbMC Squared CiC. It states i.e., “13,766 bleeding, clotting and ischaemic ADRs were identified – 856 of which were fatal. Government reports have highlighted the occurrence of cerebral venous sinus thrombosis, apparently accounting for 24 fatalities and 226 ADRs up to the 26 May 2021. However, our analysis indicates that thromboembolic ADRs have been reported in almost every vein and artery, including large vessels like the aorta, and in every organ including other parts of the brain, lungs, heart, spleen, kidneys, ovaries and liver, with life-threatening and life-changing consequences. The most common Yellow Card categories affected by these sorts of ADRs were the nervous system (152 fatalities, mainly from brain bleeds and clots), respiratory (with 103 fatalities, mainly from pulmonary thromboembolism) and cardiac categories (81 fatalities).” Which confirms that the Covid vaccines products distribute itself via the blood, into every organ and in particular into the ovaries. As her report also states “Given that vaccinated pregnant women comprise a small proportion of the vaccinated population in the UK up to 26 May 2021, there appear to be a high number of Pregnancy ADRs (307 ADRs), including one maternal death, 12 stillbirths (reported as 6 stillbirths and 6 foetal deaths, but only 3 listed as fatal(?)), one new-born death following preterm birth, and 150 spontaneous abortions.” And a study published in the New England Journal of Medicine reveals that when pregnant women are given a covid vaccine during their first or second trimesters, they suffer an 82% spontaneous abortion rate, killing 4 out of 5 unborn babies.

To the question regarding adverse reactions and the risk benefit ratio; MHRA states “Generally, these happen shortly after the vaccination and are not associated with more serious or lasting illness. In clinical trials, the Pfizer/BioNTech vaccine has demonstrated very high levels of protection against symptomatic infection.” Again a copy from Pfizer; herewith turns the MHRA a blind eye to the risk being exposed by:
MHRA’ Yellow Card system had, as of June 9, 2021, received 276,867 adverse event reports following COVID “vaccination,” including 1,332 deaths; further see Tess Lawry’ report.
The U.S. Vaccine Adverse Events Reporting System (VAERS) as of June 11, 2021, posted 358,379 adverse events including 29,871 serious injuries and 5,993 deaths from the COVID-19 jabs
EudraVigilance (covering 27 European countries) database of adverse drug reactions from COVID shots as of 19 June reported 1,509,266 injuries, of which 753,657 are listed as “serious”, and 15,472 deaths; further see aforementioned European study analysing this report.
According to a report by the Israeli People Committee, a civilian body of health experts, "there has never been a vaccine that has harmed as many people." Their data show that vaccinated boys and men between the ages of 16 and 24 have 25 times the rate of myocarditis than normal. And yet in the UK are young men and boys coerced to be inoculated with this mRNA vaccine.
Further there are numerous breakthrough cases; some studies (e.g., Israel) show that 70% of the new Covid-19 cases have been fully vaccinated; and see said European study about the NNTV.

Whilst the scientific community and the ADR reports have proven that the vaccine’s spike protein gets into circulation and can cross the blood-brain barrier by which it is almost entirely responsible for the reported damage to the cardiovascular system, the brain and other organs; the MHRA cannot continue to copy Pfizer’ statements in order to get the whole population inoculated with a drug that poses the same or a higher risk as Covid-19.
MHRA’ oath of office, its mission statement and its responsibility to the British people and citizens; oblige the MHRA to answer this FOI out of an independent scientific source.

A full history of my FOI request and all correspondence is available on the Internet at this address: https://www.whatdotheyknow.com/request/r...

Yours faithfully,
Bartholomeus Lakeman

MHRA Customer Services, Medicines and Healthcare Products Regulatory Agency

Thank you for your email.  This auto-response is to inform you that your
email has been received and will be reviewed by our Customer Service Team.
We will respond to you as soon as possible. 

 

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Medicines and Healthcare products Regulatory Agency
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London 
E14 4PU
gov.uk/mhra
Stay connected 
 
For information on how the Agency uses your personal data and your data
protection rights, please see our three centres’ Privacy Notices: MHRA,
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The UK has left the EU, and the transition period ends on 31 December
2020. Our [1]guidance and information can be accessed here. 

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MHRA Customer Services, Medicines and Healthcare Products Regulatory Agency

Internal Review of FOI 21/611

Dear Bartholomeus Lakeman,

Thank you for your email.

We confirm that an internal review will be carried out on FOI 21/611. We normally aim to respond to requests for internal review within 20 working days of receipt. However, due to high volumes of queries we are currently receiving related to COVID-19 please be aware that responses may take longer than usual.  

Kind Regards  

MHRA Customer Service Centre

Medicines and Healthcare products Regulatory Agency
10 South Colonnade, Canary Wharf, London E14 4PU

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Pharmacovigilanceservice, Medicines and Healthcare Products Regulatory Agency

2 Attachments

Dear Mr Lakeman,

Please find the attached in response to your internal review request.

Kind regards,
FOI Team
Vigilance and Risk Management of Medicines Division
Medicines and Healthcare Products Regulatory Agency
10 South Colonnade, Canary Wharf, London E14 4PU

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Bartholomeus Lakeman (Account suspended)

Dear Pharmacovigilanceservice,
MHRA’ mission statement “is to protect and improve patient health by enabling the earliest access to and high-quality supply of safe, effective and innovative medical products through proportionate, data-driven assessment of risks and benefits.” Which goes along with MHRA’ self-imposed duties e.g., “taking action to safeguard public health”; this within “the culture within the Agency allows us to listen to and respond to the voice of patients more effectively”; “preparing, approving, holding and distributing standard preparations of biological substances”; “providing, or arranging for, the provision of laboratory testing facilities for the testing of biological substances, carrying out such tests, examining records of manufacture and quality control and reporting on the results."

In spite of that MHRA is for about 75% funded by the pharmaceutical industry, according to its abovementioned mission and duties to the public in regards to Pfizer’ BNT162b2 risks: MHRA is under the obligation to investigate its Pharmacokinetic properties (REG der 174: 5.2). In particular as Regulatory documents (e.g., EMA Toxicology Section (2.3.3) show that Pfizer, during preclinical toxicology studies of its vaccine did not follow industry-standard quality management practices, the EMA states, “Biodistribution: Several literature reports indicate that LNP-formulated RNAs can distribute to several organs such as spleen, heart, kidney, lung and brain; which explains that most injuries or deaths occur about 48 hrs after the inoculation of BNT162b2.

This FOI appeals to MHRA's its duty “to take action to safeguard public health”, “arranging for, the provision of laboratory testing facilities for the testing of biological substances, carrying out such tests, examining records of manufacture and quality control and reporting on the results"
Consequently, The MHRA’ review response has to be re-examined

Yours sincerely,
Bartholomeus Lakeman

Pharmacovigilanceservice, Medicines and Healthcare Products Regulatory Agency

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Kind Regards,
Pharmacovigilance Service Team
Vigilance and Risk Management of Medicines
MHRA
10 South Colonnade
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London
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Pharmacovigilanceservice, Medicines and Healthcare Products Regulatory Agency

Dear Mr Lakeman,

If you are dissatisfied with our response to your request for an internal review, you may write to the Information Commissioner at:

The Information Commissioner’s Office
Wycliffe House
Water Lane
Wilmslow
Cheshire
SK9 5AF
https://ico.org.uk/

They will make a decision on whether or not we have interpreted the Freedom of Information Act correctly in handling your request."

Kind regards,

FOI Team
Vigilance and Risk Management of Medicines Division
Medicines and Healthcare Products Regulatory Agency
10 South Colonnade, Canary Wharf, London E14 4PU

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