B12 OTC Petition – The MHRA still dragging their heels and passing the buck…

Dec 11, 2022 | Petition, Raising awareness | 46 comments

Injectable B12 OTC Petition.

Thank you to each and everyone who has signed and shared our petition. Even though between us we haven’t reached our goal of accessing our B12 injections OTC in the UK yet, many more people now understand our plight.

So much of what thousands of people with B12 deficiency have said to their health professionals, GP’s, CCG’s, MP’s, newspapers etc, has  fallen on deaf ears. There are people, even in recent weeks having their essential treatment stopped due to the ignorance of this very common condition. Being told they no longer need B12 injections, just oral tablets – this is complete madness.

I regularly bother my MP about our situation, I also ask for meetings with people who can make change – if they want to. I have yet to get to another one of these since my meeting with Minister Jane Ellison back in July 2016. I chased my MP again last week and lo and behold we now, 14 months later – yes 14 months… have another response from the MHRA.

MP Jane Hunt, wrote the following on the 2nd of October 2021:

Dear Dr Raine,

Following on from our previous correspondence about B12, I have recently been informed by the former Parliamentary Under Secretary of State for Innovation, Lord Bethell, that the MHRA is in discussion with the companies that own the Marketing Authorisations about how the SPC’s could be updated to shorten the treatment interval which will allow prescribers greater flexibility for those who need shorter intervals between injections. I would like to express my support for such a move which will go some way to ensuring that those who require more frequent injections will be able to access them – an issue which I know is of great concern to many people with B12 deficiency – although I would hope that such a change would come alongside the removal of the classification of Prescription-Only Medicine from Injectable B12.I would, therefore, be interested to hear whether you have an expected timeframe for such a change to take place?


So after this long 14 months, Dr June Raine’s response is more positive than any other communication we have had from the MHRA but it is still a delaying, feet dragging, buck passing exercise. It’s beyond irritating when we know these big organisations can make decisions at lightening speed, but only when it suits them.

The MHRA reply  (I have made the text bold at pertinent points):

Dear Ms Hunt,

Injectable vitamin B12

Thank you for your follow up email with regard to Vitamin B12 injectables.

Please accept my sincere apologies for the delay in responding to this. We note we have recently also received a separate enquiry from your office on this issue which we will respond to formally.

Thank you for highlighting important concerns that you and your constituent have about the longstanding practice of prescription only supply of certain vitamins, with limited flexibility for patients.The work on this area has not progressed as swiftly as we would have liked due to the altered priorities through the pandemic, but we very much see the case for change. On re- classification, the risks of moving the decisions on what the patient needs away from medical professionals would require a careful exploration as well as a public consultation. However, as has been particularly valuable through the pandemic, once that prescribing decision has been made, the administration can be done by an alternative suitably trained person or even by the patient themselves.

We continue to engage with Marketing Authorisation Holders (MAHs), to address the questions raised in your letter and will take this further with regard to development of self- administration devices for patients to use at home. Many other parenteral products are currently available that allow patients to self-administer in a home setting, and with the safety aspects managed, this should certainly be explored further for Vitamin B12 injectable products.

We also note that NICE is currently developing guidance on “Vitamin B12 deficiency, including pernicious anaemia: diagnosis and management” and will make recommendations. The NICE review covers managing vitamin B12 deficiency, including clinical aspects of vitamin B12 replacement, including the dose, frequency and route of administration, and also covers the clinical aspects of self-administration compared with healthcare professional administration of parenteral vitamin B12 replacement.The NICE guidance mentioned above is expected to be completed towards the end of 2023 and its recommendations will accelerate progress in this area.

As the regulator, we want to engage with MAH’s early and facilitate any such developments, for the benefit of patients and public health.We will keep you informed of the outcome of these meetings, early in the New Year.

Yours sincerely,

Dr June Raine, DBE
Chief Executive
Medicines and Healthcare products Regulatory Agency E: Chief.Executive@mhra.gov.uk



Dr June Raine reckons she will keep Jane Hunt MP informed of the outcomes of meetings early in the New Year (and if we refer back to Jane Hunt’s email of October 2021, they were having conversations with the MAH’s prior to that date) – but that NICE Guidance recommendations at the end of 2023 will accelerate progress in this area – WHAT?????

I have spoken to MAH’s years ago – what they want is to sell their products to as many people as possible and they would be happy to do this with injectable B12. Changing things is an easy process involving form filling and as usual money changing hands, so what exactly is the hold up?

The MHRA, in their wisdom, think we need to wait yet another year on top of the nine or ten we’ll have waited, whilst their rules keeps people; exhausted, bed bound, incontinent, psychotic, depressed and confused because they refuse to cut the flimsy red tape holding this ridiculous situation together.

We don’t need nannying. The MHRA can ask other countries who allow purchase of injectable B12 OTC, for example, Canada, France, Spain how this deal works. They can also ask the sensible and progressive UK GP’s who ‘allow’ their patients to be trusted to give themselves their own B12 injections how it’s going. I’m sure the response would be, “marvellous – what’s not to like?

The situation for many people with B12 deficiency remains absolutely dire with regard to correct treatment from their doctor, both here in the UK and in the wider world. All people want is to feel well and to be treated as individuals. Vitamin B12 is a VITAMIN after all – it’s not a heavy drug, it’s water soluble and absolutely vital for life. The constant pushing of antidepressants and strong painkillers for those under treated for B12 deficiency, in place of a vitamin is at best completely and utterly incomprehensible and at worst, disgusting.

B12 as ‘medicine’

As we all know our situation lies in the game of semantics. I add text from my previous blog –  MHRA and Double standards on vitamin B12 injections below;

The MHRA state: ‘Our current advice to private clinics administering vitamin B12 injections which are not licensed medicinal products intravenously for non-medicinal purposes is that we do not regard these to be medicines and that they fall outside of the remit of the MHRA. It must be absolutely clear in the advertising of such products that they do not have a medical purpose.’

So the same B12 (hydroxocobalamin in this case), from the very same manufacturers, is at the very same time; A licensed medicinal product and also a non-medicinal product. Mad, maddening and hilarious all at the same time isn’t it?


Why don’t the MHRA use the word ‘vitamin‘ in front of B12 injections and remove words ‘medicinal product’ altogether as this is the crux of our problem, words. Just words.

We know that the MHRA have said incorrectly – that B12 given by hair salons/beauty clinics is different to the B12 given by your GP – but that’s not true.

It’s just the words they use to classify it.

The MHRA say the B12 injections fall outside their remit. So why not let all B12 injections fall outside their remit? As we already know people who are not trained medically can give B12 injections to any old Tom, Dick or Harry.

These salons/clinics can make any claim about B12 injections but can’t use the word medicine or any derivative of it. So if our pharmacists popped a sign in their windows promoting B12 injections without mentioning medicine then surely they could get away with selling us injectable B12? Something along the lines of… ‘come and buy your vitamin B12 ampoules here, save your own life because your GP isn’t allowed to.’ would be a good start!

Rest assured, I shall keep on chasing and badgering and trying to get meetings because it’s a vital issue. We should be in charge of our own healing, there is no good reason to deprive the UK or any other nation, of injectable B12 OTC.

Kindness always,
Tracey x

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  1. Amanda Rutherford

    Thank you for taking this issue forward and fighting for those who are unable to have their voices heard. I worry about my daughter as she was prem and has had long term gut issues and at 15years I still get fobbed off that her b12 is fine . I think she was born at 24weeks because I was suffering from low b12 but not low enough according to the then NICE guidelines but I had had loads of symptoms for several years before . Then a diagnosis of fibromyalgia and no real help offered had to search and self treat with B12

    • Tracey Witty

      Thank goodness you are taking your healing into your own hands Amanda, we have no alternative but to do this when the system does not work, assumes we are all the same and that test results are the oracle. Wishing you and your daughter the very best x

  2. Christine Monkhouse

    Brilliant work, Tracey! I have a meeting coming up with my MP about the uselss way that the Ombudsman and NHS Englnad have dealt with my complaints that doctors do not follow NICE guidelines. I hope the revised NICE Guidance is improved – but what’s the use if the medical profession won’t follow it?

    • Tracey Witty

      Thank you Christine and good for you I am right behind you! I was part of the Stakeholder meetings for the new Guideline and hopefully the things that were stated about the reality of being a patient with B12 deficiency will have an impact and be part of the new NICE Guidance, but we absolutely don’t need to be waiting another year for a simple act to change this situation.x

  3. Jane Read

    Thanks for all you are doing

    • Tracey Witty

      Thank you for taking the time to comment Jane x

  4. Eileen Trenchard

    Thank you so much for doing what you’re doing Tracey. As you say above, it’s madness that they say it’s a licensed medicinal product and it’s also not a medicinal product!

    • Tracey Witty

      Yes complete madness Eileen! Thank you for taking the time to comment x

  5. Ann Ling

    I was refused my injections at the beginning of the Pandemic, I challenged the decision as I had been having injections every 8 weeks for 8 years, I made a formal complaint to my surgery which wasn’t acted upon. Contacted Health Watch East Sussex, who acted on my behalf , 20 months later I was diagnosed with Colon Cancer,only through my Surgeon were my Injections for Pernicious Anaemia reinstated . The figures my Surgery work with are between 175 to 800 , totally inadequate for many of us , being 85 years old my higher figure should be at least 1200, Nice guidelines don’t help us at all.

  6. Lisa Wallser

    Thank you for your amazing work! I recently asked my GP if he would train me or my husband to self administer he said he didn’t see any problem. Also it’s time saving for GPs when we don’t have enough GPs

    • Tracey Witty

      Absolutely Lisa! Thank you for your kind words x

  7. Elaine Davis

    I am one of the lucky ones in that my GP does prescribe my B12 for me to inject at home but it was a long battle to get that. Adversely I have more recently been diagnosed with an autoimmune arthritic illness for which the prescribed treatment is a controlled drug which can have some pretty nasty side effects. Three months into this treatment I was asked if I would like to change from tablets to weekly injections as these apparently have less side effects and are considered to work better. A simple yes from me produced a prescription for injections and an appointment to show me how to do them. They come as a preloaded pen for sub cut delivery. I believe that the major problem with getting B12 available OTC is the fact that Hydroxocobalamin specifically indicates that it has to be delivered IM and that the Medical profession seem to believe we are incapable of doing IM injections.

    • hkt1850@gmail.com

      The packs of hydroxoc. from Germany specifically say that the B12 can be delivered IM, SC and IV.

  8. Ann Wright

    Excellent response Tracey I know you will press on no matter how hard

    • Tracey Witty

      Thank you for your kind words Ann! x

  9. Gordon Jones

    The previous comment “Hydroxocobalamin specifically indicates that it has to be delivered IM”

    I guess most GP’s would say that – but the packaging on the B12 I source from Germany states that it is suitable for IM & SC injection (also IV I think)
    I also found an article by a GP (in oxfordshire I think) that stated the same – nothing wrong with SC injection.

    • Hilary Thompson

      Many PA sufferers inject SC. I do now after my surgery’s 8 weekly offer which was simply not enough. I can regulate my intake depending on fluctuating symptoms. As life fluctuates, so do symptoms. The amount I inject is well suited to SC injection.

  10. Helen Brodie

    Dear Tracey,
    A big thank you to you and the rest of the team for your perseverance
    I am a 65 year old woman living bin Surrey and have been having regular B12 shots for approximately 10years. Originally I was three monthly but for the past 4 years I have had monthly through my local NHS GP Practice.
    For some time I had these in my arm but this became more and more painful until holidaying abroad in the BVI I saw a doctor who gave me the injection in my backside. He was incredibly careful and explained that a slow delivery was crucial and that the B12 should be at room temp. All that for $45 dollars.
    I had my B12 bounce and felt great again.
    Good luck
    Helen Brodie

  11. M A Leahy

    Excellent work, in Europe it’s treated as a vitamin, otc product & yet it’s been described as a medical in the UK

  12. Brian Wood

    The WEF accelerated Agenda 2030 openly targets planetary control and depopulation. This is evident across many aspects of society here and abroad. Withholding B12 is a nice little earner in peddling other big pharma drugs and of course in shortening lifespans. This is another example of disciplining the little people to obey authority.

  13. Brian Wood

    The WEF accelerated Agenda 2030 openly targets planetary control and depopulation. This is evident across many aspects of society here and abroad. Withholding B12 is a nice little earner in peddling other big pharma drugs and of course in shortening lifespans. The little people must obey authority.

  14. Michelle Josephine Cheatley


    • Isabella M Slominska

      ‘Tis the pharmaceuticals which fund the MHRA which licences the pharmaceauticals

  15. kevin mountford

    well done Tracey ,and thank you for all your hard work

  16. Ali

    I personally cannot thank you enough for your incredible work. I used to source my B12 from Germany as I couldn’t wait for the newly instructed (from gp partner) interval from b12 injection monthly to every 3months. I cannot function properly and all my once dormant symptoms, have come back with a vengeance. Germany no longer delivers to the UK so my health is declining rapidly and there is absolutely nothing anyone will do. My lovely practice nurse tried her best but her pleas fell on deaf ears.
    So, your work is appreciated more than you know. I truly hope that sense prevails.

    • monkeyweymouth

      You can still get b12 from Germany in the UK.

      • monkeyweymouth

        B12 is still available to order from Germany to the UK.

    • monkeyweymouth

      I don’t know whether you’ve seen my comment yet but B12 is still available to order from Germany to the UK.

    • monkeyweymouth

      I don’t know whether you’ve seen my comment yet but you can still source b12 from Germany to the UK.

  17. Michaela Harrison

    Thank you so much for pursuing this important issue. During the first stages of the pandemic, I was forced to purchase B12 powder and saline from Germany in order to function (as my gp simply refused my request to self administer but also refused to see me!?) so I taught myself to inject correctly and changed my gp! During 2021, there was a sudden inability from the German supplier to send the correct saline and found a Uk source… but hey, I was allergic to it? Who knew you could have an allergy to saline? Any how, I now get my prescription and my new surgery are happy for me to self administer. So as long as I have a supply, I can feel human again x
    My only hope is that other people are as lucky as me and find a way that works for them also Xx

  18. Isabella M Slominska

    MHRA and Injectable Vitamin B12

    The REAL problem seems very clear to me: the “great and the good” at MHRA do not know what vitamin B12 is, let alone the devastation caused by B12 deficiency.

    They are ignorant- that’s all. Just simple pen-pushers. They are not educated- they have no idea of medical physiology/ biology. We cannot educate them- they are fossilised and do not want to learn.

    Perhaps we should try another angle: petition and lobby for the ABOLITION of MHRA on the basis of the loss,damage and injury they are causing to untold patients’ suffering, through their NEGLIGENCE. Their ignorance.

    The MHRA is a liability to the health of our nation. Liability to patients.

    Not only do they not know/care about the effects of blocking access to an essential-to-life ..vitamins. they also do it to thyronine, sold as Liothyronine- the active thyroid hormone which controls metabolism. Meanwhile they licence drugs which seriously debilitate or destroy people. Think antidepressants.

    You cannot make it up. Hallo MHRA- you are dead without metabolism: you need active thyroid hormone and it’s partner vitamin B12.

    Other countries know this, that is why you can buy high-quality Liothyronine and vitamin B12 injections OTC. They have medical doctors and regulators who are not ignorant- they understand basics.

    Try and find a GP or endocrinologist who understands that B12 and thyronine are ESSENTIAL to life and that thyronine or B12 does not kill people: together, they sustain life. This seems to be such an advanced concept to MHRA …….or newly- qualified quacks- they really and truly, do not understand the basics. Whereas, experienced, knowledgeable medics are harried and hounded into retirement.

    We need to do things differently:

    Let us lobby for the abolition of the MHRA and the deregulation of all injectable vitamins ; deregulation of liothyronine and suppliers and break the cartels which are holding our lives/our health to ransom.

    It is all about money and we could be saving the NHS £billions, as well as freeing countless hundreds and thousands of patients from disability, pain and misery.

    Perhaps the Government needs to think afresh- We should crowdfund for the abolition of MHRA and de-regulation of vitamins and pharmaceutical suppliers.

    Thank You

  19. Isabella M Slominska

    Dear Tracey

    Thank you for your continued fight for all of us. I so admire your patience when dealing with those who refuse to listen. All power to your elbow!

    with lovex

  20. monkeyweymouth

    Thank you for continuing to fight. Clearly they’re in no hurry if they’re looking at it the end of 2023. Very disappointing.

  21. monkeyweymouth

    Would trying to change the UK license of b12 to subcutaneous make it more likely that’ll be made OTC?

  22. lesley legassick

    Excellent, comprehensive, clear and informative update summing up the current situation.

  23. David Goodland

    I’m a full time carer for my husband with lymphoma. I need to be on top of things, especially my own mental health. I’m pretty good at caring. The surgery stopped my Cobalamin injections during Covid. I asked if they would put me back on after Lockdown finished. The answer was no. I said I couldn’t afford to be below par and pleaded with them to give me the injections. In Spain I bought b12 over the counter and now self inject monthly. It costs 3 euros for 5 phials. I feel fine. I can cope. Without b12 injections I’m a mess. They say it’s psychological. I say so what? It works! I’m looking after my husband. They put that at risk. I’m furious. What’s their game?

  24. Janet Crosley

    Totally unacceptable situation.
    Thankyou very much Tracey,for your hard work and constancy.
    You are a diamond.xx

  25. Sarah

    Hi Tracey,

    Is the petition now closed?

    A friend wanted to sign it and couldn’t.

    • Tracey Witty

      It is now closed Sarah, the petition is with the government and the MHRA are supposedly dealing with it. We are now having to work through these channels.
      Best wishes Tracey

  26. Trudi

    Thank goodness we have you fighting
    My own MP is (as the saying goes) as useless as a chocolate teapot and permanently sits on the fence with anything that isn’t to his benefit or will stir his calm waters.

    My gp, sympathetic as she is, hide behind surgery protocol.
    I/we need to take our health and lifestyle into our own hands soon!

    • Tracey Witty

      Thank you for your comment Trudy, I agree with you. Many conditions prompt a GP to ask the patient what they want to do and give them a choice of medications, not so with B12 deficiency. It’s madness.

      Very best wishes

  27. Nia

    Thank you Tracey for all the continued dedicated hard work your doing let’s hope this year you see progress from them.

    • Tracey Witty

      Thank you Nia, lets hope so!

  28. Mrssomerset

    I am baffled by the delays, perhaps because it is not manufactured in the UK?
    I can walk into( well I can’t because I am now in a wheelchair) any pharmacy in France, Germany, Italy and buy as many boxes of 10 ampules as I want without prescription, around £10 for a box of 10 ampules at 1mg/ 1ml hydroxycobalamin.
    Additionally I can walk into any UK pharmacy, supermarket, amazon.co.uk and but rediculously high strength B12 tablets, as many as I want, no restrictions at all.
    So the issue cannot be the fact it is B12, as in the UK you can but B12 anywhere, as a tablet .
    The tablets are of no use to people with PA, but we can inject it, ourselves.
    I read that in the USA they even inject it subcutaneously, using autoinjectors like for insulin.
    I have been injecting myself for 10 years now, a quick lesson from the Nurse doing the loading dose at the surgery, and now I do it myself. I have to buy the syringes, needles, alcohol wipes myself, but I don’t care, there are medical supply companies that sell me boxes of 100 at reasonable price, delivered.
    My issue is:
    1: loafing dose, my GP just stopped it, without telling me or the haemotologist.
    2: B12 supply , my GP just stopped my B12 prescription, again didn’t tell me, didn’t tell my haemotologist, and when I chased him on it, he said ” you must be full by now”, I got support from my haemotologist and the PA society that told him he was an idiot and to give me my B12, now.
    3: timing, the study, that nice relies on, was a small sample study focusing on only red blood cells, back in the 70s. It is factually incorrect. Before that study patients reciev s B12 as and when they needed it. If I was a person now that didn’t need B12 supplément to live( not die), I could buy thousands of B12 pills, no questions asked, no restrictions at all, but if I am going to die without it, I am limited to one dose every 3 months, it’s insane!
    4: I would dearly love the name of the condition to be changed, there are far too many doctors, GPA, who didn’t pay attention or were not trained, and insist that Pernicious anemia only affects the red blood cells, and my GP, did I mention he was an idiot, actually tested my B12 after my 2 week loading dose, and then told me I was fine now????? If we could call it what it is, autoimmune chronic B12 deficiency, perhaps gps would bother to look it up when they don’t know, and not just assume that it’s just anemia and you should eat more meat( yep my hp said that too).

    I am do glad for you and your team and everything they do to drive home to the powers that be, that this is not ” rare” , it is not something that goes away, and that access to meds ( B12 ampules) as needed is the least they can do.
    They don’t make diabetics come in to the surgery once every 3 months for their insulin, they inject at home, as needed, and insulin can kill you, B12 can’t.

    • Tracey Witty

      Dear Mrs Somerset,

      Your story shocking. The stoppage of treatment is appalling and all to common. It’s a wonder that anyone can keep themselves functioning without self treating. It’s disheartening that we are now 9 years in since I started petitioning for this simple act that would completely transform many peoples lives if it could be allowed.

      My team consists of me, with huge support and design skills from Damian. Thank you for your kind words!


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