A couple of weeks ago I wrote to the MHRA regarding the importation of B12 for injections from Germany. Their full response is below. Here is a summary -
Check that any online pharmacy displays the EU Pharmacy logo - shown above - I have checked versandapo and Bodfeld - both carry the logo.
You are allowed to import medicines for personal use - you and your immediate family or household.
You are not allowed to pass medicines on to anybody else - selling or giving.
Three months supply is an acceptable amount for personal use. Any more and HMRC might take an interest.
The above doesn't apply to controlled drugs. Note that gabapentin and pregabalin have recently been classified as controlled substances. B12 is not.
•If you are considering purchasing a medicine over the internet then you should look for sites that display the EU pharmacy logo – as this means a site is registered with us:
•Buying medicines through unregulated sources can put you at serious risk as you have no idea what you are getting and how it will affect you. If you require treatment for a medical condition then we recommend you speak to a GP or your pharmacist. Prescription and pharmacy medicines should always be obtained from a legitimate high street or online pharmacy
•There is no requirement for a member of the public to notify us of the importation of medicines for personal use and the legislation does not restrict such importation. Consequently, we do not issue any form of licence, certificate or authorisation to aid personal importation. We consider personal use to involve the use of the products by yourself or your immediate family or household; under such importation an individual must not sell or supply imported medicines onward as this would be considered placing the product onto the market.
•Up to a 3 month supply of a medicine is considered to be an acceptable quantity for personal use, HM Revenue and Customs can prevent importation if large quantities are being imported and/or they have suspicions that the product is not being imported for personal use. There is more information on the HM Revenue and Customs website at the link below: gov.uk/government/organisat...
•Individuals are advised to investigate whether the product(s) to be imported would be categorised as controlled substances in the UK. Controlled drugs are regulated by the Home Office under the Misuse of Drugs Act, and can require a licence to allow their entry into the UK. Further information can be found at the link below:
•Anyone posting packages containing medicines are advised to include a copy of the prescription and/or a letter from the patient’s doctor explaining why the product(s) are required; the package should be clearly labelled on the outside stating the contents of the package and that the products are for personal use. Medicines should be kept in their original packaging and should be transported in accordance with storage conditions specified by the Manufacturer (this not only helps identify the medicines, but also helps ensure the product’s stability).
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fbirder
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Maybe I've missed something but, to me, and probably others, 3-months supply re B12 ampoules is a significantly limited amount, especially when considering the delivery charge.
Also, those of us who self-inject, generally do so without a prescription
I'm a bit concerned ... (or just dense ... )
Could you suggest how to obtain 100 ampoules B12 injection, please, or will we still be able to order 100 as we have been doing, do you think?
You can order 100 ampules (10 x10 packs ) from versandapo.de
Search for Rotexmedica VitaminB12 Depot ( this indicates that it is Hydroxocobalamin, which is what the NHS uses ) or you can go straight to the item if you use the German Pharmaceutical reference number called the PZN which you can find on all Pharmaceutical items . For a pack of 100
03862305 . For a pack of 10 the number is 03862297
You may need a translation app as this site is in German , or use Google Chrome . I think it’s best if you register with them .
The three months supply seems to me totally arbitrary. Seems more of an indication of the level they might question.
First, how do they assess three months supply? At typical dosing from NHS treatment, that could be one ampoule, possibly up to three. (There might be exceptions, such as during loading doses, and the odd person who gets more frequent injections.)
Second, there is absolutely NOTHING in the legislation (which I quoted here recently) that states or implies a quantity limit.
Third, even if you order more than they deem three months supply, I don't see any automatic right to impound the product. As I see it, they might be suspicious, they might ask questions, but they have no actual basis to refuse it.
Fourth, they would have to know how many in your household need B12 injections! If there is a hereditary component, it could affect several people in a single household.
Certainly, if you order truly vast quantities, sufficient to genuinely provoke suspicion of selling or otherwise passing on, yes, they can act.
(The same questions have been asked regarding thyroid medicine. For liothyronine, doses might vary from 2.5 to 150 micrograms a day. Very difficult to assess.)
I am going to assume that, if a Border Force officer should happen to open the package with 100 vials in, they will see the box labelled 'Vitamin B12' in big letters and not bother any further. If they do ask me then I shall say that I need to inject every day - so that three month's supply is about 90 ampoules.
Remember, what they are looking for are people trying to make a commercial profit and evading taxes, duty, and licensing laws. A hundred vials of a vitamin really isn't going to set off any alarms.
These aren't new rules. And they aren't laws. The laws are regarding the selling on off imported medicine. If HMRC should think that 100 ampoules is a lot then they will be looking for evidence that you are selling it on for a huge profit. But they will check with DHL, Versandapo, etc. and find that you place an order once every year or two - and lose interest.
Personally, I shall continue to order 100 ampoules once a year and not worry about it in the slightest.
The Nice guidelines are for NHS prescriptions and based on cost saving re hydroxocobalamin as it was costed in the 1980's.
There is ample clinical evidence supporting more frequent injections and some people need 1mg every day.
Therefore 100 ampoules at a time is a reasonable import. HMRC have been allowing people to import 100 ampoules at a time for years so there is good precedent.
No prescription is required for b12 in Germany so that bit of standard fluff in the MHRA answer is irrelevant. The 1968 medicines act prescription only requirements for medications on injectable forms only apply to UK pharmacies and prescribers.
Private individuals are not affected if it is for personal or household use.
If the German government decides to put restrictions in on personal import orders to the UK: That is entirely on them and; a rather spiteful tactic to generate pressure.
Leaving the EU makes no difference concerning the personal importation of medicines not subject to control by national or international laws.
Just as we can import b12 from Australia and some far eastern countries now despite not being in the EU or some Schengen convention on medicines with them.
On the basis that we do not know why there seems to have been a change, to say "a rather spiteful tactic to generate pressure" seems somewhat of a leap to a conclusion. Not denying the possibility, but not assuming it either.
I don't think I've seen "ample clinical evidence supporting more frequent injections and some people need 1mg every day". I've seen ample anecdotal evidence. But the BCSH say "although there is little evidence that more frequent dosing is harmful, specific objective studies demonstrating clinical benefit are absent"
Hi fbirder, do these rules hold for when or if we leave the EU with or without a "deal" Also recently there have been posts about German companies requiring a prescription for B12, which is still worrying. Any answers on that?
The rules apply regardless. But in a brexit situation there will be additional issues. Such as being required to pay VAT on all imported items and, it appears, no £15 allowance. Which in turn implies a customs clearance charge on every package (currently Royal Mail - £8, others - more).
However, at present, we can also import medicines from the EU which require prescription in the dispensing country - on presentation of a UK prescription. That will (I am sure) not continue after any sort of brexit.
Well, no-deal is looking unlikely. However, the MHRA advice is the same regardless of which country you import from (see helvella 's very useful posts on the topic).
The talk about German companies requiring a prescription is looking more and more like the excuses used by one person in one company to try to explain their self-imposed quota on the amount of B12 sent to the UK. That company, as well as at least two others have delivered B12 ampoules to me since that 'announcement'.
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