Is it completely legal to import B12 ampoules from abroad if you don't have a PA diagnosis?

[Violette]

Strictly for personal use.

Trying to figure it out but getting a bit confused...

[wedgewood]

Nothing illegal about importing B12 ampoules for any reason at all .

[helvella]

I think this covers the issue of importing prescription-only medicines for personal use:

Human Medicines Regulations 2012.

PART 3 Manufacturing and wholesale dealing

Grant etc of licences

Manufacturing of medicinal products

17.—(1) A person may not except in accordance with a licence (a “manufacturer’s licence”)—

(a)manufacture, assemble or import from a state other than an EEA State any medicinal product; or

(b)possess a medicinal product for the purpose of any activity in sub-paragraph (a).

(2) Paragraph (1) is subject to paragraphs (3) to (5).

(3) Paragraph (1) applies in relation to an investigational medicinal product only—

(a)if the product has a marketing authorisation, Article 126a authorisation, certificate of registration or traditional herbal registration; and

(b)to the extent that the manufacture or assembly of the product is in accordance with the terms and conditions of that authorisation, certificate or registration.

(4) In paragraph (3), “marketing authorisation” means—

(a)a marketing authorisation issued by a competent authority in accordance with the 2001 Directive; or

(b)an EU marketing authorisation.

(5) Paragraph (1) does not apply to a person who, in connection with the importation of a medicinal product from a state other than an EEA State—

(a)provides facilities solely for transporting the product; or

(b)acting as an import agent, imports the medicinal product solely to the order of another person who holds a manufacturer’s licence authorising the importation of the product.

(6) Paragraph (1) does not apply to a person who imports a medicinal product for administration to himself or herself or to any other person who is a member of that person’s household.

legislation.gov.uk/uksi/201...

[fbirder]

I asked the MHRA about this in 2019. This was their reply...

Thank you for your email.

• 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:

gov.uk/check-medicines-online

• 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:

gov.uk/guidance/controlled-...

• 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).

[helvella in reply to fbirder]

What a lot of silliness in that reply. (No complaints you have quoted it!)

First, why restrict to the EU? Especially when brexit was already approaching completion? And "registered with us" is surely history?

Second, how can anyone such as an HMRC/Border Force person know what is a three month supply? And just what is the legal basis for such a limit?

Third, they haven't thought this through. Imagine having a letter or prescription from a patient's doctor written in Japanese? Thai? Sinhalese? Russian? There is nothing I can imagine which forces your doctor to be English-speaking/writing! Why, even Welsh would likely be a challenge to most of HMRC. And without requiring use of English, it might as well be last week's newspaper.

[Violette]

Thank you all so much, just wanted to make sure x

[Sgboyd]

You can still be deficient without having PA and this is something you should work with your doctor on. There's no need to order abroad at that point as ant prescription will be covered by insurance plans here.