Letter from the Danish Medicines Agency

[bjarkekr]

Hi again,

I got my second answer from the Danish Medicines Agency and it seems they have classified e-cigs as a medical device no matter what...

They refer to §2 from "lægemiddelloven" (the law of medical suplies??). Here is a link to that:
https://www.retsinformation.dk/Forms/R0710.aspx?id=10187 (in danish)
If you look at that paragraf i doesnt make much sense. But the same paragraf for the law from 1995 (which is outdated), makes more sense.
https://www.retsinformation.dk/Forms/R0710.aspx?id=46864 (in danish)

If we look at the newest law again, then §4 is about the same as §2 in the old law.


Well to make it easier to undestand.. It seems that the Danish Medicines Agency can just clasify something as a medicine if its difficult to clasify it as anything else. And thereby it seems its ilegal, because it hasnt been aproved.

Tell me if im wrong.

 

[bjarkekr]

I just had a conversation with one of the people from the danish medicines agancy, and it turns out that nikotine is classified as a medicine, and since e-cigs contains pure nikotine the E-cigs is classified as a medicine. And as a medine it HAS to be aproved before it is legal to sell or buy.

 

[Denni]

Hi again,

I got my second answer from the Danish Medicines Agency and it seems they have classified e-cigs as a medical device no matter what...

They refer to §2 from "lægemiddelloven" (the law of medical suplies??). Here is a link to that:
https://www.retsinformation.dk/Forms/R0710.aspx?id=10187 (in danish)
If you look at that paragraf i doesnt make much sense. But the same paragraf for the law from 1995 (which is outdated), makes more sense.
https://www.retsinformation.dk/Forms/R0710.aspx?id=46864 (in danish)

If we look at the newest law again, then §4 is about the same as §2 in the old law.


Well to make it easier to undestand.. It seems that the Danish Medicines Agency can just clasify something as a medicine if its difficult to clasify it as anything else. And thereby it seems its ilegal, because it hasnt been aproved.

Tell me if im wrong.

That is how I understand the paragraph in the old law. So perhaps it would have been better not to draw attention to e-cig (cartridges)

The second paragraph of the new law makes no sense in this repect, it just concerns regulation, not what comprises a medicine:

Regler om lægemidlers kvalitet fastsættes af Sundhedsstyrelsen i form af en farmakope eller lignende

I think it's time to call in the lawyers

BTW, it's important that sellers show the initiative when it comes to quality testing (compliance with yet-to-be-established regulation) but they can't pre-empt the government agencies. E-cigs can still be banned at their discretion

 

[Grumpysanta]

Just a note about Denmark that may help. It is worth remembering that Denmark opted out of the EU and so in this instance are an independant country, also, from when I was last there - there were no restrictions in place with regard to smoking, mainly because the Royal Family in Denmark smoke.

 

[clavit]

I don't know when you were in Denmark Santa, but as far as i know, Denmark is indeed an EU-member.
Also, we do have laws that regulate smoking in public.
The Danish Medicines Agency has issued a press release today, in effect banning the sale of e-cigs from Danish shops.
The press release can be found here:
http://www.dkma.dk/1024/visUKLSArtikel.asp?artikelID=14250
We are still allowed to buy e-cigs from other EU countries, as long as it is for personal use!

 

[bjarkekr]

Just a note about Denmark that may help. It is worth remembering that Denmark opted out of the EU and so in this instance are an independant country, also, from when I was last there - there were no restrictions in place with regard to smoking, mainly because the Royal Family in Denmark smoke.

Im sorry, but that was the funniest post I have read in a long time.. Denmark has allways been part of EU, even back when it wasnt called EU yet. We have voted no to the euro, which is the currency. But we are indeed part of the union.

Thanks to clavit for posting the press release. Its nice that we can at least buy for personal use in other countries.

 

[clavit]

Its nice that we can at least buy for personal use in other countries.

That's how i see it! As long as the product is legal in the EU-country the shop is based in, there is no law that can prohibit Danish citizens from purchasing the products for personal use.
Also, the e-cigs themselves are not illegal in Denmark. Theoretically, we could all sell e-cigs with no-nic cartridges, and get away with it We could then leave it up to the end-user to buy e-liquid from UK-based sites.

 

[Grumpysanta]

Thanks for the clarification, I genuinly thought that Denmark had opted out of the EU completely. Sorry for the mistake, at least it made someone laugh. One thing for sure though, the freindliest people I have ever met were all in Denmark.

 

[bjarkekr]

Thanks for the clarification, I genuinly thought that Denmark had opted out of the EU completely. Sorry for the mistake, at least it made someone laugh. One thing for sure though, the freindliest people I have ever met were all in Denmark.

Hehe.. its quite allright.. We can all make mistakes