u8myufo
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I heard rumour, govs secretly passing law.
- Thread starter yodadude
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Ninjaassasin1983
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its what I do i'm good at digging I shall report back if i find anything further I can see us lot having to protest in 3 years u know that
Fleabag
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The flavour issue is a pointless one from the outset - I have 29 bottles of extra strength food flavouring suitable for use in e-juice (and e-juice is basically food flavouring plus nic & dilutant anyway).
They can't stop us flavouring our own juice (though I would rather not have to add it to tobacco or menthol flavour)
oh, unless food flavourings are going to be banned now!
They can't stop us flavouring our own juice (though I would rather not have to add it to tobacco or menthol flavour)
oh, unless food flavourings are going to be banned now!
Ninjaassasin1983
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Electronic cigarettes (eCigarettes) are set to be regulated as medicinal products under the Tobacco Products Directive when it is transcribed into UK law, which is expected to be in 2016. Spectrum Regulatory Solutions can help manufacturers to ensure that their electronic cigarette products will meet all UK (and, in due course, other European Union countries) regulatory requirements, especially regarding quality and safety. Once the legislation is enacted, manufacturers of eCigarettes will require the following before they can market (or continue to market) their products in the UK:
• A Marketing Authorisation from the MHRA to sell the nicotine component as a medicine. A (Complex Abridged) Marketing Authorisation Application (MAA) must be submitted to obtain this authorisation
• Registration as a Class IIa medical device for eCigarettes
• CE marking for the electronic components of eCigarettes.
Electronic Cigarettes to be Regulated as Medicines
In line with the draft Tobacco Directive, the Commission on Human Medicines, the advisory body of the MHRA, has judged that eCigarettes are largely used to reduce the harm associated with tobacco smoking and should therefore be classed as a medicinal product. The UK government has therefore announced that the MHRA will regulate eCigarettes and other Nicotine Containing Products (NCPs) as medicinal products. The primary purpose of this regulatory change is to ensure the quality and safety of NCPs. As a result of these changes, companies in the UK are being encouraged to make early applications to the MHRA for medicines licenses for nicotine containing products, especially eCigarettes.
Compliance Required By 2016
It is expected that the EU Tobacco Directive will be adopted in 2014, and will be transcribed into UK law by 2016. However, in line with government policy, the MHRA is already accepting MAAs for companies who wish to ensure early compliance with the up-coming law, and to ensure uninterrupted supply of eCigarettes in the UK market. Companies submitting an early MAA are likely to have a competitive advantage when the Tobacco Directive becomes UK law.
Start Early
In order to submit a MAA eCigarette manufacturers will be required to first conduct a series of analytical studies to demonstrate that the components of the eCigarette vapour are below permissible safety thresholds. In addition, they will need to conduct a Phase I clinical study in healthy volunteer smokers. This study, which typically involves about 25 individuals, is required to show that the amount of nicotine absorbed into the bloodstream from the eCigarette is bioequivalent to that from the Nicorette Inhaler. This clinical study is required to support the medicinal claim for the product (e.g. aids smoking cessation and/or reduces harm). Companies are advised to seek Scientific Advice from the MHRA before starting a development programme to ensure that regulatory expectations are met.
In addition, if a CE mark for the electronic component of the eCigarette has not already been obtained, the studies required in support of an application to a Notified Body for the CE mark will need to be completed.
“Spectrum can help our clients conduct these studies and prepare the regulatory documentation as well as help prepare the MAA and Technical File, if required” said Dr Angela Gisby, Managing Director. Following submission to the MHRA, a Complex Abridged MAA should be approved within 100 days (plus any days during the ‘clock stop’ when the Applicant is responding to regulatory questions). The time from an initial development programme for the eCigarette to final MHRA / Notified Body approval could be 12 months depending on if there are any safety concerns associated with the product.
As well as competitive advantage, an additional advantage of seeking an early Marketing Authorisation from the MHRA is the possibility of benefiting from some flexibility in the application of the regulations. Currently MHRA is offering free scientific advice to early adopters.
• A Marketing Authorisation from the MHRA to sell the nicotine component as a medicine. A (Complex Abridged) Marketing Authorisation Application (MAA) must be submitted to obtain this authorisation
• Registration as a Class IIa medical device for eCigarettes
• CE marking for the electronic components of eCigarettes.
Electronic Cigarettes to be Regulated as Medicines
In line with the draft Tobacco Directive, the Commission on Human Medicines, the advisory body of the MHRA, has judged that eCigarettes are largely used to reduce the harm associated with tobacco smoking and should therefore be classed as a medicinal product. The UK government has therefore announced that the MHRA will regulate eCigarettes and other Nicotine Containing Products (NCPs) as medicinal products. The primary purpose of this regulatory change is to ensure the quality and safety of NCPs. As a result of these changes, companies in the UK are being encouraged to make early applications to the MHRA for medicines licenses for nicotine containing products, especially eCigarettes.
Compliance Required By 2016
It is expected that the EU Tobacco Directive will be adopted in 2014, and will be transcribed into UK law by 2016. However, in line with government policy, the MHRA is already accepting MAAs for companies who wish to ensure early compliance with the up-coming law, and to ensure uninterrupted supply of eCigarettes in the UK market. Companies submitting an early MAA are likely to have a competitive advantage when the Tobacco Directive becomes UK law.
Start Early
In order to submit a MAA eCigarette manufacturers will be required to first conduct a series of analytical studies to demonstrate that the components of the eCigarette vapour are below permissible safety thresholds. In addition, they will need to conduct a Phase I clinical study in healthy volunteer smokers. This study, which typically involves about 25 individuals, is required to show that the amount of nicotine absorbed into the bloodstream from the eCigarette is bioequivalent to that from the Nicorette Inhaler. This clinical study is required to support the medicinal claim for the product (e.g. aids smoking cessation and/or reduces harm). Companies are advised to seek Scientific Advice from the MHRA before starting a development programme to ensure that regulatory expectations are met.
In addition, if a CE mark for the electronic component of the eCigarette has not already been obtained, the studies required in support of an application to a Notified Body for the CE mark will need to be completed.
“Spectrum can help our clients conduct these studies and prepare the regulatory documentation as well as help prepare the MAA and Technical File, if required” said Dr Angela Gisby, Managing Director. Following submission to the MHRA, a Complex Abridged MAA should be approved within 100 days (plus any days during the ‘clock stop’ when the Applicant is responding to regulatory questions). The time from an initial development programme for the eCigarette to final MHRA / Notified Body approval could be 12 months depending on if there are any safety concerns associated with the product.
As well as competitive advantage, an additional advantage of seeking an early Marketing Authorisation from the MHRA is the possibility of benefiting from some flexibility in the application of the regulations. Currently MHRA is offering free scientific advice to early adopters.
Ninjaassasin1983
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gonna need a licence to sell nicotine as a medicine which takes 100 days to approve at the least
Ninjaassasin1983
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basically they're just trying to let the big cig companies move into ecigs so they can corner the market and tax the fuck out of us
Ninjaassasin1983
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sorry for the profanity guys but im kinda pissed off at this
EthelKing
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I don't want to add fuel to the fire, or indeed piss on anyone's fire, but I was at the London ecigarette summit, and it was as plain as the nose on your face that the UK government ARE going ahead with their plans to medically regulate e-cigarettes. There was no mention of diluted measures in respect of the TPD, or that the government will be looking at two different regulations - one for medically prescribed e-cigs, and another for the recreational market. E-juices WILL be affected, and if the plans go ahead the selling non-licenced fluids will be a criminal offence. The same will apply to devices. Its as simple as that.
On the brighter side, the experts were largely in agreement that by 2016 the number of vapers will be a lot lot more today and trying to enforce the new laws and trying to control internet sales, justify closing down businesses and taking action against individuals would be a very big task, and likely to be a bit of a politically unsafe move given the number of potential job losses and everything that goes with that.
I really do believe that those making the policies haven't got a fecking clue what is going on in the marketplace and that there are many existing small companies making quality products, who will either dissapear or be bought by the larger companies in the event of medical regulation becoming a reality, as they will never be able to afford the costs of the licences they would require to carry on trading, not to mention the huge investment in bespoke premises etc. which would be needed to meet the requirements of medicine production.
I hope that any attempt at medical regulation in the Umited Kingdom will be challenged in court and stopped, as it has been in other European countries.
But make no mistake, regulation in some form WILL happen, and there will be casualties as a result. As vaping continues to grow, there will be more and more shit pedlars and knowledgeless opportunists selling all manner of crap to the unsuspecting public.
I hope to God that I completely misunderstood what the MHRA said, but I am 99% sure that I didn't. One thing I am certain of is that there will be a very, very healthy black market in vaping supplies in the not too distant future if common sense doesn't start to play a part, but when has government ever applied common sense?
On the brighter side, the experts were largely in agreement that by 2016 the number of vapers will be a lot lot more today and trying to enforce the new laws and trying to control internet sales, justify closing down businesses and taking action against individuals would be a very big task, and likely to be a bit of a politically unsafe move given the number of potential job losses and everything that goes with that.
I really do believe that those making the policies haven't got a fecking clue what is going on in the marketplace and that there are many existing small companies making quality products, who will either dissapear or be bought by the larger companies in the event of medical regulation becoming a reality, as they will never be able to afford the costs of the licences they would require to carry on trading, not to mention the huge investment in bespoke premises etc. which would be needed to meet the requirements of medicine production.
I hope that any attempt at medical regulation in the Umited Kingdom will be challenged in court and stopped, as it has been in other European countries.
But make no mistake, regulation in some form WILL happen, and there will be casualties as a result. As vaping continues to grow, there will be more and more shit pedlars and knowledgeless opportunists selling all manner of crap to the unsuspecting public.
I hope to God that I completely misunderstood what the MHRA said, but I am 99% sure that I didn't. One thing I am certain of is that there will be a very, very healthy black market in vaping supplies in the not too distant future if common sense doesn't start to play a part, but when has government ever applied common sense?
K
KulrMeStoopid
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Even if the UK gov did that, ECITA will go after them or TW and I think those two forces, no matter how divided they are, will prevail.
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