Just some key points highlighted for discussion and and clarification of the implications of the proposed legislation for those without the time to go through the complete document(s).
Full document is here : http://www.mhra.gov.uk/home/idcplg?...065618&RevisionSelectionMethod=LatestReleased
Note: NCP referred to throughout can be considered to be e-liquid or cartridges containing e-liquid for our purposes.
13. There are a number of products (including nicotine containing electronic cigarettes,
topical gels and oral forms) purporting to contain nicotine, that are widely and easily
available but are not licensed medicines. Currently, any NCP that claims or implies that it
can assist in the cessation of smoking is deemed by the MHRA to be a medicinal product.
However, this approach has allowed NCPs that do not make similar claims to be used and
sold as substitutes and partial substitutes for smoking.
16. From the very limited data available (summarised in Annex A ), NCPs cannot guarantee
quality the release of nicotine from the same NCP over time can vary with reduction over ;
time indicating instability throughout its shelf life and the amount of nicotine/product might
not be the same from batch to batch. In terms of efficacy there can be widely differing
amounts of nicotine from the same format (i.e. patch, orally, via an electronic cigarette) with
one form delivering what could be an effective therapeutic dose, another a “placebo” dose.
With regards to safety, toxic elements may be included and unexpectedly high doses of
nicotine could produce adverse effects, particularly in some vulnerable patient groups such
as those with cardiovascular disease. We know from work done by the Food and Drug
Administration (FDA) in the United States that laboratory analyses of e-cigarette samples
were found to contain carcinogens and toxic chemicals, against which general product safety
legislation could not protect. Bringing all current unlicensed NCPs into regulation would
eliminate these issues and ensure that smokers had products of the requisite quality,
efficacy and safety to eliminate or reduce the harm from smoking.
17. If a decision is made to regulate unlicensed NCPs, manufacturers of unlicensed NCPs
wishing to continue their presence on the market would have to go through the process of
licensing those products. This would bring into regulation a range of products, such as
electronic cigarettes containing nicotine and nicotine gels, which have not previously been
caught by regulation. There would also be a challenge to ensure that we capture within
regulation nicotine containing products without impacting on tobacco products. This,
however, needs to be weighed against the (unknown) risk to public health of the continuing
availability of products which have not been assessed for safety, quality and efficacy, and do
not have the same safeguards in place i.e. the obligations of MA holders.
18. In order to ensure there is no risk to public health from unlicensed products on the
market that have not been assessed for safety, quality and efficacy and in the light of the
developing extent of their use and familiarity we are consulting to elicit views on whether and
how to bring all products containing nicotine into regulation.
What is the problem under consideration? Why is government intervention necessary?
There are a number of products purporting to contain nicotine (including some electronic cigarettes and
topical gels), that are widely available but are not licensed medicines and have therefore not been tested for safety, quality and efficacy. In addition, following advice from the Commission on Human
Medicines (CHM), an extended indication to include a ‘harm reduction’ element for nicotine replacement
therapy (NRT) products has been approved. The extension of the indication to include harm reduction
marks a major shift in approach in medicines regulation. NRT has to date not been licensed for harm
reduction and the decision to do so raises the question of the regulation of other nicotine containing
products (NCPs). The MHRA is consulting on whether to bring all these products within medicines
legislation.
What are the policy objectives and the intended effects?
One option being consulted upon is to bring unlicensed NCPs into medicines regulation, thus protecting
public health from products that have not been assessed for safety, quality and efficacy. The effect of the proposal would be that all unlicensed NCPs will either be removed from the market or manufacturers will have to license them as medicines by a specific date.
Key Assumptions/Sensitivities/Risks
It is assumed that 50% of NCPs will become licensed. A potential risk is the sale of the NCPs from foreign market advertised on the internet as there are virtually no controls on importation for personal use and so it is not possible to prevent products advertised on non-UK websites being sold and supplied to the UK, unless we had a Banning Order in place.
Industry
12. Manufacturers of unlicensed NCPs will need to go through the process of licensing their
products as medicines or make the decision to withdraw their products from the market. If
manufacturers choose to apply for a marketing authorisation (MA) the applications would be
regarded as abridged complex applications and currently attract a fee of £28,780. We
understand there are around 24 manufacturers that produce unlicensed NCPs that are
distributed by around 80 distributors in the UK. We have estimated that there are around 100
unlicensed NCPs that are distributed in the UK and we have assumed that 50% of
22 manufacturers will go through the process of licensing their products, resulting in the licensing
of about 50 products. We would therefore expect to receive 50 applications for MAs at an
estimated one-off cost to industry of £1.439 million. This includes the manufacturer’s licence,
which currently attracts a fee of £3027.
14. We have assumed that 50% of the 24 manufacturers would not choose to go through the process of licensing their products and would therefore choose to withdraw their products from the market in the UK. Therefore around 12 manufacturers would lose sales in the UK and this has yet to be estimated. They do, however, have the option of licensing their products rather than lose their sales and the aim of the DH strategy is to increase the use of substitute nicotine products, which will result in greater profits for those who choose to manufacture these products.
Full document is here : http://www.mhra.gov.uk/home/idcplg?...065618&RevisionSelectionMethod=LatestReleased
Note: NCP referred to throughout can be considered to be e-liquid or cartridges containing e-liquid for our purposes.
13. There are a number of products (including nicotine containing electronic cigarettes,
topical gels and oral forms) purporting to contain nicotine, that are widely and easily
available but are not licensed medicines. Currently, any NCP that claims or implies that it
can assist in the cessation of smoking is deemed by the MHRA to be a medicinal product.
However, this approach has allowed NCPs that do not make similar claims to be used and
sold as substitutes and partial substitutes for smoking.
16. From the very limited data available (summarised in Annex A ), NCPs cannot guarantee
quality the release of nicotine from the same NCP over time can vary with reduction over ;
time indicating instability throughout its shelf life and the amount of nicotine/product might
not be the same from batch to batch. In terms of efficacy there can be widely differing
amounts of nicotine from the same format (i.e. patch, orally, via an electronic cigarette) with
one form delivering what could be an effective therapeutic dose, another a “placebo” dose.
With regards to safety, toxic elements may be included and unexpectedly high doses of
nicotine could produce adverse effects, particularly in some vulnerable patient groups such
as those with cardiovascular disease. We know from work done by the Food and Drug
Administration (FDA) in the United States that laboratory analyses of e-cigarette samples
were found to contain carcinogens and toxic chemicals, against which general product safety
legislation could not protect. Bringing all current unlicensed NCPs into regulation would
eliminate these issues and ensure that smokers had products of the requisite quality,
efficacy and safety to eliminate or reduce the harm from smoking.
17. If a decision is made to regulate unlicensed NCPs, manufacturers of unlicensed NCPs
wishing to continue their presence on the market would have to go through the process of
licensing those products. This would bring into regulation a range of products, such as
electronic cigarettes containing nicotine and nicotine gels, which have not previously been
caught by regulation. There would also be a challenge to ensure that we capture within
regulation nicotine containing products without impacting on tobacco products. This,
however, needs to be weighed against the (unknown) risk to public health of the continuing
availability of products which have not been assessed for safety, quality and efficacy, and do
not have the same safeguards in place i.e. the obligations of MA holders.
18. In order to ensure there is no risk to public health from unlicensed products on the
market that have not been assessed for safety, quality and efficacy and in the light of the
developing extent of their use and familiarity we are consulting to elicit views on whether and
how to bring all products containing nicotine into regulation.
What is the problem under consideration? Why is government intervention necessary?
There are a number of products purporting to contain nicotine (including some electronic cigarettes and
topical gels), that are widely available but are not licensed medicines and have therefore not been tested for safety, quality and efficacy. In addition, following advice from the Commission on Human
Medicines (CHM), an extended indication to include a ‘harm reduction’ element for nicotine replacement
therapy (NRT) products has been approved. The extension of the indication to include harm reduction
marks a major shift in approach in medicines regulation. NRT has to date not been licensed for harm
reduction and the decision to do so raises the question of the regulation of other nicotine containing
products (NCPs). The MHRA is consulting on whether to bring all these products within medicines
legislation.
What are the policy objectives and the intended effects?
One option being consulted upon is to bring unlicensed NCPs into medicines regulation, thus protecting
public health from products that have not been assessed for safety, quality and efficacy. The effect of the proposal would be that all unlicensed NCPs will either be removed from the market or manufacturers will have to license them as medicines by a specific date.
Key Assumptions/Sensitivities/Risks
It is assumed that 50% of NCPs will become licensed. A potential risk is the sale of the NCPs from foreign market advertised on the internet as there are virtually no controls on importation for personal use and so it is not possible to prevent products advertised on non-UK websites being sold and supplied to the UK, unless we had a Banning Order in place.
Industry
12. Manufacturers of unlicensed NCPs will need to go through the process of licensing their
products as medicines or make the decision to withdraw their products from the market. If
manufacturers choose to apply for a marketing authorisation (MA) the applications would be
regarded as abridged complex applications and currently attract a fee of £28,780. We
understand there are around 24 manufacturers that produce unlicensed NCPs that are
distributed by around 80 distributors in the UK. We have estimated that there are around 100
unlicensed NCPs that are distributed in the UK and we have assumed that 50% of
22 manufacturers will go through the process of licensing their products, resulting in the licensing
of about 50 products. We would therefore expect to receive 50 applications for MAs at an
estimated one-off cost to industry of £1.439 million. This includes the manufacturer’s licence,
which currently attracts a fee of £3027.
14. We have assumed that 50% of the 24 manufacturers would not choose to go through the process of licensing their products and would therefore choose to withdraw their products from the market in the UK. Therefore around 12 manufacturers would lose sales in the UK and this has yet to be estimated. They do, however, have the option of licensing their products rather than lose their sales and the aim of the DH strategy is to increase the use of substitute nicotine products, which will result in greater profits for those who choose to manufacture these products.
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