K
KulrMeStoopid
Guest
http://www.eccauk.org/index.php/latest/electronic-cigarettes-and-the-mhra-numbers-game.html
At the beginning of August, we wrote to Linda McAvan in an attempt to help educate her with regards to the EU TPD and the impact that the proposed MHRA regulation would have on the UK market. She is yet to reply.
The main thrust of our letter was to explain our interpretation of the MHRA 'clarification' on the Licensing Procedure for NCPs (document ref con297583) when read in conjunction with the MHRA Impact Assessment (document ref con286852).
We explained our interpretation of the documents:
...The MHRA figures published on 12th June indicate that this would cost such a vendor between £25.2 Million and £39 Million with a further recurring annual cost between £6.5 Million and £24.9 Million on licensing alone...
Huge numbers for a small vendor.
In the real world, the numbers quickly go from huge to ridiculous. ECigWizard have been told by the MHRA they will need to obtain 900 MA at a cost upwards of £1.8 billion. In other words, at least £2 million for each MA.
Another UK vendor sells 152 flavours of liquid and offers the following options
152x3x4x8x3 = 43,776 'unique' products each requiring MA.
Calculating directly from the lowest figures in the MHRA impact assessment, it means an initial cost of £11 billion and a recurring annual fee of £2.8 billion.
Ridiculous numbers.
However, using the MHRA advice provided to ECigWizard (£2 million per MA) that would mean a cost of £87 billion.
Farcical.
McAvan either has not read, does not understand, or is deliberately misrepresenting, the MHRA proposals.
At the beginning of August, we wrote to Linda McAvan in an attempt to help educate her with regards to the EU TPD and the impact that the proposed MHRA regulation would have on the UK market. She is yet to reply.
The main thrust of our letter was to explain our interpretation of the MHRA 'clarification' on the Licensing Procedure for NCPs (document ref con297583) when read in conjunction with the MHRA Impact Assessment (document ref con286852).
We explained our interpretation of the documents:
...The cost of MA [marketing authorisation] is calculated on a per product basis. The definition of a product is such that any differences in (say) nicotine levels or excipient type would designate the product as distinct …. A vendor offering a 'small' range of products is likely to have a line of 200 'different' liquid items and many have significantly more...
To make life simple, we presented McAvan with an example using only 100 product 'variations' (roughly equivalent to a vendor with 8 flavours, 3 PG/VG combinations and 4 nicotine options):
...The MHRA figures published on 12th June indicate that this would cost such a vendor between £25.2 Million and £39 Million with a further recurring annual cost between £6.5 Million and £24.9 Million on licensing alone...
In the real world, the numbers quickly go from huge to ridiculous. ECigWizard have been told by the MHRA they will need to obtain 900 MA at a cost upwards of £1.8 billion. In other words, at least £2 million for each MA.
Another UK vendor sells 152 flavours of liquid and offers the following options
- 3 flavour strengths
- 4 different PG/VG ratios
- 8 different nicotine strengths
- 3 throat hit versions
152x3x4x8x3 = 43,776 'unique' products each requiring MA.
Calculating directly from the lowest figures in the MHRA impact assessment, it means an initial cost of £11 billion and a recurring annual fee of £2.8 billion.
Ridiculous numbers.
However, using the MHRA advice provided to ECigWizard (£2 million per MA) that would mean a cost of £87 billion.
Farcical.
McAvan either has not read, does not understand, or is deliberately misrepresenting, the MHRA proposals.
