Guidance for filling in the MHRA Consultation

The MHRA, who will be the regulators in the UK for the TPD are asking for responses to a consultation on their proposals – full document here.  Time is short on this – the deadline is Friday 29th January 2016.

They ask for general comments and a further 5 questions relating to the level they have set the fees at:

1. Do you agree or disagree with the levels of the proposed fees in Annex A? If you disagree, please explain why. (The fees are £220 initial notification, £110 to modify it and a £60 yearly fee to continue it)

2. Would you prefer a fixed fee covering a number of modifications to be added to the Periodic Fee? Please provide any information that could justify a change towards this alternative model.

3. Are the proposed fee levels tolerable or will they cause a significant impact on your business’s finances? (please indicate if you represent a small or micro business)

4. Please provide any data or information that will assist us to refine our volume estimates for notifications in Year 1 (16/17) and subsequent modifications.

5. Please provide any data or information that will assist us to refine our volume estimates for notifications after Year 1 (17/18 onwards)

They have said in the full document (link above): “In giving your views on the proposal described in this document, it would be particularly helpful if you could identify and quantify the effects these proposals are likely to have on your business. We would particularly like to hear from smaller companies.”

We have made a set of suggestions to help small businesses to complete this – the MHRA has been, in our view, fair in their proposals (as far as they are able) but they admit to having no clear idea of the size and mix of the UK market, and no clear idea of the effects the TPD may have on the number of viable businesses.

It is clear to us that the combined effects of the notification and testing will have a devastating effect on vaping in the UK, slimming the variety and number of eliquids (for example) on offer drastically – it is vital that the MHRA get as complete a picture of this as possible.

Blank letter to fill in and either attach or copy and paste into your response email – the email should have as the subject:  Fees Consultation MLX 390.  The MHRA have asked for responses to be in this form.

Suggestions to help with responses

Disclaimer:  We are a bunch of volunteer vapers, not experts in regulation, consultation or running a vaping business.  We have pulled in a range of vendors and industry experts to check and advise us but the suggestions and any mistakes are our own.

Any questions, feedback etc., please use the comments.

 

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2 thoughts on “Guidance for filling in the MHRA Consultation

  1. Sent an email asking them why the fees are so high and they should be much lower due to amount of shops both on-line and on the street and why if say a Kanger KBox passes the inpection and is ok why everyone has to pay to sell a device that is safe?

    Also some questions about the 2ml tank limit and what about VV, VW and TC units.

    Like

    1. It is frustrating that they are asking for comments when there is a distinct lack of clarity. They have stated, by the way (in sentence 6 of the first link above), that only pieces of an ecig that come into contact with nicotine need to be notified, so VV, VW and TC units sold separately would not need notification.

      Liked by 1 person

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