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Detail of outcome
The responses to the consultation show that respondents were largely against proposals to introduce statutory fees to cover regulatory activity relating to E-cigarette products. Some respondents agreed in principle with the charging of fees but expressed concerns about the impact.
New information was provided at consultation that previous volume estimates had been too low. Based on calculations and estimates provided by industry and trade associations, it is now estimated that MHRA may expect as many as 14,000 notifications in the first year (20 May 16 to 31 Mar 17).
Based on the new higher volume estimates provided by industry the fees as proposed at consultation are judged to be high and could run the risk of over recovery against costs. Using the new volume estimate, along with an appreciation of the remaining significant uncertainty, it has been possible to reduce the fees.
This proposal introduces new fees for producers and importers of e-cigarettes in order for MHRA to cover the costs of processing the notifications and carrying out post-marketing vigilance work.
The fees passed on to business will be the minimum possible to ensure the costs incurred by MHRA are recovered.
The implementation date for these changes is 20 May 2016.
To respond to the consultation you should email the proforma in Annex B of the consultation document to email@example.com with “Fees Consultation MLX 390” as the subject.
Emailed responses are preferred, but if you want to send your response by post, the address is:
E-cigarette Fees Consultation
c/o Matthew Garland,
5th Floor, Teal Area
151 Buckingham Palace Road