Consultation outcome

Regulatory fees for medicines: 2016 to 2017 and fees for online sellers of medicines

This consultation has concluded

Download the full outcome

Regulatory fees for medicines: 2016 to 2017 and fees for online sellers of medicines - consultation response

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Annex A: summary of fee changes

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Annex B: Regulatory Triage Assessment - MHRA fees reduction

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Annex C: Regulatory Triage Assessment - fees for online sellers of medicines

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Detail of outcome

The evidence provided by the responses to the consultation shows that there is broad support for the decrease in licence fees. Therefore the fees proposed in the consultation will go ahead unchanged. See Annex A for details.

There is mixed support for the introduction of a fee to fund the FMD logo scheme. MHRA aims to charge businesses a fee equal to the cost of services they have received and will be maintaining one fee for all online sellers. The fees are set out in Annex A.

Original consultation

This consultation ran from to

Summary

This consultation seeks views on the reduction of some fees for the regulation of medicines and the introduction of fees for online sellers of medicines (MLX 389).

Documents

Consultation document: Regulatory fees for medicines: 2016 to 2017 and fees for online sellers of medicine

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Regulatory triage assessment: medicine fee changes

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Regulatory triage assessment: fees for online sellers of medicine

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Consultation description

The Medicines and Healthcare products Regulatory Agency (MHRA) plans to reduce some of its existing statutory fees by between 10 and 15%. MHRA only makes adjustments to fees as and when necessary and may make further fee changes in 2017/18 if required.

From 1 July 2015, MHRA has operated a statutory registration scheme and logo system for UK-based online sellers of medicines. MHRA proposes to introduce a fee to recover the costs of operating this scheme.

Any comments on these proposals should be sent to the email address below by 19 November 2015 using the reply sheet in Annex C of the consultation document. the subject of the email should be ‘Fees consultation MLX 389’. Email responses are preferred but you can post responses to the address below.