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Devices incorporating an ancillary medicinal substance*
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Fee £ | Fee £ |
|---|---|---|
| In respect of a request by Notified Body to the MHRA to supply an additional assessment report | ||
|
Device which incorporates:
|
||
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A known medicinal substance from a source previously used in medicinal products or in medical devices in respect of which MHRA has previously been consulted.
|
4,595 | 909 |
|
A known medicinal substance from a new source.
|
10,711 | 2,542 |
|
A new active substance.
|
46,996 | 11,668 |
|
Notes: 1. Where a device incorporates two or more medicinal substances the fee will relate to one of the substances only - the one which commands the highest fee. 2. The same fee will apply regardless of the strength or concentration of the medicinal substance. But only one fee will apply to multiple applications made at the same time for a range of similar devices (eg a range of catheters made of the same material) incorporating the same medicinal substance at the same level. 3. The fee for an additional assessment report will apply when changes to the device require assessment under the terms of the Directive and at any time after the initial assessment when further data is submitted to the MHRA for assessment. |
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*Assessment of the medicinal substance aspects of the device product. For more information see our section on devices incorporating an ancillary medicinal substance.
