| Reclassification |
| POM to P - Additional for MA or PI application with reclassification element from POM to P 3,4 |
12,961
|
| - Reclassification variation application POM to P 3,4 |
12,961
|
| P to GSL - Additional fee for MA or PI application with reclassification element from P to GSL 3,4 |
8,822
|
| - Reclassification variation application P to GSL |
8,822
|
| Reclassification variation application (MA) (analogous product) 4 |
794
|
| Reclassification variation application (PI) (analogous product) |
191
|
| Asessment of labels and leaflets |
| Single or first application 5 |
559
|
| National (BROMI) - Article 61 (3) Notification 6 |
201
|
| Parallel imports |
354
|
|
Notes:
- If a number of such renewal applications are made at the same time and in relation to products with the same active ingredient, dosage form, indications, Periodic Safety Update Report (PSUR) and renewal date, the full fee is charged for the first application, but a fee of £807 will be payable in respect of each of the other applications.
- If a number of such renewal applications are made at the same time and in relation to products with the same active ingredient, dosage form, indications, PSUR and renewal date, the full fee is charged for the first application, but a 50% “discount” applies to each other application.
- Where the Agency is of the view that a reclassification application does not require consideration by a medicines advisory committee a 50% reduction of the fee applies.
- If multiple MA applications with reclassification elements are made at the same time and in relation to products with the same active ingredient, the full additional fee is charged for one application but only £794 for each other application.
If multiple reclassification variation applications are made at the same time and in relation to products with the same active ingredient, the full fee is charged for the one application but in relation to each other application the fee is only £794, or £397 in the case of other applications where there is an analogous product already with the same legal status.
- For all label and leaflet applications, a bulk “discount” applies where a number of simultaneous applications are made for identical changes covering a range of strengths of the same dosage form. The first application is charged at the full rate shown and second and subsequent applications are charged at 50%.
- See the MHRA website for explanation of national leaflets and labels.
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