Parallel submission administrative reductions
Updated 4 July 2024
Applies to Northern Ireland
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As we operate on a cost recovery basis, fees are charged in order to cover the work undertaken by the VMD. In cases where parallel submissions are made, some fees for the parallel NI applications will be administratively reduced. The reduced fees will take account of the additional administrative activities we will need to perform.
1. New GB MA and national only NI MA
| Fee code | Description | Fee from 01/01/2021 |
|---|---|---|
| NI01 | New pharmaceutical or immunological parallel submission for identical national GB and NI MAs. Full fee in respect of the GB MA plus reduced fee per application | 685 |
2. New GB MA and decentralised procedure MA with NI as CMS
| Fee code | Description | Fee from 01/01/2021 |
|---|---|---|
| NI02 | New pharmaceutical or immunological parallel submission for identical GB MA and mutually recognised MA with NI as CMS. Full fee in respect of the GB MA plus reduced fee per application | 2,895 |
3. Variations: GB MA and national NI MA
| Fee code | Description | Reduced fee for NI application from 01/01/2021 |
|---|---|---|
| NI03 | Type IA [now referred to as a Variation Not Requiring Assessment (VNRA)]: parallel submission of identical Type I A changes to identical national GB MA and NI MAs. The full fee is charged for the application to the GB MA plus a reduced fee for the application to the NI MA | 273 |
| NI04 | Type IB [now referred to as a Variation Requiring Assessment (VRA) -reduced]: parallel submission of identical Type IB changes to identical national GB MA and NI MAs. The full fee is charged for the application to the GB MA plus reduced fee for the application to the NI MA. | 273 |
| NI05 | Type II [now referred to as a Variation Requiring Assessment (VRA) – standard / extended]: parallel submission of identical Type II changes to identical national GB MA and NI MAs. The full fee is charged for the application to the GB MA plus reduced fee for the application to the NI MA. | 273 |
4. Variations: GB MA and mutually recognised NI MA
| Fee code | Description | Reduced fee for NI applications from 01/01/2021 |
|---|---|---|
| NI06 | Type II [now referred to as a Variation Requiring Assessment (VRA – standard / extended: parallel submission of identical Type II changes to identical national GB MA and mutually recognised NI MA. The full fee in respect of the application for the GB MA plus reduced fee for the application to the mutually recognised NI MA | 531 |
The full CMS fee in respect of VNRA and VRA – reduced, will apply to mutually recognised NI MAs.
5. Provision of advice
| Fee Code | Description | Fee from 01/10/13 | VMR 2013 SCH 7 Para |
|---|---|---|---|
| ADV1 | The fee for an application for written advice from the Secretary of State as to whether a product requires a marketing authorisation | 885 | 54 |