Manufacturers authorisation and Inspections
Published 16 May 2024
Applies to Northern Ireland
© Crown copyright 2024
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This publication is available at https://www.gov.uk/government/publications/fees-applied-to-veterinary-medicine-authorisation-applications-in-northern-ireland/manufacturers-authorisation-and-inspections
1. Manufacturers authorisation
Fees with an asterisk* have been reduced to match the fees paid in Great Britain as stated in the VMR 2013 (as amended). The reduction applies to manufacturers in NI where the current VMR 2013 applicable in NI is higher than the GB VMR 2013 (as amended). In such cases, the relevant fee applicable in NI is shown in the table below.
| Fee code | Description | Fee from 01/10/13 | VMR 2013 SCH 7 Para |
|---|---|---|---|
| MA60 | Application | 762* | 28(a) |
| MA06 | Application: Schedule 6 products | 530 | 28(b) |
| MV60 | Variation requiring scientific or pharmaceutical assessment | 636 | 29(a) |
| MV62 | Variation; change of ownership | 105* | 29(b) |
| MV13 | Variation; Schedule 6 products | 105* | 29(c) |
| MV70 | Variation not requiring scientific or pharmaceutical assessment | 105* | 29(d) |
| MAU1 | Autogenous vaccine: authorisation for each UK manufacturing site | 3,435 | 30(1)a |
| MAU2 | Autogenous vaccine: authorisation for each non-UK manufacturing site | 3,270 | 30(1)b |
| MAS1 | Autogenous vaccine : single batch | 1,635 | 30(3) |
| MAV1 | Autogenous vaccine: variation to manufacturing site details requiring inspection - UK site | 3,435 | 30(1)a |
| MAV3 | Autogenous vaccine: variation to manufacturing site details requiring inspection - non-UK site | 3,270 | 30(1)b |
| MAV2 | Autogenous vaccine: variation to manufacturing site details - not requiring inspection | 105* | 30(4) |
| MF60 | Annual Fee: other than autogenous vaccines | 550 | 31(1) |
| YGAF3 | Annual Fee: autogenous vaccines | 575* | 31(2) |
| N/A | Annual fee: Schedule 6 products | no fee | 31(3) |
1.1 Manufacturing site inspections
If a site is inspected for more than 1 type of authorisation at the same time, the inspection fee payable is the highest inspection fee plus 50% of any other applicable inspection fees.
2. Immunological site inspections
| Fee code | Description | Fee from 01/10/13 | VMR 2013 SCH 7 Para |
|---|---|---|---|
| SS40 | Super site | 24,071 | 33 |
| SS10 | Major site | 16,785 | 33 |
| SS20 | Standard site | 6,661 | 33 |
| SS30 | Minor site | 4,757 | 33 |
| SO33 | Autogenous vaccine site | 3,435 | 30(1)a |
3. Pharmaceutical site inspections
| Fee code | Description | Fee from 01/10/13 | VMR 2013 SCH 7 Para |
|---|---|---|---|
| SS91 | Super site: Sterile | 23,324 | 34 |
| SS61 | Major site: Sterile | 13,010 | 34 |
| SS71 | Standard site: Sterile | 8,244 | 34 |
| SS81 | Minor site: Sterile | 5,022 | 34 |
| SO91 | Super site: non-sterile | 14,180 | 35 |
| SO61 | Major site: non-sterile | 8,325 | 35 |
| SO71 | Standard site: non-sterile | 6,854 | 35 |
| SO81 | Minor site: non-sterile | 3,789 | 35 |
| SA91 | Super site: Assembly of products only | 11,025 | 36 |
| SA61 | Major site: Assembly of products only | 5,949 | 36 |
| SA71 | Standard site: Assembly of products only | 4,917 | 36 |
| SA81 | Minor site: Assembly of products only | 2,035 | 36 |
| SO34 | Standard site: Schedule 6 products only | 5,055 | 35 |
| SO32 | Minor site: Schedule 6 products only | 2,728 | 35 |