Guidance

Manufacturers authorisation and Inspections

Updated 4 July 2024

Applies to Northern Ireland

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