How to get a Manufacturing Authorisation: Autogenous Vaccine (AVA), Non-Food Animal Blood Bank (NFABBA), or Equine Stem Cell Centre (ESCCA).
How to apply
The following application forms are available:
All applications are checked (validated) upon receipt.
It is up to you to identify and submit all the necessary information in support of your application. If the application is incomplete, it is likely to fail validation.
Once the application has passed validation, it will proceed into the assessment phase.
The timescales may be suspended if we need further information from you, or other third party, and if an inspection of the premises is needed.
If the outcome is to approve an application, you will be sent authorisation documentation at the end of the application procedure.
The following timescales apply for new and variation applications:
- Validated within 10 days of receipt
- Approved or refused within 45 clock days of validation passed
- Following approval, updated authorisation documentation will be issued within 10 days
The fees for applying for a new AVA are as follows:
- Site in the UK - £3435
- Site outside the UK - £3270
The fees for each inspection conducted after an authorisation has been granted are the same as above.
The fee to vary an AVA-S is £305 if no further inspection is required, or the full fee if an inspection if required.
The fee for a new AVA-I is £1635
The fee to apply for a new NFABBA is:
- £3113 for the first inspection
- £3113 for subsequent inspections for sites in the UK
- £2966 for subsequent inspections for sites outside the UK
The fee to vary an NFABBA is £320.
The fee to apply for an ESCCA is:
- £3427 for the first inspection
- £3092 for subsequent inspections
The fee to vary an ESCCA is £320.
The VMD now issues all invoices electronically, you must provide a valid email address of where to send the invoice.