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The Veterinary Medicines Regulations
Application for Approval of Premises for the manufacture of
Schedule 5 products
Please indicate the type of approval that you wish to apply for:Office Use
FDA1 £70
FDN1 £1810
FDA2 £70
FDN2 £1090
Category
Schedule 5 activity for which approval is required
Fee
Payable
1
As an establishment manufacturing a specified feed additive
£1880
2
As an establishment manufacturing a premixture
£1160
FDA3 £70
FDN3 £1090
3
As an establishment manufacturing feedingstuffs using specified feed
additives and veterinary medicinal products directly at any concentration, or
using premixtures or specified feed additive complementary feedingstuffs
£1160
FDA4 £70
FDN4 £961
4
FDA5 £70
FDN5 £405
5
FDA6 £70
FDN6 £320
6
FDA6 £70
FDN6 £320
6F
FDA7 £70
FDN7 £240
7
7R
As an establishment manufacturing feedingstuffs for placing on the market
using a veterinary medicinal product or premixture where the concentration
of veterinary medicinal product in the feedingstuffs is 2kg per tonne or more
As an establishment manufacturing feedingstuffs using premixtures or
specified feed additive complementary feedingstuffs containing specified
feed additives when the feedingstuffs are to be placed on the market
As an establishment manufacturing feedingstuffs for the manufacturers own
use using a veterinary medicinal product or premixture where the
concentration of veterinary medicinal product in the feedingstuffs is 2kg per
tonne or more
As an establishment manufacturing feedingstuffs for fish for the
manufacturers own use using a veterinary medicinal product or premixture
where the concentration of veterinary medicinal product in the feedingstuffs
is 2kg per tonne or more
As an establishment manufacturing feedingstuffs using premixtures containing
specified feed additives when the feedingstuffs are to be used by the person
manufacturing the feedingstuffs
As an establishment manufacturing feedingstuffs using complementary
feedingstuffs containing specified feed additives, for feeding to the
manufacturer’s own animals
Veterinary Medicines Directorate
Woodham Lane, New Haw, Addlestone, Surrey KT15 3LS
Telephone +44 (0)1932 336911
Search for VMD on GOV.UK
The Veterinary Medicines Directorate is an Executive Agency of the Department for Environment, Food and Rural Affairs
Tick

£1031
£475
£390
£390
£310
No Fee
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Feedingstuffs Manufacturer’s Application Form
PLEASE COMPLETE ALL RELEVANT SECTIONS OF THIS FORM
IN BLOCK CAPITALS
Section 1
Applicant’s Details
Owner’s Reference Number
[if known]
Applicant’s Name
Corporate Body/
Company Name
Address
___________________________________
___________________________________
___________________________________
___________________________________
Post Code: _________________________
Telephone No.
.
Mobile No.
Fax No.
E-mail address
Website
2
Section 2
Premises Details
[where activity will be carried out]
Trading Name
[if different from applicant’s/
corporate body or company
name]
Address
[if different from
applicant’s address]
________________________________
________________________________
________________________________
Post Code: ________________________
Telephone No.
.
Mobile No.
Fax No.
E-mail address
Website
CPH No. [where applicable]
Additional Information
e.g. Opening hours,
specific biosecurity measures
____________________________________
____________________________________
____________________________________
Species of Animals Kept
[delete where applicable]
CATTLE/SHEEP/PIGS/POULTRY/OTHER
Other: [give details]
Medication to be used
What mixing equipment is
used
Do you hold any other VMD approval(s)/authorisation(s) for this premises’? YES/NO
If so, please provide the premises reference number
3
Section 3
Designated Persons
[Responsible for Production]
Title
Dr/Mr/Mrs/Miss/Ms
[delete where applicable]
First Name(s)
Surname
Telephone No.
.
Mobile No.
Title
Dr/Mr/Mrs/Miss/Ms
[delete where applicable]
First Name(s)
Surname
Telephone No.
.
Mobile No.
Section 4
Veterinary Practice Details
Vet Name
Practice Name
________________________________
________________________________
________________________________
Post Code: ________________________
Telephone No.
Mobile No.
Email address
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Section 5
Declaration
Please Note:
A separate application form must be submitted for each premises’ for which approval is
required.
Declaration
I confirm that I have read the requirements for approval as a manufacturer of Schedule 5
products under the current Veterinary Medicines Regulations, and hereby declare that
the said premises, equipment and procedures meet the requirements [1] and are ready
for inspection.
On receipt of the application form a HACCP and documentation pack will be sent out for
completion in time for the inspection
Please note that once an application has been received and an approval inspection
carried out, fees are not refundable
Signed:
Date:
Print Name:
Position in Company:
The completed application form, along with cheque payment for appropriate fee (made payable
to Veterinary Medicines Directorate), should be returned to:
Accounts Payable
Veterinary Medicines Directorate
Woodham Lane
New Haw
ADDLESTONE
Surrey KT15 3LS
[If you wish to pay by bank transfer, the details are as follows:
Bank: Citi Direct Account No: 12265923
Account Name: GBS – Re DEFRA-VMD]
Sort Code: 08-33-00
The Veterinary Medicines Directorate will use the information you have compulsorily provided to fulfil its statutory
functions, which includes publishing the premises address in the Register of Approved/ Registered Feedingstuffs
Manufacturers & Distributors. Otherwise, the information will not be disclosed to third parties without your consent.
The information held is subject to current data protection legislation.
[1]The summary of requirements for premises approval and registration can be found in Guidance for
manufacturers and suppliers of veterinary medicines for incorporation into animal feedingstuffs (previously VMGN
17) on the .GOV.UK website https://www.gov.uk/guidance/manufacturing-and-supplying-veterinary-medicines-foranimal-feed or by contacting the Inspections Administration Team on: +44 (0)1932 338475 or email
inspections@vmd.defra.gsi.gov.uk. Farmers manufacturing feedingstuffs using veterinary medicinal
products, or premixtures containing veterinary medicinal products or specified feed additives, should
also read the attached checklist.
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Checklist for farmers mixing animal feedingstuffs
containing Controlled Products
Controlled Products
In this checklist, Controlled Products refer to:



Veterinary Medicinal Products (VMPs) authorised for mixing into animal feed;
Specified Feed Additives (SFAs) i.e. coccidiostats and growth promoters; and
Premixtures containing VMPs or SFAs.
Premises & Equipment
Ensure that all parts of the premises and equipment used for mixing feeds, including associated storage
areas, are:
□
□
□
□
□
□
In a good state of repair.
Clean and tidy.
Free from spillages, old packaging and obsolete equipment.
Protected from the entrance and harbouring of pests, vermin and domestic animals.
Well lit, ventilated and dry.
Suitable to accurately mix feeds and protect feeds from contamination.
Personnel
Ensure that:
□ There is a designated person responsible for feed production.
□ Staff are trained and knowledgeable in handling Controlled Products and mixing feeds.
□ Appropriate staff facilities and personal protective equipment are available.
Production
Ensure that procedures are in place so:
□ Feed materials are sourced from appropriate suppliers and measures are taken to minimise the
risk from contaminants and prohibited/undesirable substances.
□ Feeds are mixed according to written formulations and instructions aimed at minimising crosscontamination during mixing, storage and transport.
□ Veterinary medicines are only used in accordance with a valid Medicated Feedingstuff (MFS)
prescription.
□ Other Controlled Products are only used ’as labelled’.
□ Waste material not suitable for feed is isolated and identified for disposal.
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Storage & Transport
Ensure that:
□ Controlled Products are stored in their original packaging and in a secure location.
□ Storage areas for feed materials and mixed feed are suitable to prevent contamination and pest
damage.
□ All feed materials and mixed feeds are labelled or otherwise clearly identifiable.
□ Mixed feeds are transported in suitable vehicles or containers, which are cleaned as necessary
to prevent cross-contamination.
Quality Control
Ensure that a Quality Control plan is drawn up which includes:
□
□
□
□
□
Keeping samples of mixed feeds.
Testing the efficiency of the mixer (homogeneity test).
Testing samples of mixed feed for Controlled Products and other substances.
Testing mixed feed for cross-contamination (carryover) where there is a risk.
Monitoring feed materials and mixed feeds for harmful organisms and deleterious substances.
Record-keeping
Ensure that appropriate records are kept of the following:
□
□
□
□
□
Controlled Products and feed materials purchased.
Feeds mixed and details of the Controlled Products used (including batch numbers).
MFS prescriptions to cover purchase and use of VMPs and medicated premixtures.
Documented Procedures for feed production.
Quality Control results:
o mixer efficiency (homogeneity) tests
o carryover (cross-contamination) tests
o calibration of weighing/measuring equipment
o analysis of mixed feeds and feed materials
□ Cleaning and maintenance of premises, storage areas and equipment.
□ HACCP plan.
□ All records are kept for 5 years.
Further guidance is available from:
The Inspections Administration Team
VMD
Woodham Lane
New Haw
ADDLESTONE
Surrey KT15 3LS
Tel:
+44 (0)1932 338475
E-mail: inspections@vmd.defra.gsi.gov.uk
VMD website: www.gov.uk
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