MMF- Application for approval of
premises for the MANUFACTURE of
medicated feedingstuffs and
specified feed additives
(Schedule 5 products)
The Veterinary Medicine Regulations 2013
(as amended)
Please indicate the type of approval/registration that you wish to apply for:
Manufacturing activity
Category Note: Where more than one manufacturing activity is carried out at one
establishment only the highest fee is payable.
Tick all
that
apply

Fee
payable
£
1.
Establishment manufacturing a specified feed additive (a):
545.00
2.
Establishment manufacturing a premixture:
435.00
3.
Establishment manufacturing feedingstuffs using specified feed additives
and veterinary medicinal products directly at any concentration, or using
premixtures or specified feed additive complementary feedingstuffs:
435.00
4.
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 2 kg
per tonne or more:
320.00
5.
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:
170.00
6
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 2 kg
per tonne or more:
131.00
6F
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.
131.00
7
Establishment manufacturing feedingstuffs using premixtures containing
specified feed additives when the feedingstuffs are to be used by the
person manufacturing the feedingstuffs:
110.00
Establishment manufacturing feedingstuffs using complementary
feedingstuffs containing specified feed additives, for feeding to the
manufacturer’s own animals:
No fee
7R
(a)
No fee is payable for establishments that already have a manufacturing authority relating to
veterinary medicinal products for incorporating into feedingstuffs.
Agri-food Inspection Branch
Feed & Food Inspectorate
Application form MMF
Issue
Date
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THIS IS NOT AN INVOICE – DO NOT SEND PAYMENT WITH THIS APPLICATION FORM
Section 1 – Applicant’s Details
Section 2 – Premises Details (where activity is
carried out)
Applicant’s name:
Trading Name (if different form applicant’s/corporate body or
company name)
Corporate body/Company Name
Address (if different from applicant’s address)
Address:
Postcode:
Postcode:
Tel. No:
Tel. No:
Mob. No:
Mob. No:
Fax No:
Fax No:
E-mail address:
E-mail address:
Website:
Website:
Additional information eg opening
hours, specific biosecurity measures:
Species of animals kept (where
applicable):
*Cattle / Sheep / Pigs / Poultry / Other (give details):
*delete as applicable
What mixing equipment is used?
Wet-feeding system? (if applicable)
Agri-food Inspection Branch
Feed & Food Inspectorate
Application form MMF
Yes
No
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Section 3 – Designated Persons (Responsible for Production)
Title: Dr / Mr / Mrs / Miss / Ms
(delete where applicable)
Title: Dr / Mr / Mrs / Miss / Ms
(delete where applicable)
First name:
First name:
Surname:
Surname:
Tel. No:
Tel. No:
Mob. No:
Mob. No:
Fax No:
Fax No:
E-mail address:
E-mail address:
Section 4 – Declaration
Please Note:
A separate application form must be submitted for each premises for which approval or
registration is required.
Declaration
I confirm that I have read the requirements for approval/registration 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.
Please note that once an application has been received and an approval inspection
carried out, fees are not refundable.
Signed: ________________________________________________
Print Name: _
Date: ___
____________________________________________
______________
Position in Company: __
Agri-food Inspection Branch
Feed & Food Inspectorate
Application form MMF
____________________________________
Issue
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DARD will use the information you have compulsorily provided to fulfil its statutory functions,
which includes publishing the premises name & 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.
The summary of requirements for premises approval and registration can be found in
Veterinary Medicines Guidance Note No.17 – Medicated Feedingstuffs and Specified Feed
Additives on the VMD website: www.vmd.defra.gov.uk or by contacting Agri-food Inspection
Branch, DARD on Tel: (028) 9076 5868.
Farmers manufacturing feedingstuffs using veterinary medicinal products, or
premixtures containing veterinary medicinal products or specified feed additives, should
note the attached checklist.
Please do NOT send any payment now as an invoice from our accounts branch will follow on
receipt of your application form.
Section 5 - Return of Application Form
Please return completed application form to:
Department of Agriculture and Rural Development
Agri-food Inspection Branch
Room 1018, Dundonald House
Upper Newtownards Road
Dundonald
Belfast
BT4 3SB.
Enquiries to:
Tel: (028) 9076 5868
Tel: (028) 9076 5379
Fax: (028) 9052 4671
E-mail: afib.admin@dardni.gov.uk
Agri-food Inspection Branch
Feed & Food Inspectorate
Application form MMF
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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:
 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.
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.
Agri-food Inspection Branch
Feed & Food Inspectorate
Application form MMF
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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:
- mixer efficiency (homogeneity) tests
- carryover (cross-contamination) tests
- calibration of weighing/measuring equipment
- 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:
Department of Agriculture and Rural Development
Agri-food Inspection Branch
Room 1018
Dundonald House
Upper Newtownards Road
Ballymiscaw
Dundonald
Belfast
BT4 3SB.
Tel: (028) 9076 5868
E-mail :lorraine.colgan@dardni.gov.uk
E-mail: gerard.higgins@dardni.gov.uk
Agri-food Inspection Branch
Feed & Food Inspectorate
Application form MMF
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