Guidance for manufacturers and suppliers of veterinary medicines for incorporation into animal feedingstuffs.
This guidance should be read together with Schedule 5 of the Veterinary Medicines Regulations (VMR).
There are a number of different approvals for feed businesses and they are split into different categories depending on the activity carried out at the establishment (premises). These are:
|1||Establishment approved to manufacture a specified feed additive (SFA)|
|2||Establishment approved to manufacture a premixture|
|3||Establishment approved to manufacture feedingstuffs using specified feed additives and veterinary medicines directly at any concentration, or using premixtures.|
|4||Establishment approved to manufacture feedingstuffs for placing on the market using a veterinary medicine or premixture where the concentration of a medicine in the feedingstuffs is 2 kg per tonne or more.|
|5||Establishment approved to manufacture feedingstuffs using premixtures containing specified feed additives when the feedingstuffs are to be placed on the market.|
|6||Establishment approved to manufacture feedingstuffs for feeding to the manufacturers own animals, using a veterinary medicinal product or premixture where the concentration of veterinary medicinal product in the feedingstuffs is 2 kg per tonne or more.|
|6F||Establishment approved to manufacture feedingstuffs for feeding to the manufacturers own fish, using a veterinary medicinal product or premixture where the concentration of veterinary medicine in the feedingstuffs is 2 kg per tonne or more.|
|7||Establishment to manufacture feedingstuffs using premixtures containing specified feed additives when the feedingstuffs are to be used by the person manufacturing the feedingstuffs.|
|8||Distributor approved to sell, supply or store specified feed additives, premixtures or feedingstuffs containing specified feed additives, or premixtures or feedingstuffs containing veterinary medicines.|
Approval – Requirements for manufacturers of Schedule 5 products
A Feed Business Operator (FeBO) that manufactures and supplies the following products must be approved and comply with Schedule 5 of the VMR:
- specified feed additives (SFAs)
- premixtures containing SFAs or veterinary medicines
- complementary feedingstuffs containing SFAs
- complete feedingstuffs containing SFAs or veterinary medicines
Approved FeBOs are inspected regularly and must meet strict inspection criteria. Information on the requirements for approval can be found in the application form and the HACCP guidance which are available on the Animal feedingstuffs registration page.
The inspection frequency is risk based and depends on the nature of the FeBO and its compliance with the VMR.
FeBOs that manufacture Schedule 5 products for feeding to their own animals on their own holdings must also comply with these requirements. However, those that only manufacture complete feedingstuffs using complementary feedingstuffs that contain SFAs must be registered rather than approved.
Designated Qualified Persons
You are required to name a qualified person responsible for production (Qualified Person for Feedingstuffs - Production (QPFP). You may also require a responsible person for Quality Control (Qualified Person for Feedingstuffs Quality (QPFQ)). These should be different people but in a small business where this is not practical it can be the same person. Or the QPFQ may be someone outside the business e.g. your nutritional adviser.
Any person capable of competently performing the following duties can be a QPFP or QPFC. Specific qualifications are not required.
Qualified Person for Feedingstuffs production
A QPFP is responsible for:
- the written procedures and instructions that define, check and monitor the critical points in the manufacturing process
- ensuring that measures are taken to avoid or minimise, any cross-contamination and errors
- ensuring appropriate control strategies are put in place to minimise risk
- ensuring that waste and materials not suitable as feed are isolated, identified and disposed of in the correct way so they are not used as feed
- following the quality control plan (see below)
- ensuring adequate measures are taken to ensure effective tracing of the products
Qualified Person for Feedingstuffs quality
A QPFQ is responsible for ensuring that they use a laboratory with adequate staff and equipment as part of a quality control system. They must also write up and implement a quality control plan. This should include:
- checks on the critical points in the manufacturing process
- monitoring the presence of micro-organisms, prohibited feed, undesirable substances and other contaminants in relation to human or animal health
- a description of the tests that need to be carried out and their frequencies. As a minimum the tests should include:
- an annual mixer dispersion test
- routine tests on the amount of active substance of the SFA (or veterinary medicine) in the finished product
- testing for carryover of active substances into non-target products
- how analysed results are compared against product specifications - what action is taken for compliant and non-compliant samples
- the destination of feed materials or finished products in the event of non-compliance
QPFQ must keep records to enable traceability of feed materials (ingredients) from intake through to the manufacture and supply of final products.
They must ensure records are available to the competent authorities for an appropriate period (at least until the shelf life of the manufactured product has passed). For veterinary medicines, SFAs, premixtures containing VMPs or SFAs, or complementary feedingstuffs containing SFAs, used to manufacture other Schedule 5 products, this should be 5 years.
Samples of sufficient quantities of feed materials and of each batch of products manufactured and placed on the market must be taken and kept for an appropriate period (at least until the shelf life of the manufactured product has passed).
If the production is continuous then samples should be taken during each part of production using a pre-established procedure in order to ensure traceability.
Retained samples must be sealed and labelled for easy identification and stored appropriately to maintain the sample’s integrity. Only samples of the finished product need to be kept of feedingstuffs for non-food producing animals. Samples should be made available to an inspector on request.
Exemption from approval
The only exemptions from the requirement to be approved are covered in Schedule 5 of the VMR:
a person who incorporates a veterinary medicine into feedingstuffs in domestic premises for feeding on those premises: * non food producing animals * food producing animals kept purely for domestic purposes, including consumption by the keeper of those animals. The sale of animals or animal products to third parties, which includes farm gate sales of eggs, milk and meat, is not considered as domestic purposes and the exemption from approval does not apply.
a person who incorporates VMPs into feedingstuffs for ornamental fish not intended for human consumption, providing that person does not use more than a total of 1kg of VMP annually for that purpose.
In these instances a prescription is still required in order to obtain the veterinary medicine. Under the exemption, the prescription can be either oral or in writing. However, if the prescription is not in writing, the veterinary medicine may only be supplied by the person who prescribed it and appropriate advice on safe use must be given.
This exemption allows a vet, pharmacist or appropriately registered Suitably Qualified Person (SQP) to supply a premixture containing a veterinary medicine, or a feedingstuff containing a veterinary medicine to domestic keepers of animals.
An SQP cannot use this exemption to supply any premixtures or feedingstuffs containing Prescription Only Medicine – Veterinarian (POM-V) medicines.
The Approval Inspection
An inspection of the proposed manufacturing premises is arranged after an application is received.
The aim is to ensure that the FeBO’s premises comply with basic, minimum standards set out in legislation. The inspector will check:
- facilities and equipment are suitable for the operation
- appropriate record keeping plans are in place, particularly relating to medicated feedingstuffs prescription (MFSp) and traceability. Further information can be found on the Record keeping requirements for veterinary medicines page.
- hygiene standards
- storage arrangements for Schedule 5 products
- documentation relating to procedures and controls, including a Quality Control plan and a HACCP plan
The inspector will provide advice to help the FeBO meet the requirements of the VMR. However, the approval may be refused if the premises, equipment or procedures do not meet the required standards. In this case, the inspector will explain the reasons why and the measures that must be taken in order to obtain approval. A FeBO can appeal this decision and more information on the Appeal against a regulatory decision made by the VMD page.
Requirement for Manufacturers of complete feedingstuffs using complementary feedingstuffs containing Specified Feed Additives for the exclusive requirements of their own holdings.
FeBOs that want to manufacture complete feedingstuffs using complementary feedingstuffs containing SFAs for the exclusive requirements of their own holdings must be registered rather than approved. These feed business operators must meet the applicable criteria set out in Annex II of Regulation EC/183/2005, with the exception of Hazard Analysis & Critical Control Points(HACCP). These are not subject to an inspection prior to registration.
Commercial FeBOs manufacturing these products still need to be approved.
What a Registration Inspection covers
Although these FeBOs are not subject to an inspection prior to registration, they will still be subject to regular inspections. The aim is to check that the premises, equipment and procedures are capable of producing Schedule 5 products to the required standard.
Approval requirements for Distributors of Schedule 5 products
A Distributor is a feed business operator who is approved to store, supply, wrap or package;
- premixtures containing SFAs or veterinary medicines
- complementary feedingstuffs containing SFAs
- feedingstuffs containing veterinary medicines
There is no requirement for approval to store or supply complete feedingstuffs containing SFAs.
Distributors of Schedule 5 products must meet the criteria set out in the Distributor’s application form.
A category 8 Distributor may not retail veterinary medicines.
Distributors who act purely as traders and do not hold products on their premises must still be approved. However, such traders can either choose to have an on-site inspection or to be exempted from inspection by submitting a declaration as required by Article 17 of Regulation EC/183/2005. The declaration requires traders to send details of the products they’ve traded in.
Approval as a feedingstuffs’ manufacturer (other than category 6 or 7) permits the supply of that manufacturer’s own product, but not those manufactured by third parties. They would also need to be approved as a Distributor if they wanted to do this. Where businesses with more than one approval are inspected at the same time, the highest fee is payable plus 50% of all other inspection fees (Schedule 7, para 4 of the VMR).
A toll manufacturer is a manufacturer who provides a manufacturing service on behalf of another, to that manufacturer’s specific request to a specific specification and formulation (contract manufacturing). Only toll manufacturers are permitted to supply another manufacturer in this way without being approved as a Distributor.
How to apply for Approval or Registration
Details of how to apply can be found on the Animal feedingstuffs registration page.
Details of the fees involved can be found on the Fees charged for feedingstuffs applications and SQP retailers page.
Labelling of Schedule 5 products
All Schedule 5 products placed on the market must be labelled in accordance with paragraphs 12-14 of the VMR.
For feedingstuffs containing a SFA the labelling requirements are detailed in article 15 and 17 of Regulation EC/767/2009.
Labels must be clear, legible and indelible and be written in English. They may also contain other languages but the information in each language must be the same.
Where more than one SFA or veterinary medicine is incorporated into a feedingstuff the shortest in-feed shelf life must be shown on the label.
If there is no prescription at the time of labelling, the withdrawal period must be that specified in the veterinary medicine’s summary of product characteristics (SPC). If there is more than one medicine the longest withdrawal period must be used. The label must also state “If the prescription requires a longer withdrawal period that is the one that applies”.
Labelling requirements for SFAs, premixtures containing SFAs and complementary feedingstuffs containing SFAs are detailed in Regulation EC/1831/2003.
For a product manufactured by a toll manufacturer, the establishment approval number of the toll manufacturer and the name and address of the receiving manufacturer must appear on the label.
Medicated Feedingstuffs prescriptions
Information on Medicated Feedingstuffs prescriptions (MFSps) can be found in paragraphs 19 and 20 of Schedule 5 of the VMR.
Only a vet may prescribe the manufacture of a feedingstuff containing a VMP classified as POM-V, and the MFSp must be in writing. The vet who prescribes it has responsibility for the details entered on the MFSp.
The vet may discuss a MFSp with a feed mill but should only accept a request for a MFSp from a mill if they believe there is an actual need for a prescription. Feed mills should avoid making unsolicited approaches to vets with draft prescriptions for their approval. If an animal keeper approaches a feed supplier without an MFSp when one is required they should be told to contact their vet.
In the case of an anthelmintic (wormer) classified as Prescription Only Medicine - Veterinarian, Pharmacist, Suitably Qualified Person (POM-VPS), the MFSp may be written by a vet, pharmacist or Suitably Qualified Person (SQP). The following paragraphs refer to the prescribing of MFS by vets, but the same requirements apply to pharmacists and SQPs prescribing feedingstuffs containing a POM-VPS anthelmintic.
An MFSp must be written, in ink or other indelible format, or it may be produced and sent electronically or by fax.
An MFSp for a medicated feed used via a medicated premixture requires extra details. The MFSp must include clear instructions regarding:
- the inclusion rate of the VMP into the premixture
- the subsequent range of acceptable inclusion rate of the premixture into the final feedingstuffs
- the range of acceptable levels of the active ingredients in the final feedingstuffs
The words “refer to the prescription for the exact inclusion rate” or equivalent wording should also appear.
The MFSp must be signed by the vet. A per pro signature is not acceptable. The vet must check that the MFSp has been completed correctly before authorising its issue.
If the MFSp is for a medicated feed containing one or more antibiotics, vets are strongly advised to make it valid for no more than one month.
A MFSp is valid from the date the vet signs it. If a vet prescribes a feed containing antibiotics and states that it’s valid for one month then the prescribed feed may only be supplied within one month of the date the MFSp was signed. After this date a new MFSp will be needed if further medicated feed is required.
The vet must only prescribe enough medicated feed for one course of treatment. The quantities must be within the maximum limits laid down in the SPC.
When two veterinary medicines are being incorporated into the same feedingstuff, the vet may write one MFSp, provided that:
- the medicines are being mixed into the same final feedingstuff
- the MFSp clearly states that when the two products are incorporated into the feedingstuff the longest withdrawal period applies
If a medicated feed also contains an SFA there is no legal requirement for the vet to include details of that SFA on the MFSp.
Supply relating to MFSp
It is the responsibility of the feed manufacturer or distributor to comply strictly with the terms of the MFSp. Where treatment lasts more than three months the vet (or in the case of an anthelmintic, the vet, pharmacist or SQP) must issue a new prescription.
A vet may only supply a veterinary medicine to a feedingstuffs manufacturer approved to use it. Exemptions to this are listed in the under the exemptions section.
Medicated feedingstuffs containing POM-V medicines can only be supplied to the keeper of animals on receipt of a written MFSp issued by a vet. However, they may be supplied to an approved Distributor without an MFSp.
If a MFSp is valid for a course of treatment lasting longer than one month, the keeper of animals may be supplied with enough veterinary medicine (or premixture containing a VMP) to fulfil that MFSp. However, only one month’s requirement of the medicated feed may be manufactured in each 31 day period.
A list of approved premises can be found on the Animal feedingstuffs registration page.
SFAs, premixtures and complementary feedingstuffs only containing SFAs do not need to be prescribed but they may only be supplied to appropriately approved or registered manufacturers or distributors.
Complete feedingstuffs containing only SFAs may be supplied without prescription to keepers of animals.
Record keeping relating to MFSp
An MFSp, including one produced electronically, must be kept for five years from the date the prescribing vet signed it.
An MFSp must be available immediately on request by an authorised inspector.
It’s the responsibility of the FeBO supplying a medicated feedingstuff to a farmer to keep the original MFSp. If the feedingstuffs manufacturer sells the medicated feedingstuff to an approved Distributor, there’s no legal requirement for the manufacturer to keep a copy of the MFSp. However, it is advisable for the manufacturer to ask for the feed order in writing or for a photocopy/fax of the MFSp to ensure that the correct feed is manufactured and supplied.
Manufacture of Medicated Feed subject to an MFSp
The MFSp must be strictly followed. If the quantity of medicated feed ordered exceeds the quantity prescribed, the feed supplier should advise the customer to discuss this with their vet. If the vet decides to increase the amount of feed prescribed they should instruct the feed manufacturer to amend their copy of the MFSp. This should be clearly recorded by the feed manufacturer.
It is an offence under the VMR to alter an MFSp without authorisation from the prescribing vet.
A feedingstuff containing a veterinary medicine may be prepared in anticipation of an MFSp. However, it cannot be supplied until the keeper of the animals is in possession of a valid MFSp.
A veterinary medicine which is authorised for incorporation into feedingstuff must be thoroughly mixed into the feedingstuff. Top dressing is only permitted where the product specifies this form of administration. In the absence of a suitable authorised product, a vet may wish to prescribe the product for off-label use under the cascade. It is the vet’s responsibility to ensure the correct dose is delivered and withdrawal period applied.
Withdrawal periods for Veterinary Medicinal Products prescribed under the Cascade
Information on the withdrawal periods for veterinary medicines prescribed under the cascade can be found in Schedule 4, paragraph 2 of the VMR.
Where more than one veterinary medicine is prescribed and all are used according to their SPCs then the longest withdrawal period applies.
Where more than one veterinary medicine is prescribed and one or more are used outside the terms and conditions of the SPC, then the statutory withdrawal periods set out in the VMR apply.
Importation of Feedingstuffs
For information on the importation of feedingstuffs containing a veterinary medicine refer to Schedule 5 paragraphs 27-29 of the VMR.
Containing Specified Feed Additives
From Member States
FeBOs may import EU community authorised feed additives and feedingstuffs containing them whose manufacture complies with EU community feed and food law from other MS.
From Third Countries
For information on the importation of feed additives and feedingstuffs containing them from third countries refer to article 23 of Regulation EC/183/2005.
For Export Only
For information on the export of feed additives and feedingstuffs containing them refer to article 12 of Regulation EC/178/2002.
Export of unauthorised substances or feed containing them
FeBOs must notify the VMD if they are exporting or re-exporting unauthorised medicinal substances intended for feed, unauthorised SFAs, or feed containing them to a third country (either directly or indirectly). This also applies to re-export of imported substances and when the unauthorised substance is incorporated into a premixture for export.
This notification must include all the details of the substances being exported, the details of the member states they will be moved through and the final destination. FeBOs must have the express consent from the final destination country prior to the export. If an alternative proof of authorisation of the substance is available then this will be acceptable. This should be retained for inspection by VMD.
It is an offence to possess a veterinary medicine, an SFA, a premixture containing either of these, or a feedingstuff containing either of these, or a complementary feedingstuff containing an SFA except in accordance with the VMR. However, possession of such products for exportation to third countries is allowed.
Inspectors appointed under the VMR may seize any veterinary medicine, or SFA that is not authorised in the UK, and any Schedule 5 product if it has not been lawfully manufactured, incorporated or supplied in accordance with the Regulations.
For more details on the seizure of products and appeals please refer to the Enforcement strategy for animal medicines.
Where an inspector identifies a non-compliance (deficiency) with the VMR in the FeBO’s operations, they will deal with the deficiency in accordance with the VMD’s Enforcement Strategy.
A FeBO served an Improvement Notice must take the appropriate remedial action within the specified timescale. Failure to comply is an offence that could lead to formal action being taken, including suspension or revocation of the FeBO approval and prosecution.
If an Improvement Notice is served, the VMD will charge the person on whom the Notice was served, the full economic cost of any subsequent inspection necessary to check that it has been complied with.
Disposal of feed products
The Environment Agency is responsible for the VMR relating to disposal of feed products. Guidance is available on the Environment agency webpage.
Additionally, local Waste Regulation Authorities can advise on the safe disposal of any unused product and empty containers. It is essential that any disposal be dealt with in accordance with the environmental legislation.
Who can sell what to whom
For a visual representation of who can sell products to whom please see.
Inspection of Feed Business Operators
The VMD inspects approved FeBOs to ensure they comply with the VMR.
Inspections are carried out on a risk basis; the higher the risk the more frequent the inspections. FeBOs are inspected at least every four years. The VMD will generally give a FeBO reasonable notice that they intend carrying out a routine inspection.
The Inspection Criteria is available from our Inspections Administration Team email@example.com and will be sent to a FeBO when it’s notified of an inspection.
Inspectors are authorised under the VMR to:
- inspect the premises, organisational arrangements and procedures used in the storage and distribution of Schedule 5 products
- interview key personnel named on the authorisation
- take samples
- examine any documentation or records relating to the manufacture, assembly, storage and distribution of Schedule 5 products
Following an inspection, the inspector will give the FeBO a report detailing any deficiencies (also referred to as non-compliances). For major and critical deficiencies, the inspector will request details of the measures that have been, or will be taken to correct them.
The VMD categorises deficiencies as critical, major and other (minor).
Minor (Other) Deficiencies:
- minor and poses no potential risk to human or animal health, or the environment
- does not indicate a significant deviation from the requirements of the VMR or Guidance
- cannot be classified as either critical or major because there is insufficient information to classify it as such
- non-critical but has produced, or has the potential to produce, a possible risk to human or animal health or the environment
- a major deviation from the requirements of the VMR
- a failure to carry out satisfactory procedures to ensure that products are manufactured, stored or distributed in accordance with their specific requirements
- a combination of more than six other (minor) deficiencies, none of which on their own may be major, but which may together represent a major deficiency and should be explained and reported as such
- other (minor) deficiencies that have been brought to the attention of the business on previous occasions but have not been resolved
- deficiencies that have produced, or have the potential to produce, a significant risk to human or animal health, or the environment
- a significant deviation from the requirements of the VMR through serious negligence or intent
Inspections are scheduled at intervals based on the number and type of deficiencies noted during an inspection, as follows:
|Inspection findings||Compliance category||Inspection Points*||Max inspection interval (months)|
|1, 2, 3||4, 5||6, 6F, 7, 8|
|0 deficiencies; recommendations only||5||0||24||36||48|
|1-6 minor (other)||4||1-6||24||36||48|
|More than 6 minors and / or 1-3 Majors||3||7-21||18||27||36|
|3 Majors plus 1 or more minors up to and including 5 Majors||2||22-35||12||18||24|
|More than 5 Majors and / or any Critical||1||36 and over||Follow up inspection as specified on Improvement Notice, then next inspection in 9 to 12 months|
*A minor deficiency = 1 point, a Major deficiency = 7 points and a Critical deficiency = 36 points
For the most serious deficiencies or failure to comply with the VMR, we may take formal action in accordance with our Enforcement Strategy. If we decide to suspend or revoke an approval, retailers have the right to appeal against that decision.
The VMD Legislation team via the VMD switchboard on 01932 336911. Please quote “medicated feedingstuffs”. Alternatively, email firstname.lastname@example.org.