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Appointed officers have full Marine Enforcement Officer (MEO) powers, but are restricted to enforcing the legislation specified within this schedule and can only exercise MEO enforcement powers within the jurisdiction specified in the counterparts to their warrant.
Updated: Guidence reviewed and updated
You need an Animal Test Certificate (ATC) to carry out the veterinary field trial of a medicine.
EU Directive 2001/82 defines a veterinary medicinal product as:
(a) any substance or combination of substances presented as having properties for treating or preventing disease in animals; or
(b) any substance or combination of substances which may be used in or administered to animals with a view either to restoring, correcting or modifying physiological functions by exerting a pharmacological, immunological or metabolic action, or to making a medical diagnosis.
The medicine(s) used during a veterinary field trial might include a veterinary medicine under development and/or an authorised human or veterinary medicine.
You must submit an application for an ATC to the VMD.
An ATC permits:
There are two types of Animal Test Certificate; an ATC and an ATC-S.
Pharmaceutical companies and veterinary researchers that want to conduct a veterinary field trial to generate data to support a marketing authorisation (MA) application require an ATC.
An ATC may also be required by veterinary researchers wishing to conduct a non-commercial clinical trial of a product that does not meet the criteria for an ATC-S.
| Q.1 | Is the product authorised as a human or veterinary medicine in the EU or EEA? | Yes go to Q.2 | No = Type B |
| Q.2 | Is the product: an immunological / biological product? | Yes go to Q.4 | No go to Q.3 |
| Q.3 | Is the medicine a pharmaceutical product? | Go to Q.5 | |
| Q.4 | Is the trial to be conducted in the species included in the existing MA? | Yes = Type A | No = Type B |
| Q.5 | Is the trial to be conducted exclusively in companion animals? | Yes = Type A | No go to Q.6 |
| Q.6 | Is the trial to be conducted in the authorised food species using the authorised dosage regimen (or lower), and using the same method of administration? | Yes = Type A | No = Type B |
The Type A procedure is used where the product is already authorised as a human or veterinary medicine in the EU or EEA and one of the following applies:
The Type B procedure should be used where the product does not meet the criteria set out under Type A.
Applicants for an ATC will be required to confirm that the trial will be carried out in accordance with the International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH) Topic 9: Guideline on Good Clinical Practices.
You will require this type of certificate if you are a researcher or practising vet and you want to carry out a small-scale non-commercial trial. These trials investigate the safety and/or efficacy of a human or veterinary medicine authorised in the EU, EEA, USA, Canada, Japan, New Zealand or Australia.
As small-scale non-commercial trials these will usually involve no more than 50 animals. However, you may use more than 50 animals where this is justified to permit meaningful statistical analyses. Before initiating your trial, you should contact the MA holder of the product under investigation.
Where possible, veterinary field trials conducted under an ATC-S should be conducted in accordance with Good Clinical Practice (GCP). As these trials are specifically intended for small scale non-commercial research trials conducted by vets, this may not be possible in all situations. To ensure robust study design and appropriate consideration of how to reduce, refine and replace the use of animals, the work should be subjected to an ethical review and conducted to recognised quality standards for published research, such as the Defra Joint Code of Practice for Research (JCoPR). On completion of the trial it is expected that the results will be reported in compliance with the principles set out in the Animal Research: Reporting In Vivo Experiments (ARRIVE) Guidelines.
For immunological products: if you wish to use an immunological product that is not the subject of a valid MA in the EU or EEA, contact the VMD before submitting an application under the ATC S application procedure.
For pharmaceutical products: researchers or practising vets who want to carry out small-scale non-commercial trials may occasionally need to apply for an ATC using the type B procedure. Therefore, to conduct a small-scale, non-commercial veterinary field trial of a medicine either an ATC-S or an ATC (Type B) application procedure is required. Use the following tables to determine the required application procedure.
| Q.1 | Is the product authorised as a human or veterinary medicine in: the EU (incl. UK), EEA, the United States, Canada, Japan, New Zealand, or Australia? | Yes go to Q.2 | No = ATC (Type B) |
| Q.2 | Is there published literature supporting the safety^1 and efficacy of the active substance(s) in this target species for the proposed indications and using the proposed dosage regimen? | Yes = ATC-S | No = Data unlikely to be sufficient to support an ATC-S application^2. |
1: If the product is a veterinary medicine to be administered to the authorised species using the authorised dosage regimen (or lower) additional safety data will not usually be required.
2: Refer to submission guidance and Annex 2 of the ATC-S application form for further information on the data requirements for target species safety and efficacy.
| Q.1 | Is the product a human or veterinary medicine authorised in the EU (incl. UK) or EEA? | Yes go to Q.2 | No = ATC (Type B) |
| Q.2 | Is the product a veterinary medicine to be used in the authorised species, using the authorised dosage regimen (or lower), and observing the withdrawal periods in the SPC? | Yes go to Q.6 | No go to Q.3 |
| Q.3 | Are the pharmacologically active substances in the product listed in Table 1 of the Annex to Commission regulations 37/2010? | Yes go to Q.4 | No go to Q.5 |
| Q.4 | Will the statutory or label withdrawal period (whichever is highest) be applied? | Yes go to Q.6 | No go to Q.5 |
| Q.5 | Is the medicine to be used for the treatment of horses, are the active substances listed as ‘essential for the treatment of equidae’ according to regulation (EC) 122/2013, and will a 6 month withdrawal period be applied? | Yes go to Q.6 | No = ATC (Type B) |
| Q.6 | Is there published literature supporting the safety^1 and efficacy of the active substance(s) in this target species for the proposed indications and using the proposed dosage regimen? | Yes = ATC-S | No = Data unlikely to be sufficient to support an ATC S application^2 . |
1: If the product is a veterinary medicine to be administered to the authorised species using the authorised dosage regimen (or lower) additional safety data will not usually be required.
2: Refer to submission guidance and Annex 2 of the ATC S application form for further information on the data requirements for target species safety and efficacy.
The VMD will conduct a benefit risk assessment based on the data submitted with each application in order to determine whether an ATC can be granted. In addition, the VMD will require confirmation that veterinary field trial protocols are to be conducted in compliance with GCP. You must also ensure your trial will be conducted in compliance with UK animal welfare legislation.
A veterinary field trial is conducted to evaluate the safety and/or efficacy of a medicine under conditions of field use, and will usually be conducted in client-owned animals. The evaluation of field safety and/or efficacy may include the taking of a blood sample prior to the administration of a medicine to establish a baseline for parameters. It may also include additional sampling at key points after administration of the medicine to monitor these parameters, where this is clinically justified.
It is anticipated that animals treated during a veterinary field trial with the product under investigation will be compared with a control group. Therefore, the veterinary field trial may include either:
The VMD assessment of each application will focus in particular on the risks associated with the proposed trial and will evaluate whether adequate safeguards are in place to ensure the safety of the following:
For more information on the ATC application process (e.g. data requirements and timescales), please refer to the guidance.
Each veterinary field trial requires a separate ATC and should normally only investigate one therapeutic indication in a single species. Exceptions to this include trials of ectoparasiticides, endectocides, or multivalent vaccines.
A trial may involve more than one product if:
A veterinary field trial involving a non medicinal therapy does not require an ATC. For example, the trial of a food supplement (nutraceutical) that is not a medicine, or the trial of a surgical intervention.
A veterinary field trial carried out by a vet who will administer a medicine in accordance with the provisions of the prescribing ‘cascade’ or a veterinary medicinal product in accordance with its Summary of Product Characteristics (SPC) may not require an ATC. Examples of when an ATC would be required include those cases where:
Studies licensed in full by the Home Office under the Animals (Scientific Procedures) Act 1986, including laboratory studies, do not require an ATC if they are conducted in a non food species or in animals that have been declared as not to enter the food chain. However, you must apply for an ATC if you intend for the produce from treated animals to enter the food chain and study animals will be treated with a medicine that is not authorised for use in that target species at the proposed dose (or above).
The retrospective analysis of clinical observations is not a veterinary field trial and does not require an ATC.
You can find more information on ‘the cascade’ by referring to the following guidance: The Cascade: Prescribing unauthorised medicines. Further information on how the Home Office regulates the use of animals in research can be obtained from the Home Office Animals (Scientific Procedures) Inspectorate.
An ATC is initially valid for a period of two years following approval. In most cases the authorised trial will be completed within this period. However, if the trial will still be in progress at the end of its period of validity you must renew the ATC to allow the trial to continue. If you wish to make any changes to the terms or conditions of an ATC you must do this by means of a variation application, unless otherwise agreed by the VMD.
For more information on the renewal or variation of an ATC please refer to the following guidance
While the ATC remains valid, if evidence becomes available which casts doubt on the safety, quality or efficacy of the product(s) involved, or alters the benefit risk assessment, the VMD may revoke, suspend or compulsorily vary the certificate. If the VMD becomes aware that an ATC holder has changed any of the approved specifications of the ATC without the prior approval of the VMD, the ATC will be suspended immediately. The suspension will remain in force until the changes have been approved, or the product is brought into line with the terms and conditions of the certificate.
You are responsible for reporting adverse events to the VMD and must name a person responsible for pharmacovigilance in your application. This person, usually a vet, must have overall responsibility for investigating any suspected adverse events, monitoring them and, when necessary, reporting them to the VMD. You should ensure that study investigators notify them if serious adverse events occur. You should also put in place appropriate arrangements to ensure that ‘blinding’ of products does not interfere with pharmacovigilance responsibilities.
Any serious adverse events to any substance used under an ATC which results in:
including suspected lack of efficacy, must be reported to the VMD within 15 days. For further information on reporting adverse events, see the Veterinary Pharmacovigilance: your responsibilities page.
You should keep appropriate records of adverse events that may occur following administration of the medicine, control or placebo including those which are not serious. A summary of all adverse events that occur during the trial will be required if the ATC is to be renewed. For studies conducted under GCP the study protocol should include procedures for observing, recording and reporting adverse events.
Updated: Household energy efficiency statistics October 2018 published.
This series presents statistics on the Energy Company Obligation (ECO) and Green Deal (GD). It incorporates changes as set out in response to the user consultation of National Statistics on the Green Deal, Energy Company Obligation and Insulation statistics. The headline releases present monthly updates of ECO measures and quarterly updates of in-depth ECO statistics, carbon savings and the Green Deal schemes. The detailed report presents annual updates on in-depth Green Deal statistics and insulation levels.
Historical releases are available on the National Archives.
Updated: Added statistical notice on changes in January 2018.
This section documents significant changes to the statistics either as a result of changes to the underlying administrative data system or changes made following user feedback.
Updated: List of host plants susceptible to Xylella fastidiosa in the EU updated
This section was updated on 21 August 2018.
Defra has introduced legislation, which came into force on Tuesday 21 August 2018, to protect oak trees against the imminent danger of introducing Thaumetopoea processionea (oak processionary moth-OPM) into the OPM Protected Zone through import and movement – http://www.legislation.gov.uk/uksi/2018/910/contents/made.
has now been published.
The legislation applies to oak trees (Quercus L), other than Q. suber, with a girth at 1.2m above the root collar of 8cm or more. Such trees represent the greatest likelihood of introducing OPM, hence the need for strengthened requirements. Existing requirements on OPM freedom continue to apply for trees with a smaller girth than 8cm.
The legislation prohibits the movement of plants into the OPM protected zone unless specific conditions are met. The legislation requires that imports into and movements within the OPM protected zone can only take place if the oak trees concerned:
The action has been taken following a recent interception in trade of OPM.
OPM caterpillars cause significant damage to oak trees and can pose risks to human and animal health. The Forestry Commission has operated an OPM Control Programme since 2013. As part of this Defra has set policies and control restrictions on the import and movement of oak trees to limit the spread of OPM.
OPM is an established pest in London and surrounding areas, but the majority of the UK is designated a Protected Zone and we have strengthened protection to mitigate the risk of introducing OPM into the UK OPM Protected Zone.
This section was added on 21 May 2018.
A new Commission Implementing Decision 2018/638 has been published establishing emergency measures to prevent the introduction into and spread within the EU of the harmful organism Spodoptera frugiperda (the fall armyworm).
This pest originated in the Americas and has become a major pest in parts of Africa.
The measures involve new requirements for Capsicum, Momordica and Solanum melongena and extends import controls to fruits of Solanum aethiopicum L., Solanum macrocarpon L. (both types of aubergine), and plants other than live pollen, plant tissue cultures, seeds and grains, of Zea mays (maize and sweetcorn) originating in Africa or in the Americas.
From 1 June 2018, a phytosanitary certificate will be required and advanced notification on PEACH to import this material from these countries.
This section was updated on 8 August 2018.
Xylella fastidiosa, a bacterial disease, represents a serious threat to plants in the UK. We are working to stop the spread of this disease and plant health authorities in the UK and elsewhere are keeping a close watch for it
Xylella has not yet been found in the UK, but it has recently affected olive trees in Italy, and a range of trees and plants in areas of Spain and France. Plants in North and South America are being damaged by the disease.
Everyone in a horticultural business, or who moves or imports affected plants, must comply with strict conditions imposed under EU legislation. These affect ‘specified plants’ (which includes the confirmed hosts of Xylella fastidiosa in the EU and further afield). There are:
Find out more about the controls:
This section was added on 11 January 2018.
All importers of fresh fruit and vegetables should be aware that EU Directive 2017/1279 has been published. This amends the EU Plant Health Directive 2000/29/EC and requires new additional declarations for:
See the Directive amendment for further detail.
This section was updated on 23 January 2018.
All importers of fresh fruit and vegetables should be aware that EU Directive 2017/1279 has been published. This amends the EU Plant Health Directive 2000/29/EC and will require tomatoes originating from all third countries (outside the EU but including Canary Islands, Ceuta, Melilla and the French Overseas Departments) and pomegranates originating from countries of the African continent, Cape Verde, Saint Helena, Madagascar, La Reunion, Mauritius and Israel to be imported with a phytosanitary certificate.
As an interim measure, while the Procedure for Electronic Application for Certificates (PEACH) online system is amended to accommodate this change, phytosanitary certificates for tomatoes and pomegranates should be emailed to Phyto-Heathrow@apha.gsi.gov.uk. Notifications to the Horticultural Marketing Inspectorate (HMI) , through PEACH should continue as normal.
From 8 February 2018, importers should make entries for this material on PEACH and upload copies of the physanitary certificates that accompany the applications. This will be in line with the process for other controlled commodities.
This Directive has been introduced with a view to protecting plants, plant products and other objects, in light of increased international trade and following pest risk assessments published by the European and Mediterranean Plant Protection Organisation. These risk assessments provided justification for adding tomatoes and pomegranates to the list of controlled material in Annex 5B (regulated material requiring a phytosanitary certificate) of Directive 2000/29/EC following the addition of 3 new harmful organisms to those listed in Annex 1 (prohibited pests):
We are appealing for palm growers, importers and retailers to be on the lookout for the red palm weevil, a threat to palm trees, which was identified in the UK for the first time in October 2016. It was found inside a round-leaf fountain palm imported from Italy, which had been purchased in Essex. The infested plant was destroyed.
APHA inspectors have surveyed susceptible palm trees within 10km of the affected tree and found no further signs of it. Tracing work has been carried out to locate and inspect material which was sent to other retailers and no further finds have been made to date.
We are appealing to the trade to look out for signs of the red palm weevil over the coming months and to source material carefully to avoid importing unwanted pests such as this into the UK.
The red palm weevil does not pose any risk to people, pets or livestock but is known to attack and kill a large range of palm species popular in the UK. The pest is native to Asia but was accidently introduced to Spain in 1994 and since then it has spread widely in the Mediterranean region where it has devastated ornamental palms, particularly the Canary Island date palm. It is known to affect palm species including Butia, Chamaerops, Phoenix, Saribus (=Livistona) Trachycarpus and Washingtonia
Weevils do not survive the winter however the larvae can. Larvae are legless, about 50 mm long, with a creamy-white body and reddish-brown head. Adult weevils are not expected to emerge until June. They are about 35mm long, with a characteristic long curved extension to the front of the head called a rostrum.
Larvae complete their lifecycle inside the palm, forming galleries as they tunnel their way through the trunk and bases of palm fronds. Adult beetles are most likely to be seen in the UK from June-September when summer temperatures are highest.
Larvae, pupae, pupal cases, and adults, can be found in the dead or dying crown of the palm or infested fronds. In heavily infested palms fallen empty pupal cases and dead adults may be found around the base of the palm. Early infestations or low numbers of the weevil in plants are very difficult to detect. The older leaves of a palm begin to droop during the early stages of infestation but quickly collapse. Later stages or large infestations cause a decreased size and yellowing of the frond, particularly the new fronds as the larvae destroy the growing point of the palm. Eventually the frond canopy becomes very small and distorted relative to the trunk and the crown dies.
Suspect findings of the red palm weevil should be reported to APHA’s Plant Health and Seeds Inspectorate by telephone 01904 405138 or by email planthealth.info@apha.gsi.gov.uk.
The government is committed to doing everything possible to prevent plant pests and diseases crossing our borders and, although we cannot eliminate all risks, we have stringent plans to deal with threats and take prompt action when they are detected. The government continues to work closely with the international community, industry, NGOs, landowners and the public to reduce the risks of pests and diseases entering the country, and to mitigate the impact of newly established ones.
This section was updated on 27 March 2018.
Since sweet chestnut blight was confirmed in trees in 2016, there have been cases at:
In all cases action was taken to limit spread of the disease from sites and determine its local distribution.
Further action will be taken on the basis of surveillance information and the best available scientific evidence. Local businesses or woodland owners and managers needing further information can contact their Forestry Commission Area office.
Following the outbreak in Devon in December 2016, a prohibition was imposed on the movement of oak and sweet chestnut material, including plants, logs, bark, branches, foliage and firewood out of, or within, 6 zones. 5 of these zones were in Devon and 1 in Dorset.
The prohibitions in all 6 zones took effect on Friday 12 May 2017 and were lifted on Tuesday 27 March 2018.
Movement restrictions at affected sites where infected trees were found will continue on a site by site basis taking account of the situation in each area based on the current policy approach.
The requirements of the prohibition were intended to reflect a precautionary approach to protect against the risk of spread of infected material. Since finding the disease in late 2016 intelligence has been gathered and extensive research conducted to improve understanding of the disease risk. In the majority of sites in south-west England there has been no evidence of spread to the wider environment.
See the notice relating to the lifting of the movement prohibition:
Local woodland and business owners and managers who need further information about the lifting of the movement prohibition may contact the Forestry Commission’s South-West England Area office by email southwest.fce@forestry.gsi.gov.uk or by telephone on 0300 067 4960.
The horticulture trade, garden centres and householders should contact the PHSI on 01904 405138 or planthealth.info@apha.gsi.gov.uk.
This section was updated on 23 February 2018.
Brown rot is a damaging disease of potatoes spread by infected potatoes and by contaminated water.
APHA carries out the annual surveillance programme in England, including watercourses in areas where potatoes are commonly grown.
When a finding is confirmed in water, the watercourse concerned must be officially designated and irrigation restrictions imposed for potato and tomato crops. Irrigation of other crops is not affected.
As a result of the 2016 surveillance programme, 2 watercourses in the Middle Level of the Cambridgeshire Fens have been confirmed as contaminated.
APHA and Defra have been working with national and stakeholder organisations, as well as with individual growers in the area, to ensure that affected potato growers are informed of the consequences and aware of their options for irrigating in future. This included hosting a stakeholder event held in March, Cambridgeshire, which around 50 growers and industry representatives attended.
Other growers in the Middle Level have also been informed of developments and following surveillance in 2017 a limited number of additional watercourses have been confirmed contaminated requiring an extension to existing statutory notices.
Under the provisions of the Plant Health (England) Order 2015, an APHA Notice will demarcate the areas under which restrictions will apply (20km from contaminated watercourses), while a Ministerial Notice will describe the restrictions themselves. These provisions supplement the general provisions of the Order, which prohibit the movement of harmful organisms, such as the pathogen causing potato brown rot.
The Notices will take effect on 21 February 2018.
Fresh curry leaves can only be imported from countries able to fulfil the requirements of the EU import regulations. This includes the need to originate from countries recognised as free of citrus greening disease. Currently there are no countries that have satisfied this requirement and so fresh curry leaves are not permitted to be imported into the EU. If curry leaves are imported they must be either frozen or dried at time of import.
In August 2014 the Russian Federation introduced a ban on the import of some agricultural commodities from the whole of the EU including the UK. This includes fruit and vegetables.
The Russian Federation had extended the ban to August 2016, but the ban is now on-going.
If you are exporting products to the Russian Federation from the UK, which were originally from outside the EU, you are advised to request a phytosanitary certificate from the original country’s plant health authority before exporting the consignment to the EU – even if your product does not need a certificate to enter the EU.
The certificate can then accompany your consignment, with any other documents, to prove the origin of the products.