Top tips for making a claim

1. You should make sure you sign and date your claim form. It should not be signed by agents or anyone who has helped you fill out the form. If you don’t sign the form it will be returned and payments will be delayed.

2. You should make sure the items you are claiming match the items listed on the offer letter. If they do not then you must contact the Marine Management Organisation (MMO) to discuss any changes.

3. You should make sure that any increases in costs being claimed or any other changes to your project have been approved by MMO in writing before you make your claim – this includes changes to suppliers. If the changes are not approved there is a risk that you will not receive your entire claim. Changes are things like additional unforeseen works, changes in costs due to increases in the cost of materials such as wood and steel.

4. You must supply original invoices or an email that you have received direct from the supplier with the invoice attached.

5. Provide a suitable audit trail to show how the invoice was paid either by cheque, bacs or faster payment, preferably in the form of a bank statement or online banking screen print. Cash payments are not acceptable as you cannot provide adequate evidence to support a cash payment.

6. Your payment will be delayed if you don’t send in all of the necessary information MMO needs to process your claim.

7. You must tell MMO as soon as possible if you will miss your claim date – this is in the claims schedule in your offer letter. If you need to change the claim schedule please submit a Notification of Change request via the e-system. The MMO will try and contact you if you go past your claim date but if we can’t get in touch with you, you could risk having your funding withdrawn.

8. If you have any queries about your claim contact MMO for advice.

Submit a claim for EMFF funds

You will need to submit a claim online in order to get your EMFF funds. Items purchased and claimed must be from the supplier stated in your offer letter and work must have started after you were sent confirmation that the MMO acknowledged your application. This date is in the offer letter. Any invoices dated prior to that date will be deemed ineligible and you will not be paid any grant money against those invoices.

You will only be able to claim once you have paid for all or some of the items outlined in your EMFF offer letter. You will need to provide evidence that you have done this when you submit your claim form. This evidence must be an invoice accompanied by proof that you have paid after the invoice was received, for example a bank statement.

Please make sure you fill in a SOP 7 form with your bank details so we can pay your funds to you. This form will be emailed to you with your offer letter. Once you have completed the form it needs to be emailed to emff.queries@marinemanagement.org.uk to enable your bank details to be set up on our payments system. If you have more than 1 project approved you only need to complete 1 SOP 7 form.

Claiming your grant money

The MMO will only pay you your grant money in arrears – you need to prove you’ve spent your money on the item or service by completing the online claim form in the e-system.

You will need to submit:

• dated invoices (example invoice) which show the amount of money you paid for each product or service you’re claiming
• proof of payment eg a bank statement
• a progress update on your project if it is required. See your offer letter for the progress report schedule

The MMO can decline to pay you part of the grant, or the whole grant, if we don’t think the information on your invoices is accurate, or the products or services you bought aren’t what was approved.

The conditions in your offer letter will explain about what you must do and the information you must send to get your grant paid.

Costs you can’t claim for

You must not claim EMFF grant money for the following:

• to pay interest on a debt
• to buy land or housing that’s worth more than 10% of your project’s total expenditure
• to pay your business’s operating costs, unless the MMO has told you otherwise
• if you have a loan on an item you have purchased you cannot claim for it until the loan is repaid
• any costs that you could recover in part or in total by making a claim on an insurance policy or by seeking compensation or damages

Reporting and inspections

Reporting your progress

You must give the MMO updates on your project as outlined in your offer letter which may be every 6 months, plus one performance report each year for the first 3 years. A reminder will be issued when these are due.

If you don’t carry out your project in accordance with the timetable in your offer letter, the MMO will ask you to explain the delay and any impact on your targets and benefits.

The MMO could then cancel your grant offer or change it depending on the reasons you give. Should this be the case a full explanation will be provided.

We may also decide to reclaim any funds you have already been paid.

The MMO can take criminal or civil action to reclaim any money we paid you if we find you gave false information in your application, or if you do any of the following:

• break the conditions in the grant offer letter
• use the money for a different purpose to what you said you’d use it for when you applied
• commit fraud

Inspections

You must let the MMO officials visit your vessel or other sites related to your project to check your progress and report it to the European Commission.

The following bodies can also inspect your project after you’ve been sent a grant offer letter:

• the National Audit Office
• the European Commission
• European Court Auditors
• any other agents deemed appropriate by the European Commission or MMO

They’ll usually give you at least 48 hours’ notice, but they don’t have to.

Reporting changes to your project

You usually need to apply to the MMO to change your project after you’ve signed and returned the offer letter, e.g. if you want to:

• change the make-up of your project matched funds
• increase or decrease the total cost of your entire project
• changes to the targets and benefits agreed in your offer letter
• use different contractors or suppliers to the ones agreed in your offer letter
• change the timetable of your project
• sell or dispose of any item of infrastructure purchased as part of your project
• stop any activity that’s part of your project
• change the location of the activity

You need to justify any changes by telling the MMO in your e-system account using a Notification of Change request.

If you change your project without telling the MMO, the MMO could cancel your grant award, change it or refuse to pay grant money for costs associated with the changes.

Any conditions in your offer letter apply for 5 years from the date your final claim is paid to you.

Retrospective amendments

Retrospective amendments cannot be considered. You must apply to the MMO to change your project before making changes including additional costs. If you modify your project without approval from the MMO the project or part of the project could be ineligible for payment.

Changing the cost of your project

If you increase the total cost of your project, the MMO will only pay you more grant money if we decide you couldn’t have predicted this increase when you were applying. You must contact us to discuss this as soon as you are aware of any changes in project costs.

If the total eligible costs of your project decrease, then so will the grant award.

Amendments where costs decrease

If you are making changes to your project that decreases your project costs and the targets and benefits will be delivered as planned you do not have to tell the MMO.

If you are making any changes to your project that decreases your project costs but the targets and benefits will not be delivered as planned you must inform the MMO as soon as possible so that options can be discussed.

Change of supplier

We understand that sometimes suppliers to your project have to change:

• if you need to change to a different supplier, if they supplied a quote on your original project application and the costs do not increase then you do not need to supply a new quote. If the costs have changed then you need to obtain a new quote from them and submit a change request form to MMO and get it approved before undertaking any changes
• if you need to change to a different supplier and they have not previously quoted even if the costs will remain the same you will need to obtain a new quote and submit a change request form to MMO and get it approved before undertaking any work.
• a rationale for all requested changes should be included in your Notification of change request.

Where a project is under the panel threshold and an amendment takes it over

Any project (whether approved by team assessment or panel) that has a cost increase of less than 10% of the total project cost can be assessed by team assessment. The MMO can choose to send any project decision or amendment to panel regardless of value if it is deemed necessary for reasons that can include but is not limited to complexity or risk to the EMFF fund.

Where a project was assessed by panel and the cost increase is greater than 10% of the total project cost the amendment must be assessed by panel at the next meeting or by written procedure if agreed. You will be informed by the MMO if this applies to you including the dates of the next panel.

If a number of amendments are received that collectively exceed 10% of the total project cost the MMO has the discretion to refer the requests to panel and to review the requests collectively. You will be informed if this decision is taken including the dates of the next panel.

Change to project manager within a company/project

If you have a change of project manager within your business or company you should inform the MMO in writing with the new contact details as soon as possible. If you don’t inform the MMO then it could result in your new project manager being unable to access or discuss the project.

Change of ownership

If you have had a project approved then you should not sell or dispose of any funded items of the project within 5 years of the date of the final grant payment. Consumables are exempt from this. (This is referred to as durability of operations).

If you sell or undertake any other action that changes the ownership of any funded item from the original applicant within the 5 years durability of operations the MMO must be informed in writing by you. This includes indirect changes e.g. where a premises or vessel on which the item is situated changes ownership.

It is your responsibility as the original applicant to inform the new owners of the funding obligations attached to the item. The new owners will be required to take on the terms and conditions of the grant for the time remaining up to 5 years of durability of operations. If the new owner of the item or items does not accept the terms and conditions of the funding then it is deemed that the item has not fulfilled its obligations to the scheme and therefore recovery proceedings may be started and funding recovered from you as the original applicant.

Declaring additional funding

If you apply for or receive a grant through another scheme, you must tell the:

• body that runs the other scheme that you’ve been accepted for EMFF funding
• MMO that you’ve been accepted for another grant

The MMO can decide that you’re no longer eligible for EMFF funding if you get money from another scheme, based on the:

• source of the money – you’ll be more likely to be ineligible for EMFF funding if you’ve got funding from another European Commission scheme
• amount of money you got from the other scheme
• conditions of the other grant

If you’re deemed ineligible, the MMO can take action to get money back from you, or cancel any payments that were due.

Moving your vessel outside the EU

You must not transfer a fishing vessel outside the EU for at least 5 years after spending EMFF grant money on it – if you do this you must give back part of the EMFF money you received.

The exact amount you have to pay back depends on when you transferred the vessel.

Records you must keep

If your application is successful, you must keep all documents related to your project for at least 5 years from the date of your last EMFF claim, including:

• licences
• consents
• quotes
• invoices
• receipts or other documents which record your spending
• all accounting documents related to your application
• claim forms

You must give the MMO or the European Commission any information or documents that they ask for at any stage.

The MMO may give your name and address to an independent person they’ve hired to evaluate your project.

You should also keep your project documentation under a separate accounting system or accounting code to ensure it is easily differentiated from your businesses other accounts and transactions.

Transparency Initiative

The MMO make public all beneficiaries of the grant aid from EMFF.

EMFF Transparency Initiative

MS Excel Spreadsheet, 151KB

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EMFF panel decisions

EMFF June 2016 panel decisions

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EMFF August 2016 panel decisions

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EMFF November 2016 panel decisions

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EMFF March 2017 panel decisions

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EMFF September 2017 panel decisions

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EMFF March 2018 panel decisions

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Contact us

Telephone: 0208 026 5539

Fax: 0191 376 2681

Email: emff.queries@marinemanagement.org.uk

Woking borough council would very much welcome your feedback on this proposed new approach. This is your opportunity to help refine the process before the pilot begins this spring.

The consultation is open until 5pm on Wednesday 10 February 2016.

To find out more about the proposed pilot and how you can comment, see Woking borough council’s consultation.

Background

The pilot scheme represents a milestone in Natural England’s drive to reform regulation. It will:

• make it easier for industry to observe environmental laws
• achieve more for the natural environment

It’s an exciting win-win opportunity that moves Natural England from tackling the challenges caused by great crested newts on development sites in a reactive site-by-site approach to one that’s proactive and genuinely strategic.

Natural England is confident this approach will secure long-term improvements to the conservation status of great crested newts in Woking borough. The pilot also seeks to establish a planning and licensing framework which could be adopted for other protected species and other areas of the country.

LLW Repository’s National Waste Programme Quarterly Reports show progress being made within the National Waste Programme community.

Find out more about the National Waste Programme; established to implement the UK LLW Strategy. An industry-wide collaboration led by LLWR on behalf of the NDA.

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.

When you need an Animal Test Certificate

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:

• the use of a veterinary medicine during a veterinary field trial, including outside of the terms of its marketing authorisation
• the procurement and supply of that medicine
• the import of any medicine specified in the certificate in accordance with the conditions of that certificate
• the produce from treated animals to enter the food chain if appropriate
• the use of randomisation and/or blinding within the study protocol
• the administration of a placebo product

Types of Animal Test Certificate

There are two types of Animal Test Certificate; an ATC and an ATC-S.

ATC:

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.

To obtain an ATC you must apply using the Type A or Type B application procedure:

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:

1. The medicine is a veterinary immunological product and the veterinary field trial is to be conducted in species included in the existing marketing authorisation.
2. The medicine is a pharmaceutical product and the trial is to be conducted in:

• 2a. companion animals, or
• 2b. a food-producing species and the dosing regimen to be tested is the same as (or lower than) the dosing regimen authorised for use in that species via the same route of administration.

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.

ATC-S:

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.

To obtain an ATC-S, you must apply using the ATC-S application procedure.

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.

Decision table for pharmaceutical products to be tested in non-food animals:

• companion animals
• horses declared never to enter the food chain
• other animals (or their products) declared to never enter the food chain

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.

Decision table for pharmaceutical products to be tested in food producing animals:

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 .

Hereafter the term ATC refers to all types of Animal Test Certificate (ATC and ATC-S).

Assessment of the application

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:

• a group of animals designated as positive controls and treated with either an existing medicine or an established procedure
• a group of animals designated as negative controls and treated with a placebo

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:

• animals participating in the trial
• those people using the medicines under investigation or handling treated animals
• consumers of produce from treated animals
• the environment (where applicable)

For more information on the ATC application process (e.g. data requirements and timescales), please refer to the guidance.

Number of trials and products per ATC

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:

• the second product is a placebo
• the second product is a positive control that is authorised in at least one EU or European Economic Area (EEA) Member State for administration to the same species for the same indication
• the second product is a human product, its use is well supported by literature references, and there is no suitable authorised veterinary medicine
• the products are of the same pharmaceutical form and contain the same ingredients, but they differ in the strength or dosage of the active or inactive ingredients
• the products are vaccines and differ only in the inclusion or exclusion of particular antigens under investigation
• the products are of two or more dilutions of either the same allergen extract or mixture of allergen extracts used for desensitisation therapy; or the products used for in-vivo diagnosis of an allergy are manufactured by the same method from closely related substances, e.g. pollen
• more than one product is expected to be required to produce therapeutic efficacy; for example, the administration of sedative or analgesic combinations, or allergens.

An ATC may not be required in certain cases:

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:

• the study design prevents the prescribing vet from using their professional judgement when making treatment decisions (e.g. due to randomisation)
• the medicines used during the field study will not be labelled in accordance with the VMR (e.g. to facilitate a ‘blinded’ study)

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.

Post authorisation steps

Validity of an ATC

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.

Pharmacovigilance

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:

• death or increased rates of death in a species for which there is an accepted death rate
• life-threatening clinical signs
• significant disability or incapacity
• congenital anomalies or birth defects
• permanent or prolonged signs
• a reaction involving a human

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.

Contact us

Email: postmaster@vmd.defra.gsi.gov.uk