The Applicant Guide: Application Fees Guidance
The UK has left the EU, new rules from January 2021
The transition period after Brexit comes to an end this year.
Why are fees charged?
We charge fees to ensure that the full economic costs of evaluating and processing applications are recovered. Each year we review the costs of the work (using detailed work recording data), and following consultation with applicants and authorisation holders, we set the fees for the next year.
What is the legal basis for charging this fee?
The legislative basis for (and level of) the application fees is given under The Plant Protection Product (Fees and Charges) Regulations 2011.
What is the Annual Charge?
The application fees recover the cost of handling applications but the costs for work involved in reviewing and monitoring pesticides are met via an 'annual charge'. This is based on the turnover on UK sales of all commercially authorised plant protection products. Each year we write to authorisation holders and ask them to provide details of their sales figures (for plant protection products authorised under both national rules and EU rules). The annual charge is expressed as a percentage of the declared sales turnover, and each year authorisation holders are invoiced for the appropriate amount. If you want to find out more about the annual charge, how it is calculated and how it should be paid, you should contact [email protected].
What fee will be charged for my application?
There are a range of different application fees , which reflect the evaluation work involved in processing applications, and other regulatory work that we conduct. If you are submitting an application for an import tolerance or to gain official recognition for an efficacy testing organisation, specific fees apply. Please note that the sift fee also applies to these types of application. Applications for the consideration of adverse data, for the official listing of adjuvants and for certificates of free sale are free of charge. We have included some detail below as to when each fee will apply and from this you should be able to estimate the fee that will be charged in advance of submitting your application.
When will the fee be charged?
In general the invoice will be issued in full once an application has been accepted by the applications sift. Applicants are asked not to send cheques in with application and to respond to the invoices issued instead. All invoices must be paid in full before any authorisations or permits can be issued .
How much will an application cost when it is for a new active substance or an EU Review?
New active substances and EU reviews are charged using a modular fee system. Each 'module' of work attracts a separate fee, and the total fee is the sum of each of those separate charges. Whether or not a module applies to your submission depends on the type of evaluation and the areas of input required. Since not all modules can be progressed simultaneously, you will be invoiced as each major step of the evaluation process is due to start.
For example, in the case where the UK is acting as rapporteur for approval of a new active substance under Regulation (EC) 1107/2009, you will first receive an invoice for the completeness check. Assuming the dossier is accepted as ready for detailed evaluation, you will then be sent a second invoice for the fee to evaluate the dossier; and once the draft assessment report was ready for submission to EFSA for peer review, you will be sent a further invoice to cover the cost of the peer review work.
If at any stage during the detailed evaluation or the EFSA peer review, issues are identified, which need to be resolved by the submission of further data then you will be invoiced for a further fee to cover the costs of evaluating the additional data. To help you decide which of the modules will apply for your application, see below:
- The "completeness check" fee covers the cost of checking the completeness of a full dossier submitted either to support the first approval of a new or existing active substance under Regulation (EC) 1107/2009.
- The fee for the evaluation of a "core dossier" covers the cost of the detailed evaluation of a full dossier intended to support the use of a single formulated product on one major representative crop. It is also based on the assumption that dossiers do not contain extensive data packages for environmental or plant metabolites.
- The fee for the evaluation of a "partial dossier" covers the cost of the detailed evaluation of:
- Joint evaluation where we will evaluate part of a core dossier and the remainder of the dossier is evaluated by the competent authorities of one or more other member states.
- Additional data over and above a 'standard' core dossier for example situations where there are significantly more metabolites, or very large novel studies to be evaluated.
- Additional study submissions during evaluation required to clarify the initial dossier.
- Resubmissions ie where the previous application for approval or Annex 1 inclusion has been unsuccessful and a new application is made in an attempt to address all the concerns raised from that earlier submission
- Data to support the extension of the approval under Regulation (EC) 1107/2009 once the initial inclusion period of 10 years has expired; or to change the conditions of the approval during the approval period.
- Data to support the evaluation of an active substance renewal dossier under Regulation (EC) 1107/2009 once the initial period of approval has expired ie with no full dossier, just additional data to fill new guidance, regulations and scientific advances.
- Fees for the evaluation of dossiers on biopesticides and pheromones are lower than those for 'conventional' plant protection products. Furthermore, there is no separate fee for the completeness check or for processing the first application for product authorisation.
- The "EFSA peer review fee" applies where the UK is rapporteur member state with respect to the approval of a new active substance under Regulation (EC) 1107/2009. (For biopesticides and pheromones, a lower fee is charged for this work)
- The co-rapporteur fee applies when a company requests the UK to act as co-rapporteur, by assisting another MS during the EFSA peer review process for a new or existing active substance.
- The "Review of another member state draft assessment report" fee applies for existing active substances, for which another member state is acting as Rapporteur with respect to the approval of that active substance under Regulation (EC) 1107/2009.
How much will a product application cost?
Product applications are charged using a modular fee system. Each 'module' of work attracts a separate fee, and the total fee is the sum of each of those separate charges. Whether or not a module applies to your submission depends on the type of application you are submitting and the areas of input required. To help you decide which of the modules will apply for your application, see below:
- The sift fee applies to all applications, except for extensions of use and Administrative Trials Permit applications. The fee covers the initial checking of the submission at the weekly sift.
- A co-ordination fee is applied to the different application types where technical assessment is required.
- The Administrative Trials Permit fee applies only to applications for a Trials permit requiring no technical input. No other fees will be applied to this type of application.
- The off-label fee covers all aspects of the evaluation of an application for extension of Authorisation for a minor use, and no other fees apply.
- The administrative application fee is used for applications involving no technical input (and own-use parallel imports).
- For parallel import applications a co-ordination fee will be charged in all cases and, where necessary, an additional verification fee will also be charged.
- For any applications where a technical input is required (including Mutual Recognition and Trials Permits), the co-ordination fee and sift fee will be applied, along with a varying number and type of the specialist evaluation fees. These will be determined by the type of evaluation that is required and the data you provide.
- The specialist evaluation fees cover the evaluation of data or a case in each of the specialist areas (active/product chemistry; toxicology; residues/consumer exposure; operator exposure; ecotoxicology; fate and behaviour; efficacy and crop safety). Either the case fee or data fee will be charged in each area, but not both.
- The label check fee applies whenever a label is submitted.
The advice above will help you to understand how the fees are applied but if you are unsure about charging, you should contact us.
When will I be informed of the fee?
Following consideration and acceptance of your submission at the sift, you will be sent an invoice which details all of the fees and the total amount required for the application.
Where an application is subject to a detailed technical sift, the fees required will be applied in stages reflecting the validation check, detailed technical sift, and evaluation stage, although only one invoice will be issued.
Additional fees may also be applied mid evaluation where additional data is required and accepted, although only one invoice will be issued.
Information on applications subject to a detailed sift is available under ‘The Applicant Guide: How Will My Application Be Processed?’
Can I submit payment with my application
Payment should not be sent with the application. An invoice will be issued once the application has been accepted.
Do I get a refund if I withdraw my application?
If you want to withdraw an application, you should contact the Evaluating Officer or project manager for your application at the earliest opportunity.
For product applications charged under the modular fee system, and where no work has been carried out other than the sift, we will refund the fee, minus the sift fee and an administration charge (the withdrawal fee). Where work has started on the evaluation, a refund is not usually possible, although we will consider refunds of 'unstarted' modules of work. In this circumstance, you should contact the Evaluating Officer for advice.
For new active substance and EU review, if the application is withdrawn before evaluation starts, the evaluation fee will not be charged, but the completeness check fee will not be refunded.
How do I pay the fee?
Payment can be made by cheque (payable to Health and Safety Executive) or BACS. Full payment details can be found on the invoice.
What happens if I do not pay the fee?
No authorisation will be issued until full payment is made, and we will adopt full debt recovery procedures for all unpaid fees. Payment is required even in the circumstance that authorisation is refused. If we have not received payment 30 days after the invoice has been issued, we will contact you to remind you that payment is due.