What is a data submission deadline?
A data submission deadline (DSD) is a date by which confirmatory data requirements must be met to support continuing approval of a product or a Specific Off-Label approval (SOLA) for a specific product/use.
When are data submission deadlines set?
Under the Control of Pesticides Regulations (as amended) 1986 (COPR), we are able to grant provisional approvals for a fixed period with a view to outstanding (confirmatory) data requirements being satisfactorily addressed. A full approval will be issued if all data requirements have been satisfactorily addressed.
If your product receives a provisional approval, the Notice will specify the DSD by which you must submit an application to address the outstanding data requirements. DSDs are normally set for three years to allow time for necessary studies or trials to be carried out, though shorter deadlines may be specified depending on the nature of the data requirements. Occasionally, your product may have more than one DSD.
DSDs are not set for approvals issued under the Plant Protection Product Regulations 2005 (PPPR) since under the terms of Council Directive 91/414/EEC, all data requirements must be satisfactorily addressed before an approval can be granted. However, we may sometimes issue a time-limited standard approval (interim standard approval) where there is only a minor (and not safety) deficiency upon evaluation but otherwise all requirements have been met. You will need to submit an application to address these data gaps before the date of expiry specified on the approval. We will also issue provisional approvals under PPPR prior to a new active substance being included in Annex I, and for these we may identify open points that will need to be addressed prior to the product being granted a standard approval. There will be no formal DSD to address these open points.
What will happen to my approval if I meet a data submission deadline?
If you submit an application for full or continuing approval and this is accepted by the DSD, the approval for your product will continue until the data/information are evaluated and the application completed. If your application is successful, a new approval will be granted replacing the previous approval. Otherwise, if your application is not successful, we will take appropriate revocation action against the existing approval.
What will happen if I do not meet a data submission deadline?
If you fail to meet a DSD for your product you will lose approval for your product. If the DSD relates to specific uses of your product or claims on your product label, you will lose approval for those uses or label recommendations.
If you fail to meet a DSD for your SOLA then the approval will usually continue until the date of expiry specified on your SOLA. You may submit an application to address the data requirements after the DSD has passed but we cannot guarantee that we will be able to issue an approval before the date of expiry.
Will I be reminded of a data submission deadline?
On a monthly basis, we will identify all DSDs which occur in three months time, and for which applications to address the appropriate data requirements have not been submitted. If you have not met a DSD for your product, we will send you a letter to remind you that the DSD is approaching, and will outline the consequences of failing to submit an application to meet the DSD.
One month before the DSD we will contact you again if you have still not submitted an application to meet the DSD. We will confirm that revocation action will be taken for products if individual approval holders do not submit an application to meet the DSD.
If your approval is for a ‘parallel import’ you will be sent the same reminder letters at three months and one month before the DSD as we send to the approval holder for the UK master product.
What regulatory action will be taken if I fail to meet a data submission deadline?
If you fail to submit an application to meet a DSD the following action will be taken once the DSD has passed:
Product approval
Where the outstanding data (such as storage stability data) are required to support the continued approval for all uses, we will ‘part-revoke’ the approval for the product a few days after the deadline. This will allow stocks already in the supply chain to be used up (normally for a period of one year) but no further stocks may be placed in the supply chain from the date of revocation.
Use/container approval on a separate approval
Where the outstanding data apply only to a single use/crop/container type and that use/crop/container is specified on a separate provisional approval notice, we will ‘part-revoke’ that approval a few days after the deadline. This will allow stocks already in the supply chain to be used up (normally for a period of one year) but no further stocks relating to that use/crop/container may be placed in the supply chain from the date of revocation.
Any other uses/crops/containers which are approved on a separate notice of approval will continue. However you will be required to amend your labels to remove all reference to the unsupported use (or stop supplying the product in the unsupported container).
Uses/claims on the product approval
Where the outstanding data apply to a specific use or claim (such as control data for a specific pest) and the whole product is provisionally approved, we will ‘part-revoke’ the approval a few days after the deadline. This will allow stocks already in the supply chain to be used up (normally for a period of one year) but no further stocks may be placed in the supply chain from the date of revocation.
If you wish to maintain approval for the other uses (i.e. those not affected by the data requirement), you will need to submit an application to re-instate approval, omitting the unsupported use/claim. Such a request will be processed via the ‘Admin’ Stream (see The Applicant Guide for further information). The unsupported use/claim will be deleted from your new approval and a label amendment will be issued to delete all references to the unsupported use/claim.
In each case, failure to meet deadlines and the resultant regulatory action will be published on our website.
If I have an approval for a parallel import, what will happen if the data submission deadline is not met for the master product?
Any regulatory action taken as a result of failure to meet the DSD for the UK master product will also be applied to your parallel import approval.
How do I extend a data submission deadline?
If you wish to extend a data submission deadline you should submit an ‘Admin’ Stream application at least three months before the DSD. We can not guarantee that we can successfully evaluate an application for an extension to a DSD if it is submitted less than three months before the DSD. Further information can be found in the guidance for submitting applications via the 'Administrative' Stream.
How do I make an application for a new product when a data submission deadline has passed or is imminent for a related product?
If you wish to submit an application for approval of a new product, you should also consider whether any related products have an impending or recently passed DSD for data that are relevant to the approval for the new product. Related products can be considered as:
- Identical or similar products upon which the new product will be based; and,
- Products containing the same source of active substance; and,
- Products with different active substances but with other relevant data requirements e.g. for specific container types.
If your application is for approval of a new product which may be affected by an impending or recently passed DSD for a related product you will need to consider the following:
Data submission deadlines already met for related product
If an application to meet the DSD for the related product has been accepted, and you want an approval issued for your new product before this application is completed, you will need to submit two applications for your new product.
The first application will allow us to issue an approval for the new product. The second application will be linked to the ongoing application for the related product so that any regulatory action required after the completion of that application can be carried across to the new product.
The applications for the new product will be processed via the appropriate stream (see guidance document) and should include details of the ongoing application for the related product.
Alternatively, if you do not mind waiting for the application for the related product to be completed before your new product is approved, you need only submit one application for the new product. We will link this to the ongoing application for the related product and will issue an approval upon successful completion of the application for the related product.
Data submission deadline is imminent for related product
If a DSD is imminent for a related product but an application to meet the DSD has not yet been submitted and you submit an application for approval of a new product, we will accept and evaluate this application.
However, when an application is submitted to meet the DSD for the related product, you will also need to submit an application for the new product. This application will be evaluated at the same time as the one for the related product so that any regulatory action required after the completion of that application can be carried across to the new product.
If you fail to submit a second application for the new product we will take one of the following courses of action when the evaluation your ongoing application is completed:
- If the DSD for the related product has not passed, approval will be issued for the new product with the same DSD. If a second application for the new product is not subsequently submitted, approval for this product will be revoked at the DSD. If the DSD is within a short period of time, we will attempt to inform you as soon as possible so that you can submit an appropriate second application to allow the approval for your product to continue; or,
- If the DSD has passed and an application has already been submitted for the related product, approval will not be issued for the new product until a second application is submitted and accepted for it. You will be informed if a second application for the new product is required and will have four weeks to submit this application. If you do not submit the second application within this time, approval for the new product will be refused.
