Data requirements for continuing pesticide product authorisation

Overview

All data requirements must be satisfactorily addressed before a pesticide product authorisation can be granted.

The data requirements depend on application type based on the regulations 283/2013, 284/2013, 544/2011 and 545/2011.

We may sometimes issue a time-limited authorisation, where all data requirements have been met but where a minor, not safety, deficiency (such as storage stability of a specific container) has been identified at evaluation.

These data requirements will be listed in an appendix to the recommendations letter that accompanies the pesticide product authorisation.

Meeting data requirements

Data requirements may have been set when authorisation was first granted. You must address these requirements at least 52 weeks before the expiry date of the product to allow for a decision to be made before the expiry date, otherwise your authorisation will expire

HSE will evaluate the submitted information and reach a decision regarding extension of the product authorisation.

In a very few cases, a specific deadline by which the data must be submitted is specified on the authorisation, but the same principles apply. In these cases, failure to provide the information by the specified deadline is likely to result in withdrawal of the product authorisation.

For applications to address such data gaps:

• fully explain your request in a covering letter
• complete application form CRD1 - ensuring it’s signed and dated
• submit any letters of access to third party data that are required
• submit any previous relevant correspondence which must be, at a minimum, a reference to your product's authorisation (including COP number, date of issue and notice of authorisation number)
• if you wish us to consider your proposed product label, submit one copy of the proposed product label and, if necessary, a compatibility assurance statement – go to The Labelling Handbook and the guidance on tank-mixes for further information
• ensure that all the data requirements have been fully addressed by the submission of reasoned cases, data or accessing data owned by a third party that are no longer protected. Explain how the submitted reasoned cases and/or data address the data requirements. If any submitted data are not in line with good laboratory practice or official recognition, explain why these data can still be used to support your application

How to submit your pesticide application.

Unsuccessful outcome of data submitted to meet data requirements

If you submit data, and upon evaluation it does not address the data requirement for example a specific container, then you will lose the authorisation for the container type and it will be withdrawn from the authorisation at the end of the evaluation.

Data not submitted to meet data requirements

If you do not submit an application, with data, to address a data requirement for continued authorisation of the product, then the authorisation for the whole product will expire at the expiry date. You can submit an application to remove an unsupported container (and the associated data requirements) from your product authorisation.

Extending the expiry date

If you wish to extend the expiry date of a product that is subject to data requirements, you should submit an application at least 3 months before the expiry date.

HSE cannot guarantee that we can successfully evaluate an application for an extension to an expiry date if it is submitted less than 3 months before the specified date.

Apply to extend the pesticide product expiry date: outstanding data

New product application based on a related product with outstanding data requirements

If you wish to submit an application for authorisation of a new product, you should consider whether any related products have outstanding data requirements that are relevant to the authorisation of the new product. Related products are considered as identical or similar products upon which the new product will be based.

This may affect the timing of your application for a new product as follows.

New product application made before the expiry date of the related product and before submission of the related product application

The new product will be issued with the same expiry date and data requirements set as for the related product.
An application to meet the data requirements for the new product must then be submitted before the expiry date. The data requirements application will be considered alongside the related product application so that any regulatory action required after the completion of the related product application can be carried across to the new product.

New product application made after submission but before completion of the related product application

If an application to meet the data requirements for the related product has been accepted, and you want an authorisation issued for your new product before this related product application is completed, you will need to submit two applications for your new product. Please give details of the related product application in your new product application overview.

The first application will allow us to issue an authorisation for the new product with the same expiry date and data requirements as set for the related 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.

New product authorisation not issued until completion of the related product application

If you are able to wait for the conclusion of the related product application, you only need to submit one application for your new product. This can be submitted at any time and we will link your new product application to the ongoing application for the related product and will issue a new product authorisation upon successful completion of the application for the related product. Please give details of the related product application in your new product application overview.

Meeting requirements for further data that relate to the active substance

If you submit an application to meet a data requirement that relates to an active substance in your product, you do not need to submit an application for any other products which have the same data requirement. However, you must notify us of the other products which have this data requirement otherwise authorisation for these products may be withdrawn at the data submission deadline.

If the data requirement is the only outstanding requirement for your product, you must submit an application so that if the data requirement is successfully met an appropriate authorisation can be issued.