The Applicant Guide: data requirements for continuing authorisation

All data requirements must be satisfactorily addressed before an authorisation can be granted. However, we may sometimes issue a time-limited standard authorisation (interim standard authorisation) 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 in time (52 weeks before the expiry date) for the data to be evaluated before the date of expiry specified on the authorisation.

What if the data requirements do not relate to the whole product authorisation?

Where the data requirements relate to a specific container or use, an application to address the data requirements must be submitted to maintain the authorisation for all containers and/or uses. An administrative stream application must be submitted to remove the unsupported containers or uses where the data requirement to support their continuing authorisation will not be met.

What will happen if I do not meet outstanding data requirements?

• If you fail to meet a data requirement for your product, it will lose its authorisation.
• If the data requirement relates to specific uses of your product or claims on your product label, you will lose authorisation for those uses or label recommendations.
• It is the responsibility of the authorisation holder to submit an application to address outstanding data requirements with adequate time for the data to be evaluated in order to maintain the authorisation.

How do I extend a data submission deadline or expiry date?

• If you wish to extend an expiry date you should submit an administrative stream 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.

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 based on a product with data requirements?

If you wish to submit an application for authorisation of a new product, you should also consider whether any related products have outstanding data requirements that are relevant to the authorisation of the new product. Related products can be considered as:

• identical or similar products upon which the new product will be based
• products containing the same source of active substance
• products with different active substances but with other relevant data requirements, eg in relation to specific container types.

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 application is completed, you will need to submit 2 applications for your new product.

The first application will allow us to issue an authorisation 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) 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 authorised, 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 authorisation upon successful completion of the application for the related product.

If an expiry date is imminent for a related product, but an application has not yet been submitted and you submit an application for authorisation of a new product, we will accept and evaluate this application. A second application will be required when the application to meet the data requirement is submitted. 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 of your ongoing application is completed.

1. If the expiry date for the related product has not passed, authorisation will be issued for the new product with the same expiry date. If a second application for the new product is not subsequently submitted, authorisation for this product will expire.
2. If the expiry date has passed and an application has already been submitted for the related product, authorisation 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 4 weeks to submit this application. If you do not submit the second application within this time, authorisation for the new product will be refused.