Supplementary information (MRL confirmatory data)
You might be asked to submit supplementary information (MRL confirmatory data) following:
- MRL reviews
- establishment of temporary MRLs
Any supplementary information required will be laid out in the reasoned opinion, decision document and as a footnote in the GB MRL register.
There may be outstanding requirements for supplementary information as a result of EU retained laws relating to MRLs.In this case the EFSA Reasoned Opinion will outline the full list of the supplementary information required and the data should be provided to HSE.
Supplementary information must be submitted to HSE by the submission deadline. If it is not submitted, the MRL will not be fully supported. This could result in the MRL concerned being reduced to either a fall-back GAP or the limit of determination. HSE will withdraw authorisations that are not supported by an appropriate MRL.
Data to address the outstanding data gaps can be submitted as part of an application for:
- PPP authorisation if the data are essential to support a GAP
- a new MRL
- a specific application to consider the supplementary information
Highlight in the covering letter and application overview that the submission includes supplementary information and submit supplementary information in an evaluation report (ER) using the relevant template and a CRDMRL application form.
HSE recommends that stakeholders collaborate to address the requirements to ensure the MRLs are maintained..
Find further guidance on applying for new MRLs.
These fee categories give you an idea of fee levels, find full details of the current fees charged.
As part of a PPP authorisation
The supplementary information can be evaluated as part of a product authorisation if the information is critical to support the new GAP.
No additional fees, on top of those charged for the product authorisation assessment, are charged for the assessment of the supplementary information.
As part of an application for a new MRL
Find out the fee categories for MRL applications.
A specific application to consider the supplementary information only
For standalone applications to address MRL supplementary information, you will be charged
- a sift fee
- a coordination fee
- an additional fee for each category of supplementary information
Simple reasoned case
Metabolism and residues evaluation
HSE calculates the fees for multiple submissions for the same active substance on a modular basis. You will be charged a fee for each point of supplementary information.
Large or novel studies which require significant extra work will incur an additional fee. This will be a multiple of the original fee.
Multiple applications to address the same supplementary information will be each charged the full fee. HSE will consider all the supplementary information together as part of an overall assessment.