The Applicant Guide: Common Ommissions Checklist For Applications

Are you seeking a ‘full’ zonal assessment or UK only assessment?

Under a ‘full’ zonal assessment, CRD will conduct an assessment of all relevant areas of the core assessment including those that are not relevant for a UK authorisation (e.g. German operator exposure model and groundwater assessments for scenarios not relevant to the UK). An additional partial dossier fee will apply as detailed in The Applicant Guide: Zonal authorisations and mutual recognition under Regulation (EC) 1107/2009 Have you made it clear that you understand that this fee will be applied and indicated your agreement to this?

If a full zonal assessment are you requesting that CRD assess uses that are not sought in the UK?

Providing UK authorisation of the product is sought, CRD can assess non UK uses. Please note that an additional fee applies as detailed in the The Applicant Guide: Zonal authorisations and mutual recognition under Regulation (EC) 1107/2009 Have you made it clear that you understand that this fee will be applied and indicated your agreement to this?

Has the zRMS been agreed before submission of the application?

If you are requesting that the UK are zRMS, we will only accept your application when it has already been agreed zonally that other MSs are content for the UK to undertake this work. Such agreement should be sought in the pre-submission period as detailed in The Applicant Guide: Zonal authorisations and mutual recognition under Regulation (EC) 1107/2009 Have you made it clear that you understand that this fee will be applied and indicated your agreement to this?

Does the submission address all of the UK specific elements?

This applies to all zonal submissions but particularly when the zRMS is not the UK (i.e. following zonal submissions). For details of UK specific requirements please refer to Specialist guidance for mutual recognition.

These should be addressed within national addenda to the dRR and a UK specific Part A.

Is the application for re-registration? If so does it include a formulation change or new uses?

If it does, detail the changes and how they are supported.

Was the formulation and/or uses considered in the DAR or has it been subject to a previous uniform principles assessment?

Give details of any previous assessments e.g. COP number, product name.

Is your application for re-registration of a national provisional authorisation?

If so, a full Uniform Principles Assessment will have been conducted previously, using end points agreed at a Member State level. Please compare the end points used in the previous UK assessment with those detailed in the EFSA conclusion. Your application should focus on addressing any data gaps and reassessing areas of the risk assessment where underlying end points have changed. A dRR should be submitted but part Bs only need to be provided where new data evaluation or risk assessment is required. Please also address any open points in the EFSA conclusion. Your must submit a draft label.

Are there any confirmatory data requirements?

Please detail whether the inclusion is subject to confirmatory data requirements. Have the requested data been submitted to the RMS and if so when is the assessment expected?

Are details of the proposed GAP the same in all sections of the dRR and on the draft label?

Please check this before submitting the application.

Are all MSDSs in accordance with Regulatory Update 07/2011

If it is not possible to obtain an MSDS less than 2 years old and in EU format, please detail this in the application overview and provide evidence from the supplier that this is the most recent MSDS.

Have you explained how each area of the assessment is being approached e.g. by data/ case or reference to a previous assessment and highlighted any salient points?

Detail this in the application overview

Are the formulation details complete and expressed in the correct units?

E.g. are all the tradenames, chemical names CAS numbers present in the application forms. Concentrations for liquid formulations should be presented in g/l or w/v (not w/w). Please ensure that the formulation details are the same as in Part C of the dRR.

Have full details of the proposed packaging been included?

For layered packaging materials, please make it clear which layer is in contact with the product. Please check the packaging on the application form and within the dRR are the same.

Are all sections of the dRR in word format.

You may submit PDF versions, but if you do we additionally require word versions.

Have you included original copies of all necessary letters of access?

Please ensure that data access is clearly explained. If you are relying on letters of access that were submitted previously or are due to follow, please explain this. For previously submitted letters of access detail the date and application they were previously submitted for.