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The Applicant Guide: Application requirements for changes to existing products

These applications will be processed in accordance with the timelines outlined in regulation 1107/2009 as it has effect in Great Britain/Northern Ireland  (see Application Streams and Targets).

Changes to existing plant protection product

New use of an authorised plant protection product

New use(s)/claim(s) on the label must be supported by reasoned cases, data, or extrapolation from data supporting other products' authorisations.

You must:

  1. Fully explain your request in the covering letter
  2. Complete application form CRD 1
  3. Submit any letters of access to third party data that are required
  4. Submit any previous relevant correspondence which must be, at a minimum, a reference to the current authorisation (including COP number, date of issue and Notice of Authorisation Number)
  5. Submit one copy of the proposed product label (this may be included in the dossier structure) and, if necessary, a Compatibility Assurance Statement (see The Labelling Handbook and the guidance document on tank-mixes for further information)
  6. Provide a reasoned case or data to support the new use/claim (consider whether this is a major change), addressing all areas of the risk assessment. If you are claiming comparability to an existing product(s), you must clearly explain how the label claims and recommendations for your product are supported by the different product(s). This information should be provided in the format of an Application Overview
  7. All applications (new product, amendment and renewal) for Plant Protection Products (PPPs) should be made in the form of a draft Registration Report (dRR). Use the dRR templates to create your dRR.
  8. Explain why data that are not in line with Good Laboratory Practice or Official Recognition can still be used to support your application
  9. Consider whether there are any Maximum Residue Level (MRL) implications from the request for authorisation of the new use, for example has the active substance/crop combination had an EC MRL set at the Limit of Determination (see the guidance on MRLs). If so, a full set of residue trials data will be required to allow an increase in the MRL or to show that the MRL will not be exceeded

New use based on Authorisation via article 40 (Northern Ireland only)

Once a PPP has been authorised in EU Member States, following active substance approval and evaluation to Uniform Principles, it is possible to mutually recognise this authorisation in Northern Ireland (see the guidance on authorisation via article 40). This process can also be applied to authorisation for specific uses.

In support of your application you must submit the following:

  1. A copy of the authorisation issued for the reference product in the reference Member State with a translation into English
  2. A finalised core Registration Report for the reference product's evaluation in the reference authority (a complete and summary dossier for the product and each active substance, safener and synergist)
  3. A declaration that the GAP, the active substance technical specification, the formulation recipe, the packaging type and classification labelling are all the same as those for which authorisation has been granted in the reference authority, and that the assessment is to Uniform Principles using EU agreed endpoints
  4. The declaration must state that the finalised core Registration Report is available
  5. A covering letter and detailed application overview, including detailed evidence that the agricultural, plant health and environmental (including climatic) conditions relevant to the use of the product in the reference Member State are comparable with those in Northern Ireland
  6. A signed and completed application form (CRD1)
  7. A copy of the draft UK label for your product
  8. A dRR Part A/B0, detailing the risk management pertinent to the UK, a dRR Part C, and the dRR Part B UK addenda in all relevant areas detailing the risk assessment to address Northern Ireland specific issues
  9. If the product contains a candidate for substitution, a comparative assessment is required.  

For full information see the guidance on authorisation via article 40

Formulation change

A formulation change can be either significant (which may or may not be supported by data), or non-significant in nature. Guidance on significant/non-significant formulation changes is available from the EC website: Guidance document on significant and non-significant changes of the chemical composition of authorised plant protection products under regulation 1107/2009 ) and HSE's notification procedure for dealing with non-significant changes can be found in the applicant guide.

Significant formulation changes that are supported by data usually result in new products (with new MAPP numbers), and you should follow the guidance for new products if the formulation change requires data. Significant changes where no data are required can be made to a product formulation (usually without the need to change the MAPP number).

You must:

  1. Fully explain your request in the covering letter
  2. Complete application form CRD 1
  3. Submit any letters of access to third party data that are required
  4. Submit any previous relevant correspondence which must be, at a minimum, a copy of your product's authorisation. If the authorisation is unavailable, a reference (including COP number, date of issue and Notice of Authorisation Number) must be submitted
  5. Submit reasoned cases or data to address all areas of the risk assessment. This information may be provided in the format of an Application Overview and the areas you should particularly consider are mammalian toxicology, pesticide chemistry and efficacy although residues and ecotoxicology may be affected. You do not usually need to submit labels for a formulation change, although you should provide a justification for the classification for your product (and whether the formulation change will impact upon this). Further information
  6. All applications for PPPs should be made in the form of a dRR. Use the dRR templates to create your dRR.
  7. Submit Safety Data Sheets (SDS) for the co-formulants in your product. A reference should be provided for any SDS that have been previously submitted (including COP number and date submitted)

When making applications for a new formulation you should be aware of the restrictions on the use of unacceptable co-formulants (see guidance on Physical and Chemical Properties ).

Packaging change

You may wish to introduce new packaging types, or materials or sizes other than those originally authorised. Changes to packaging usually only impact in the areas of operator exposure and storage stability, although there may be other concerns.

You must:

  1. Fully explain your request in a covering letter
  2. Complete application form CRD 1
  3. Submit any letters of access that are required
  4. Submit any previous relevant correspondence which must be, at a minimum, a copy of your product's authorisation. If the authorisation is unavailable, a reference (including COP number, date of issue and Notice of Authorisation Number) must be submitted
  5. For refillable bulk containers, small volume returnable containers and any other novel containers, submit one copy of the proposed product label and, if necessary, a Compatibility Assurance Statement (see The Labelling Handbook and the guidance on tank-mixes for further information)
  6. Submit reasoned cases or data to address all the appropriate areas of the risk assessment. This information may be provided in the format of an Application Overview and the areas you should particularly consider are operator exposure, pesticide chemistry and any potential environmental contamination
  7. All applications for PPPs should be made in the form of a dRR. Use the dRR templates to create your dRR.
  8. If you are requesting authorisation for a novel packaging design, submit full details of the packaging specification, including diagrams, and any re-circulating and/or transfer systems. You should also submit details of whether the packaging is returnable or refillable.

Label change

You may wish to make minor changes to your label. In many cases, minor changes will not impact upon the original safety and efficacy assessment, but we need to check that this is the case, and whether those changes need to be supported by data. There are some changes you can make to your label without the need for an application, you should consult the Labelling Handbook for details.

You must:

  1. Fully explain your request in a covering letter
  2. Complete application form CRD 1
  3. Submit any letters of access that are required
  4. 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)
  5. Submit one copy of the proposed product label and a Compatibility Assurance Statement (see The Labelling Handbook and the guidance on tank-mixes for further information)
  6. Submit a justification as to why the proposed label changes do not affect the original safety and efficacy risk assessments for the product.

Meeting a data requirement for continuing authorisation

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, you must:

  1. Fully explain your request in a covering letter
  2. Complete the application form. You must ensure that the form is signed and dated
  3. Submit any letters of access to third party data that are required
  4. 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)
  5. 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 (see The Labelling Handbook and the guidance on tank-mixes for further information)
  6. 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.

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Updated 2021-01-04