The Applicant Guide: Application Requirements for New Products

These applications will be processed in accordance with the timelines outlined in (EC) Regulation No 1107/2009 as it has effect in Great Britain/Northern Ireland for further information see Application Streams and Targets).

New product not requiring technical assessment

For new products which do not require technical assessment, please refer to Admin applications.

New product supported by a data package

You may apply for authorisation of a product which is a unique formulation, or which is similar in formulation to an existing commercially authorised product. In most cases, you will need to provide formulation specific data. You may also be able to support elements of the risk assessment for the new formulation by extrapolating from, or providing ‘bridging’ data to, other authorised products. Where the changes are minor, reasoned cases may suffice.

Note: these applications can only be processed after renewal of approval of the active substance in either Great Britain or Northern Ireland under Regulation (EC) No 1107/2009 where the submission complies with the renewal end points.

The application must include the following:

A full explanation of your request in the covering letter.
A completed application form CRD 1.
Any letters of access to third party data that are required.
Any previous relevant correspondence of a previous/similar assessment (include product name, COP number).
One copy of the draft product label and, if necessary, a Compatibility Assurance Statement (for further information go to The Labelling Handbook and the guidance on tank-mixes).
A reasoned case or data addressing all areas of the risk assessment. It is recommended that this information is provided in the format of an Application Overview.
A draft Registration Report (dRR).
Safety Data Sheets for all 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 must be aware of the restrictions on the use of unacceptable co-formulants (For further information go to Physical and Chemical Properties).
Submit a full justification for the Classification, Labelling and Packaging of Substances and Mixtures (CLP) for your product. For further information go to CLP regulation.

New product citing data for which data protection has expired

You may apply for authorisation of a product which you believe is comparable to an authorised product. Article 34 of Regulation (EC) No 1107/2009 exempts you from the need to supply supporting data where the competent authority has already assessed relevant, supporting studies to support authorisation and where the data protection period for all relevant supporting active substance and reference product studies has expired at the time of application (for further information see Data Protection).

Note: these applications cannot be processed during the period after renewal of approval of the active substance in either Great Britain or Northern Ireland under Regulation (EC) No 1107/2009 and before the reference product authorisation has been renewed (known as ‘the frozen period’). Data are typically protected at product renewal.

Limitations when making an application under Article 34 of Regulation (EC) No 1107/2009 (citing data for which data protection has expired)

Only one reference product can be considered per application.
Only one new source of active substance, to be considered via GB technical equivalence, will be considered per application.
If applicable, data access (for example letters of access) must be in place at the time of application.

The application must include:

A full explanation of your request in the covering letter, including why you believe the data supporting the source of the active substance and/or reference product to which you are claiming comparability are no longer protected.
A completed application form CRD 1.
Any letters of access to third party data that are required.
Any previous relevant correspondence, for example of a previous assessment (including product name, COP number).
One copy of the draft product label and, if required, a Compatibility Assurance Statement (go to The Labelling Handbook and the guidance on tank-mixes for further information).
The product name and MAPP number of a single reference product to which you are claiming comparability. We do not accept general references to "any product containing <named active substance>" you must state one single reference product.
Demonstration of comparability between your product and the reference product. This information may be provided in the form of an Application Overview.
A draft Registration Report (dRR) (at a minimum Part A and C).
Safety Data Sheets for all the co-formulants. When making applications for a new formulation you must be aware of the restrictions on the use of unacceptable co-formulants (for further information go to Physical and Chemical Properties).
Submit a full justification for the Classification, Labelling and Packaging of Substances and Mixtures (CLP) for your product. For further information go to CLP regulation.
If relevant - draft technical equivalence report and supporting data for a new GB source as detailed on the technical equivalence page. This same page also includes information on applying for a new source in Northern Ireland, which must be submitted under a separate application.

Note: you may apply for authorisation of a product which is comparable to an authorised product where the data protection period for all relevant supporting active substance and product studies has not expired. In this case, you must demonstrate access to the supporting studies. This may be via a letter of access from the data owner (go to guidance on Letters of Access).

Acceptance of application

HSE will not check data access or the data protection status at the sift stage of the application.

Evaluation

HSE will check that (where appropriate):

the data cited were unprotected at the time of application. HSE will inform you of the outcome prior to the assessment of the formulation comparison. HSE will refuse authorisation if some or all of the data being relied upon were protected at the time of application, even if the data protection expires prior to the completion of the assessment.
any new source of active substance is technically equivalent to the reference source, in accordance with SANCO Guidance Doc 10597/2003.
the proposed new product’s formulation is sufficiently comparable to that of the reference product, in accordance with SANCO Guidance Doc 12638/2011.
the reference product assessment is still valid.

Refusal outcome

HSE will refuse authorisation if some or all of the data being relied upon were protected at the time of application, even if the data protection expires prior to the completion of the assessment. HSE will complete the assessment including the registration report, concluding on the formulation comparability. If no authorisation is recommended we will not undertake a check of the draft label. You may cite the conclusions of a previous application in any new application submitted once the data protection period for the reference product expires. In this situation, there must have been no intervening changes in assessment standards and the conclusions should remain valid.

New product based on Authorisation via Article 40 (Northern Ireland only)

Once a plant protection product has been authorised in EU member states, following approval of the active substance under Regulation (EC) 1107/2009 and subsequent products evaluation to Uniform Principles, it is possible to mutually recognise this authorisation in Northern Ireland (go to the guidance on Authorisation via Article 40 for further information).

In support of your application you must submit the following:

A copy of the authorisation issued for the reference product in the reference authority with a translation into English.
A finalised core Registration Report for the reference product's evaluation in the reference member state (a complete and summary dossier for the product and each active substance, safener and synergist).
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 member state, and that the assessment is to Uniform Principles using EU agreed endpoints.
The declaration must state that the finalised core Registration Report is available.
A cover 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.
A signed and completed application form (CRD1).
A copy of the draft UK label for your product.
A draft Registration Report Part A/B0, detailing the risk management pertinent to the UK, a draft Registration Report part C, and the draft Registration Report Part B UK addenda in all relevant areas detailing the risk assessment to address Northern Ireland specific issues.
If the product contains a candidate for substitution, a comparative assessment is required.

For application requirements go to the guidance on Authorisation via Article 40.

New Northern Ireland only parallel trade permit and Northern Ireland only own-use parallel trade permit

You may wish to import a product into Northern Ireland for marketing or for your own use, which is identical to a Northern Ireland authorised product. Please refer to the guidance on Northern Ireland only parallel trade permits and Northern Ireland only own-use parallel trade permits.