The Applicant Guide: Application Requirements for New Products

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

These applications cannot be processed during the transition after renewal of approval of the active substance under Regulation (EC) 1107/2009 before the product authorisation has been renewed unless the submission complies with the renewal end points.

New product similar to existing authorised product

You may apply for authorisation of a product which is similar in formulation to an existing commercially authorised product. Depending on the difference, it may be necessary to provide data (or bridging data), although where the changes are minor, reasoned cases may suffice.

You must:

  1. Fully explain your request in the covering letter of your application
  2. Complete the application form CRD 1
  3. Submit any letters of access to third party data that are required;
  4. Submit any previous relevant correspondence which as a minimum must reference the similar product's authorisation (including COP number, date of issue and Notice of Authorisation Number)
  5. Submit one copy of the draft product label (this may be included in the dossier structure) and, if necessary, a Compatibility Assurance Statement (go to The Labelling Handbook and the guidance on tank-mixes for further information)
  6. Submit a reasoned case addressing all areas of the risk assessment, describing why you consider your product and the authorised product are comparable. It is recommended that this information is provided in the format of an application overview;
  7. All applications (new product, amendment and renewal) for PPP should be made in the form of a draft Registration Report (dRR). Use the dRR templates.
  8. Submit Safety Data Sheets (SDS) for any co-formulants in your product that are not present in the authorised product. A reference should be provided for any SDS that have been previously submitted (including COP number and date submitted);
  9. Submit a full justification for the Classification, Labelling and Packaging of Substances and Mixtures (CLP) for your product. Further information can be found on the HSE website.

When making applications for a new formulation you should be aware of the restrictions on the use of unacceptable co-formulants (go to guidance on physical and chemical properties).

New product supported by a data package

You may apply for authorisation of a product which is a unique formulation. In most cases you will need to provide formulation specific data, but you may be able to support elements of the assessment for the new formulation by extrapolating from other authorised products.

You must:

  1. Fully explain your request in the covering letter of your application
  2. Complete the application form CRD 1
  3. Submit any letters of access to third party data that are required
  4. Submit any previous relevant correspondence which as a minimum must reference the similar product's authorisation (including COP number, date of issue and Notice of Authorisation Number)
  5. Submit one copy of the draft product label (this may be included in the dossier structure) and, if necessary, a Compatibility Assurance Statement (see The Labelling Handbook and the guidance on tank-mixes for further information)
  6. Submit a reasoned case or data addressing all areas of the risk assessment, describing why you consider your product and the authorised product are comparable. It is recommended that this information is provided in the format of an Application Overview
  7. All applications (new product, amendment and renewal) for PPP should be made in the form of a draft Registration Report (dRR). Use the dRR templates.
  8. Submit Safety Data Sheets for any co-formulants in your product that are not present in the authorised product. A reference should be provided for any SDS that have been previously submitted (including COP number and date submitted)
  9. Submit a full justification for the Classification, Labelling and Packaging of Substances and Mixtures (CLP) for your product. There is separate guidance on GB CLP regulation.

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

New product based on unprotected data

You may apply for authorisation of a product which is identical or similar to an authorised product for which data are unprotected. You may choose to access unprotected active substance and/or product data, but either way we will check that the data are unprotected as well as ensure that the active/product/use is sufficiently comparable to the authorised product to allow extrapolation from the unprotected data.

You must:

  1. Fully explain your request in the covering letter of your application, including why you believe the data supporting the source of the active substance and/or product to which you are claiming comparability are no longer protected
  2. Provide reference to a single product (including product names and MAPP numbers) to which you are claiming comparability
  3. You cannot state 'any product containing <named active substance>'. If you do so the evaluation of your application will be stopped and you will be asked to name the individual products and MAPP numbers
  4. Complete the application form CRD 1
  5. Ensure that you show comparability between your product and the one you consider has supporting data that are no longer protected. This information may be provided in the format of an Application Overview
  6. Ensure for new sources of the active substance that the technical specification(s) details include the minimum concentration of the active substance and the maximum concentration of all impurities present at ≥ 0.1% w/w. Submit methods of analysis for the active substance and all the impurities, the method of manufacture, 5 batch analysis data and validation data for all the methods of analysis (see The Data Requirements area for further information)
  7. Submit Safety Data Sheets for all the co-formulants
  8. Submit a full justification for the classification for your product. Further information on classification is available
  9. All applications for PPP should be made in the form of a draft Registration Report (dRR). Further Guidance on the use of a dRR can be found in the folder 'Dossier and draft assessment report' on the European Commission website.
  10. Submit one copy of the draft product label (this may be included in the dossier structure) and a Compatibility Assurance Statement (see The Labelling Handbook and the guidance on tank-mixes for further information).

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).

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 (see the guidance on Authorisation via Article 40 for further information).

In support of your application you must submit the following:

  1. A copy of the authorisation issued for the reference product in the reference authority with a translation into English
  2. 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)
  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 Member State, 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 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;
  6. A signed and completed application form (CRD1);
  7. A copy of the draft UK label for your product;
  8. 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;
  9. 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.

Further information

 
Updated 2021-08-10