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The Applicant Guide: Application Requirements for New Products

These applications will be processed in accordance with the timelines outlined in Regulation No 1107/2009 (See Application Streams and Targets).

These applications cannot be processed during:

See Under what legislation will my application be processed? for full details.

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; and,
  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 must be, at a minimum reference to 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 document 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). Further Guidance on the use of dRR can be found in the folder 'Dossier and draft assessment report' on European Commission website
  8. Submit Material 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 MSDS that have been previously submitted (including COP number and date submitted);
  9. Submit a full justification for the Chemical Hazards Information and Packaging (CHIP) classification for your product. Further information can be found on HSE website.

When making applications for a new formulation you should be aware of Directive 2003/53/EC which concerns the replacement of nonylphenol, octylphenol and their ethoxylates (NPEs and OPE) in pesticide formulations. Plant protection products in the UK must comply with this directive in that the concentration of any NPEs or OPEs must be less than 0.1 % w/w.

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; and,
  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 must be, at a minimum reference to 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 document 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). Further Guidance on the use of dRR can be found in the folder 'Dossier and draft assessment report ' on European Commission website
  8. Submit Material 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 MSDS that have been previously submitted (including COP number and date submitted);
  9. Submit a full justification for the Chemical Hazards Information and Packaging (CHIP) classification for your product. Further information can be found on HSE website.

When making applications for a new formulation you must be aware of Directive 2003/53/EC which concerns the replacement of nonylphenol, octylphenol and their ethoxylates (NPEs and OPEs) in pesticide formulations. Plant protection products in the UK must comply with this directive in that the concentration of any NPEs or OPEs must be less than 0.1 % w/w.

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 MAFF/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 MAFF/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 Material Safety Data Sheets for all the co-formulants;
  8. Submit a full justification for the classification for your product. Further information on classification;
  9. All applications for PPP should be made in the form of a draft Registration Report (dRR). Further Guidance on the use of dRR can be found in the folder 'Dossier and draft assessment report' on 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 document on tank-mixes for further information).

When making applications for a new formulation you should be aware of Directive 2003/53/EC which concerns the replacement of nonylphenol, octylphenol and their ethoxylates (NPE and OPE) in pesticide formulations. Plant protection products in the UK must comply with this directive in that the concentration of any NPE or OPE must be less than 0.1 % w/w.

New product based on Mutual Recognition

Once a product has been authorised in other 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 the UK (see the guidance on Mutual Recognition 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 Member State 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 on CIRCABC.
  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 the UK;
  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 UK specific issues;
  9. If the product contains a candidate for substitution, a comparative assessment is required.

For full information see document on Mutual Recognition

New parallel import product

You may wish to import a product into the UK (for marketing) which is identical to a UK authorised product. Please refer to the guidance on Parallel Trade Permits.

These types of applications cannot be accepted and evaluated during the transition between national legislation (previously referred to as COPR and EU legislation under Regulation (EC) 1107/2009 once the active substance has been approved (see our website).

New own-use parallel import product

You may wish to import a product into the UK for your own use, which is identical to a UK authorised product. Please refer to the guidance on parallel trade permits and own-use parallel trade permits. These types of applications cannot be accepted and evaluated during the transition between national legislation (previously referred to as COPR and EU legislation under Regulation (EC) 1107/2009 once the active substance has been approved (see our website).

Further Information

Updated 2016-11-16