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The Applicant Guide: Step 2 And Other Issues To Consider For Re-Registration

What do I need to do at Step 2?

At Step 2, you must submit an application under Regulation (EC) 1107/2009 for standard authorisation of your product. This must be supported by a dossier satisfying the product data requirements of Regulation (EC) 1107/2009 and be in accordance with the Uniform Principles and Annex I / approval agreed endpoints.

Products containing existing active substances

Product data packages submitted in support of re-registration applications should ideally be formatted following OECD dossier guidelines or EC dossier guidelines. Dossiers submitted after 1 January 2005 should ideally be in Organisation for Economic Co-operation and Development (OECD) format.

What do I need to submit if my product was the representative product for Annex I inclusion?

If your product was the representative plant protection product for Annex I inclusion/ approval of the active substance and all uses were fully considered at Community level, we will use the Community assessment of these data and the data do not need to be submitted again. However, you will need to provide an up-to-date risk assessment relevant to the UK situation and address efficacy requirements. You will need to submit the following information:

  1. A covering letter clearly explaining how the application is being supported in each area of the risk assessment, indicating that your product was the representative plant protection product for Annex I inclusion;
  2. An application overview,
  3. A signed, dated and fully completed application form ;
  4. Previous relevant correspondence;
  5. A valid letter of authorisation to third party data, where necessary;
  6. One copy of the draft label. Your label will need to satisfy the requirements in paragraphs 1 to 6 of Schedule 3 of PPPR;
  7. A signed and dated compatibility assurance statement (if tank-mixes appear on the label);
  8. Submit a draft Registration Report (dRR) as detailed in the EU Guidance document which is available on the Commission website:
    1. Guidance document on the presentation and evaluation of dossiers according to annex III of Directive 91/414/EEC in the format of a (draft) Registration Report (SANCO/6895/2009).
    2. The dRR presents the same information as the traditional product data dossier and as a result you are no longer required to submit a product data dossier. You are still required to provide the actual studies (doc K where appropriate) which are referenced and summarised in the dRR. If you wish you can provide this in caddy format, placing the dRR where docs M and N would normally be, and Part C of the dRR where doc J would be. There is no equivalent to doc O in the dRR, but this is not a requirement for a product submission in the UK. On completion of the evaluation CRD will routinely release the completed Registration Report (RR) to applicants (with the exception of Part C). In some instances, there may be data provided from parties other than the applicant/authorisation holder. Please note that the RR will not distinguish between different data owners and the complete evaluation will be released to the applicant.
    3. You should use the endpoints in the EFSA conclusion  supporting the Annex I inclusion/ approval . Where you are proposing different or additional endpoints to those in the review report, these will need to be supported by appropriate data and/or information. Please note critical endpoints can only be changed by changing the active substance approval.
    4. You must address any areas highlighted in the review report as requiring particular attention. You should use our environmental checklist to help prepare your environmental assessment;
  9. Biological Assessment Dossier (BAD) addressing efficacy requirements. See Efficacy Guideline 103 in Efficacy Guidelines on preparing a BAD to re-register products containing existing active substances and documents on voluntary worksharing for efficacy evaluations;
  10. Complete product data reference list

If you wish to support uses of a product other than those fully considered for Annex I inclusion/ approval, then you may need to submit further data. If this is the case, you should then follow the requirements for any additional studies (see below).

What do I need to submit for a non-representative product?

For a product that was not a representative formulation for Annex I inclusion/ approval of the active substance, consideration of a full data package will be required. You will need to submit the following information:

  1. A covering letter;
  2. An application overview,
  3. A signed, dated and completed application form ;
  4. Previous relevant correspondence;
  5. A valid letter of authorisation to third party data, where necessary;
  6. One copy of the draft label. Your labels will need to satisfy the requirements in paragraphs 1 to 6 of Schedule 3 of PPPR;
  7. A signed and dated compatibility assurance statement (if tank-mixes appear on the label);
  8. Submit a draft Registration Report (dRR) as detailed in the EU Guidance document which is available on the Commission website:
    1. Guidance document on the presentation and evaluation of dossiers according to annex III of Directive 91/414/EEC in the format of a (draft) Registration Report (SANCO/6895/2009).
    2. The dRR presents the same information as the traditional product data dossier and as a result you are no longer required to submit a product data dossier. You are still required to provide the actual studies (doc K where appropriate) which are referenced and summarised in the dRR. If you wish you can provide this in caddy format, placing the dRR where docs M and N would normally be, and Part C of the dRR where doc J would be. There is no equivalent to doc O in the dRR, but this is not a requirement for a product submission in the UK. On completion of the evaluation CRD will routinely release the completed Registration Report (RR) to applicants (with the exception of Part C). In some instances, there may be data provided from parties other than the applicant/authorisation holder. Please note that the RR will not distinguish between different data owners and the complete evaluation will be released to the applicant.
    3. You should use endpoints in the EFSA conclusion supporting the Annex I inclusion/ approval . Where you are proposing different or additional endpoints to those in the review report, these will need to be supported by appropriate data and/or information. Please note critical endpoints can only be changed by changing the active substance approval.
    4. You must address any areas highlighted in the review report as requiring particular attention.
    5. You should use our environmental checklist to help prepare your environmental assessment; and,
  9. Biological Assessment Dossier (BAD) addressing efficacy requirements. See Efficacy Guideline 103 in Efficacy Guidelines on preparing a BAD to re-register products containing existing active substances and documents on voluntary worksharing for efficacy evaluations;
  10. Complete product data reference list.

What do I need to submit for a similar product?

Where you are planning to extrapolate from data that have already been considered, or are being submitted at the same time for another product (and you have access to the required data), there is no need for you to submit these data again.

You must make the basis for your application clear in your covering letter. We will link your application to the application for the lead product where required.

Your Covering letter / Application Overview must clearly explain how each of the requirements is being met.

You must submit the relevant data and/or information specific to the product as required.

Do I need to submit active substance data?

You will have already demonstrated access to a dossier satisfying the active substance data requirements at Step 1 and you will not need to re-submit the active substance data again. However, where further active substance data are required to support additional uses or scenarios (eg to those considered for Annex I inclusion/ approval), then these will must be provided.

Can I refer to data and/or information previously considered under national legislation (previously COPR)?

Yes, providing this data and/or information is scientifically valid and addresses the product data requirements. It would be useful if you could re-submit these data or alternatively provide a clear reference to when they were previously submitted (eg COP number, date submitted).

What if my product holds a provisional approval under national legislation (previously COPR)?

You will need to submit an application supported by the outstanding data and/or information identified under the national assessment, in time to meet the data submission deadline.

Rather than submitting a full authorisation application under national rules followed later by a separate re-registration application for standard authorisation under EU legislation, you could address the outstanding national (COPR) data requirements as part of your re-registration application. If you do this, you should make this clear in your covering letter. This is so we can take appropriate action to maintain your existing national rules provisional authorisation while we consider your re-registration application.

What will happen to my national rules (COPR ) authorisation?

Six months before the final deadline set for re-registration, we will issue a blanket Notice withdrawing national rules (COPR) authorisations for affected products. The withdrawal will take effect from the final deadline.

From this date the authorisation holder will not be able to place any further national rules (COPR) authorised stocks into the supply chain. However, others will have 6 months to continue marketing and all stocks must be used within 18 months.

When is the earliest I can submit a re-registration application?

We will accept re-registration applications any time after the entry into force date for the relevant Annex I inclusion/ approval .

Can I submit a re-registration application after CRD's Step 2 deadline?

Yes, but we will not issue a new authorisation under EU legislation until a satisfactory assessment has been carried out. This may not be until after the final deadline set by the Commission. In the meantime you (or your agents) will not be able to place any stocks into the supply chain.

Are there any differences between authorisations issued under national rules (previously COPR and Regulation (EC) 1107/2009?

The main difference is that under national rules (COPR), we will allow provisional approvals, with data submission deadlines set for further confirmatory data to address requirements for full approval. Under Regulation (EC) 1107/2009, with the exception of some minor and non-safety related data gaps, we will not be able to issue a standard authorisation unless all product requirements have been addressed.

What if I do not submit a re-registration application or my application is not successful?

We will not be able to issue a standard authorisation for your product under Regulation (EC) 1107/2009. However, providing there are no safety concerns, your national rules COPR authorisation will be allowed to continue as detailed above.

To gain a standard authorisation under Regulation (EC) 1107/2009, you must submit a new application supported by the required information.

Products containing new active substances

In granting a national provisional authorisation for a product under Regulation (EC) 1107/2009, we will already have considered a dossier satisfying the product data requirements for the requested uses. At re-registration, we need to take on board the assessment carried out at Community level and confirm that the use of the product under UK conditions satisfies the Uniform Principles and Annex I / approval agreed end points.

Do I need to submit a new product data dossier?

There will be no need for you to provide a new summary dossier or to re-submit data that we have already considered, when granting a national provisional authorisation for the product under Regulation (EC) 1107/2009, or at Community level (eg where your product was the representative formulation considered for the purpose of Annex I Inclusion/ approval).

You therefore have a choice as to how you address each product data requirement:

When will I need to provide new data and/or information?

You may need to submit new data and/or information in the following situations:

Some of the open points may already have been fulfilled at Community level, with an evaluation by the Rapporteur Member State (RMS) for the active substance. These data will usually be listed in Appendix III of the review report supporting the Annex I inclusion, with conclusions reached in the Evaluation Table. We will accept the evaluation carried out at Community level and will not re-evaluate such data again.

What do I need to submit in support of my application?

You will need to submit the following:

  1. A covering letter;
  2. An application overview,
  3. A signed, dated and completed application form ;
  4. Previous relevant correspondence;
  5. A valid letter of authorisation to third party data, where necessary;
  6. One copy of the draft label. Your labels will need to satisfy the requirements in paragraphs 1 to 6 of Schedule 3 of PPPR;
  7. A signed and dated compatibility assurance statement (if tank-mixes appear on the label);
  8. Submit a draft Registration Report (dRR) as detailed in the EU Guidance document which is available on the Commission website:
    1. Guidance document on the presentation and evaluation of dossiers according to annex III of Directive 91/414/EEC in the format of a (draft) Registration Report (SANCO/6895/2009).
    2. The dRR presents the same information as the traditional product data dossier and as a result you are no longer required to submit a product data dossier. You are still required to provide the actual studies (doc K where appropriate) which are referenced and summarised in the dRR. If you wish you can provide this in caddy format, placing the dRR where docs M and N would normally be, and Part C of the dRR where doc J would be. There is no equivalent to doc O in the dRR, but this is not a requirement for a product submission in the UK. On completion of the evaluation CRD will routinely release the completed Registration Report (RR) to applicants (with the exception of Part C). In some instances, there may be data provided from parties other than the applicant/authorisation holder. Please note that the RR will not distinguish between different data owners and the complete evaluation will be released to the applicant.
    3. You should use endpoints in Appendix I of the review report supporting the Annex I inclusion/approval. Where you are proposing different or additional endpoints to those in the review report, these will need to be supported by appropriate data and/or information.
    4. You must address any areas highlighted in the review report as requiring particular attention.
    5. You should use our environmental checklist to help prepare your environmental assessment; and,
  9. Individual test and study reports in accordance with the requirements specified in the product data requirements.
  10. You should only submit those studies that have not previously been evaluated by CRD or by the RMS for the purpose of Annex I Inclusion/approval of the active substance. You should submit any updated assessments relied upon in the Application Overview (for example using Annex I/approval agreed endpoints); and,A Biological Assessment Dossier (BAD) addressing efficacy requirements. See Efficacy Guideline 103 in Efficacy guidelines on preparing a BAD to re-register products containing existing active substances and documents on voluntary worksharing for efficacy evaluations; and, Complete product data reference list. The list should indicate:
    1. Which of the studies are new and require evaluation (see (h) and (i) above); and,
    2. Which of the studies have already been evaluated at Community level; and,
    3. If not, which studies have previously been considered by CRD (in which case the Application Reference and original date of submission should be provided).

What will happen to my Regulation (EC) 1107/2009 national provisional authorisation?

After a new active substance has been included in Annex I/ approved, we will issue a blanket Notice amending the expiry dates for any national provisional authorisations of products containing that active substance, in line with the dates set for re-registration. The national provisional authorisation issued for your product under Regulation (EC) 1107/2009 will be allowed to continue to the final deadline.

After this date, you (or your agents) will not be able to place any further stocks into the supply chain. However, others will have one year to continue marketing and using stocks already in the supply chain.

When is the earliest I can submit a re-registration application?

We will accept re-registration applications any time after the entry into force date for the relevant Annex I inclusion/ approval.

Can I submit a re-registration application after CRD's Step 2 deadline?

Yes, but we will not issue a Regulation (EC) 1107/2009 standard authorisation until a satisfactory assessment has been carried out. This may not be until after the final deadline set by the Commission. In the meantime you (or your agents) will not be able to place any stocks into the supply chain.

What if I do not submit a re-registration application or my application is unsuccessful?

We will not be able to issue a standard authorisation for your product under Regulation (EC) 1107/2009. However, providing there are no safety concerns, your national provisional authorisation will be allowed to continue as detailed above.

To gain a standard authorisation under Regulation (EC) 1107/2009 you will need to submit a new application supported by the required information.

What else do I need to consider at re-registration?

What about classification and labelling of my product?

The labelling handbook details the general labelling requirements for all products. In addition to this all products must be classified and labelled in accordance with the CLP Regulation (EC Regulation On Classification, Labelling and Packaging of Substances and Mixtures, EC 1272/2008). Further details are given in 'Introduction to Classification and Labelling for PPP's'

What about Maximum Residue Levels?

We cannot issue an authorisation under Regulation (EC) 1107/2009 unless EC Maximum Residues Levels (MRLs) have been established in Regulation 396/2005 for the active substance/crop combination referred to in the authorisation and that these accommodate the use.

Once an active substance has been Annex I included/approved, the EC temporary MRLs set in Annex III of Regulation 396/2005 will be reconsidered for all uses, not just those considered for the purpose of Annex I Inclusion/approval, and deleted where there are no data to support the MRL. However, where there is confirmation that the necessary data have been generated then the EC temporary MRL will be retained for a further period of time to allow for re-registration.

What if I want to apply for Mutual Recognition in another Member State?

As soon as a standard authorisation under Regulation (EC) 1107/2009 has been issued for your product (ie an authorisation has been issued under the terms of Regulation (EC) 1107/2009), you will be able to apply for mutual recognition of this authorisation in other MS. You should contact individual MS for details of their requirements for such an authorisation.

Further information

Updated 2017-01-06->->->