Pesticide active substance source changes: technical equivalence

Overview

The technical equivalence of an active substance needs to be assessed in the context of a Plant Protection Product (PPP) authorisation when there has been a change to the source of the active substance. This is to ensure the new source of active substance is just as safe as the approved source detailed in the Draft Assessment Report (DAR)/Renewal Assessment Report (RAR).

In order to include a new source in a product to be marketed in the UK you will need to submit separate technical equivalence applications for Great Britain and Northern Ireland.

You can also submit an application for consideration in Great Britain only of a new source without inclusion in an existing product, for example when you do not hold an authorisation for a PPP in the UK. These applications are also known as a ‘standalone’ technical equivalence applications and are considered as the first stage of a two stage application for PPP authorisation.

When to apply for technical equivalence

You need to apply for a technical equivalence assessment if:

• you want to produce your active substance in a new location
• you wish to change the method of manufacture for your active substance
• the technical specification of your active substance has changed, such as when any new, relevant, or significant impurities have been noted
• you change your scale of manufacture from pilot to full scale

When these changes occur, it is referred to as a new source of the active substance. You can request that a new source is considered as part of another application, for example an amendment to an existing PPP. Additional fees will apply for the work specifically relating to the technical equivalence assessment. You should note that when you request the consideration of technical equivalence for more than one source at the same time or within the same application then a full set of fees for the consideration of equivalence will be charged for each source.

Source is already included in a UK product authorisation

If the source of active substance you want to include has already been considered equivalent to the approved source and an authorisation issued for a UK PPP that includes this source, no technical assessment is required, you can submit an admin application.

You will need to submit:

• application form CRD2 giving details of the UK product authorisation which includes the new source
• a covering letter outlining your request, including details of the UK product in which the source is already included
• letter of supply if the source is from a third party
• letters of access if:
• you are not the authorisation holder of the relevant plant protection product
• you are not the owner of the 5-batch data
• access is required to protected active substance data

You need to submit separate applications for each product authorisation you want this source to be added to.

Cost and timescales

You will be charged the appropriate admin fee for each application.

Your application will be considered in the admin stream to the timescales set out.

Applications for Great Britain

In order to apply for technical equivalence in Great Britain, you will need to submit:

• an application form:
• CRD8 if you do not have a PPP authorisation and do not intend to submit an application for one at this time
• CRD1 if you hold a PPP authorisation or are applying for a new PPP authorisation
• a covering letter outlining your request
• an application overview detailing how you propose to address the data requirements
• a draft technical equivalence report containing a summary of the data and information submitted - EC assessment guidance
• Data or reasoned scientific cases to address all the appropriate data requirements (Part A of section 1 and 4.1.1. of Regulation 283/2013 (Physical and Chemical Properties)
• Other data as appropriate, guidance for which is located under Toxicology – Active Substances and the guidance document on the assessment of the equivalence of technical materials
• letter of supply if the source is from a third party
• letters of access if:
• you are not the owner of the 5-batch data
• access is required to protected active substance data
• if you do not have access to the technical specification then a separate document from the manufacture of the source material detailing the technical specification along with a declaration that it is true and correct

Detailed checks

As part of the standard checks we complete at the validation check for technical equivalence applications, your submission will also be sent for a detailed check by a chemistry specialist assessor. These detailed checks are to make sure specific information that is relevant to the tier 1 chemistry assessment are available for evaluation. This specific information includes, but is not limited to:

• a completed draft technical equivalence report
• whether batch analysis studies are to GLP standard
• full name and address details of the manufacturing site
• a detailed technical specification (if submitted as a separate document, then the technical specification should agree with the specification given in the CRD8 or CRD1 form)
• a method of manufacture that includes a chemical reaction scheme and brief details (including reaction conditions, temperatures and suchlike) for each step
• a list of the starting reagents and process solvents used in the method of manufacture detailing purity, maximum levels of impurities present if applicable (for example, dioxins, furans, and nitrosamines), and a statement on the commercial availability
• details on the batches analysed, including dates of manufacture, batch weights, and whether production is to pilot or commercial scale
• if the batches are over 5 years old, a statement confirming that they are still representative of the manufacturing process

You can find further information on common omissions using this checklist. Check your dossier against this list to ensure it is complete before submitting your application.

Cost and timescales

You will be charged the standard fees (usually sift, co-ordination, chemistry data and toxicology case fee modules; but toxicology and ecotoxicology case/data modules could be charged depending on what is submitted, and the risk assessment required).

If you apply for a standalone technical equivalence application, you will be charged the full set of fees, as above, for the initial assessment, and when you submit the second stage of your application for PPP authorisation the relevant fee modules, dependent on the data, cases or information submitted, will be charged. If you do not submit a second stage and the application is closed, but you subsequently apply to have that source included in an existing product used in GB, you will be charged the fees for an admin application.

We will aim to notify you of our decision on the assessment within the timeline for authorisation under Article 33 and 34.

Applications for Northern Ireland

As part of withdrawal agreement for leaving the EU, Great Britain cannot act as lead evaluator for any assessment involving Northern Ireland.

This means, for Northern Ireland applications:

• we can only recognise a new source of active substance that has already been considered to be equivalent to the EU approved source by a European Union (EU) Member State (MS)
• we cannot conduct an assessment of any data
• the new source can only be considered for an authorised UK product or proposed PPP

In order to apply for technical equivalence in Northern Ireland, you will need to submit:

• an application form CRD1
• a covering letter outlining your request
• a statement of equivalence or a notice of authorisation from the EU member state that assessed the technical equivalence, or a copy of the redacted technical equivalence report you received from that EU member state

We will verify the information submitted to us with the EU Member State that completed the assessment in order to support your application. We will request a copy of their final unredacted technical equivalence report and your application will not be accepted until we have received it.

Cost and timescales

You will be charged the sift, admin authorisation and chemistry case fee modules.

We will aim to notify you of our decision within the timeline for Article 33 amendment applications.

If your application has been rejected

If your application was rejected at the applications sift, this means it was lacking in in one or more areas of the assessment, or you did not supply the necessary information and/or documentation we require to complete the application, such as those mentioned above under ‘Detailed checks’. If this occurs, we will communicate to you the information that was missing, and you will be charged a sift fee for the cost of checks undertaken on your submission.

Once your application has been accepted

We will tell you when we have completed our assessment with our decision on technical equivalence and if any amendments to the technical specification have been proposed.

If we need more information, to enable us to complete our assessment, we will send you a request. You will need to submit any further information or data by the deadline specified. The legal deadline of the application will be extended by the time taken for you to submit the requested information. If your response includes a case or new data, we will charge further fees. If we have not received your response by the deadline or if your reply does not satisfactorily address our request, we will complete your application as far as possible. This may result in either complete or partial refusal of your application.

In the case of a standalone technical equivalence application, if you wish to include this source of technical material in a plant protection product you will need to confirm this within 2 weeks from the date of completion of the assessment. You will then have 13 weeks to submit all the information and data necessary to support a product authorisation, referring to the relevant application reference (COP number) in your covering letter. Otherwise, the application will be closed.

If you have already told us of the PPP you wish to use your new source in, the appropriate data access has been demonstrated, it has been agreed that the source is technically equivalent, and you have received the new Notice of Authorisation, you can market your PPP with this source in it.

New sources of an active substance that has been renewed

Specific guidance is available on technical specifications and formulation and technical specifications at renewal.

Relevance of EU assessments for technical equivalence

If a source has been considered equivalent to the approved source in the EU but not included in an existing UK product, this decision can only be used to support inclusion of the source in a product authorisation for Northern Ireland, as explained above. If you wish to include it in a GB authorisation, then you will need to apply for full GB technical equivalence assessment.

Full assessments conducted by the UK prior to leaving the EU can still be used to support inclusion in an authorisation for an existing UK product. This can be applied for as an admin application.

If a source was originally assessed in the EU and authorised for inclusion in a UK product prior to the UK leaving the EU, the source can still be included in another existing UK product. This can be applied for as an admin application.