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The Applicant Guide: Application types

Introduction

This section provides information on the requirements for submitting your application. Examples of risk and efficacy assessments that you must consider are in the attached document. Detailed checklists for common applications are detailed below. If you wish to submit a different type of application to one detailed here, please contact pesticides&detergents@defra.gsi.gov.uk for further advice. General information and links to other guidance on the documentation required can be found in The Applicant Guide.

Click on the following links for specific information on:

This guidance does not cover EU reviews of active substances or new active substances. Separate guidance is available for these EU applications:

Once the active substances are approved under Regulation (EC) 1107/2009, the guidance in this area should be followed for re-registration of the specific products containing those active substances.

An index of application types is provided below, just click on the type of application you require for more details.

Index of application types

Admin applications (no technical assessment)

New Products-(technical assessment)

Changes to an Existing Product-(technical assessment)

Extensions of Use-(technical assessment)

Trials Permits

Admin applications

These are applications where no technical assessment is required. These applications can be processed during:

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

Content of all admin applications

Unless otherwise stated you must provide the following with any application:

New product identical to existing authorised product (a 'back-to-back')

You may apply for authorisation of a product which is identical to an existing commercially authorised product. The new ('child') product must be identical to the existing ('parent') product in terms of technical specification of the active substance(s), formulation recipe, label recommendations and ownership of the supporting data. We do not check labels for this type of application and labels are based on that of the 'parent'.

You can request authorisation for an identical product:

Where the authorisation of the 'child' is dependent on the outcome of the evaluation for the 'parent', we will consider the 'child' application once the parent is authorised.

If you wish to make applications for Extension of Authorisation for Minor Use (EAMU), as already authorised for an for an identical product, see the Guidance Document for Extensions of Use.

Change of product name, authorisation holder, marketing company – single product

Changes to the product tradename will result in the issuing of a new MAPP number. Changes to the marketing company will result in the issuing of a new MAPP number for your product if the registration number of the marketing company has also changed. Wedo not require an application to change the address of the authorisation holder or marketing company, but please notify us of the changes in writing to applications@hse.gov.uk. Changes to EAMUs to reflect changes above can also be considered via the Admin Stream (see Guidance document for Extensions of Use).

Changes which do not affect MAPP no – multiple products

If your application is for a change to 15 or more products which do not require a new MAPP Number (eg for a change in authorisation holder but not marketing company) we will issue an amendment Notice (often called a 'blanket' Notice), covering all of the products, rather than issue individual Notices for each product. Applications for identical changes for less than 15 products, or where the change requires a new MAPP Number (eg change to marketing company or product name) will be accepted as individual applications.

You must submit:

  1. A covering letter fully explaining your request; and,
  2. A list of the following information for each product (preferably using the table on the application form):
    • Current product name and MAFF/MAPP number
    • current Notice of Authorisation number
    • active substance(s)
    • current/proposed authorisation holder
    • data owner(s) for active substance(s) and formulation/efficacy data
    • if letters of access are required detail whether they are enclosed or to be provided separately
    • any other information (eg highlight ongoing applications that may be affected giving COP numbers)
  3. letters of access to third party data.

Changes to authorised product identical to those considered for another authorised product

If you have submitted an application for a product (the 'lead' product) that requires technical consideration (ie not Admin application) the same changes may be requested for an identical or similar product (the 'trailing' product), via an Admin application (.g. for a change in the statutory conditions of use or change in formulation details). You must consider whether any new authorisation for the trailing product should be based on:

Whilst your application(s) for 'trailing products' may be submitted at any time, we prefer that they are submitted with the 'lead' product. If the application for the lead product is still ongoing we will consider the trailing application once the lead application is authorised. This approach is not possible where a technical assessment would be required to extrapolate the evaluation for the lead product to the trailing product (eg where the formulations are significantly different).

Extension to data submission deadline

If you are unable to meet a data submission deadline you may submit an Admin application to extend the deadline. You must submit your application as soon as you are aware you cannot meet the deadline and at least three months beforehand. You must provide a full explanation as to why you need to extend the deadline, propose a suitable new deadline and submit evidence (eg signed protocols) that the appropriate trials work is underway. Each request will be considered on its merits. Data submission deadlines set as a result of a review of an active substance cannot be extended in this way.

Renewal of Trials Permits

Trials Permits are usually issued for three years. You may submit an Admin application to renew your existing Trials Permit for an additional three years as long as you do not wish to change any of the conditions or restrictions specified on the existing Permit. This does not apply to Administrative Trials Permits (ATPs) for which a new ATP application would be required (see the Guidance Document for Trials Permits).

Change of pack size (within existing range)

You may submit an Admin application for changes in packaging size within a range eg if your approval specifies '1, 2 and 5 litre containers', you can apply to change the approval to '1 to 5 litre containers'. Changes to packaging design, material or sizes outside the authorised range require technical consideration and cannot be considered via the Admin application.

Commercial withdrawal of an authorised use

You may wish to commercially withdraw an authorised use for your product (see The Applicant Guide). As a new authorisation will need to be issued for your product, you will need to submit an Admin Stream application for this change.

In addition, if your product has authorisation for a specific label claim, for which there is an outstanding data requirement that you do not want to address, (this being the only outstanding data requirement for the product), you can submit an Admin application for full authorisation of your product. A new amendment will be added to your authorisation stating that you must remove the claim from the product label.

Applications for identical products can be evaluated during the transition between the national registration under the former The Control of Pesticides Regulations (as amended) 1986 (COPR) and the European registration under the former The Plant Protection Product Regulations 2005 (PPPR), now Regulation (EC) 1107/2009 once the active substance has been included in Annex I of Directive 91/414/EEC (see Legislation Guidance). You must provide:

Updated 2016-11-21