This section provides information on the requirements for, and the issues you need to consider, when submitting your application. Summary examples of the areas of the safety risk assessment and efficacy that you will need to consider when submitting certain types of application can be seen in the attached document. More detailed checklists for the most common type of requests are detailed below. If you wish to submit a different type of application to one detailed in this document, please contact our Applicant Enquiries Service for further advice.
More general information on the documentation required when you submit an application can be found in The Applicant Guide, which also provides links to other guidance documents. Further details of the stream your application will be processed under, the time we will take to process your application and the fees charged can be found on our website (streams and fees) and in the Guidance Document on Application Streams and fees.
There are six sections:
- The first section covers simple requests which do not require any technical input, for applications considered via the Admin stream.
- The second section details the requirements for new products, for which authorisation can be sought in a number of different ways.
- The third section details the information you need to provide to make a number of changes to existing products.
- The fourth specifically covers applications for extension of use/off-label applications (formerly known as SOLAs)
- The fifth covers the requirements for experimental permits (EPs)
- The final section details the requirements for re-registration.
This guidance is not intended for use when submitting applications for 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, this guidance should be followed for re-registration of the specific products containing those active substances. An index is provided below, just click on the type of application you require for more details.
Index of application types
Admin applications
New Products
Changes to an Existing Product
Extensions of Use
Experimental permits (EP)
Re-registration
Admin Stream applications
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 approval for an identical product
- When the parent is already authorised (you must provide product name, MAFF/MAPP number, notice of authorisation number); or,
- When the parent is undergoing evaluation but not yet authorised (provide the product name and COP number); or,
- At the same time as requesting approval for the parent (it helps to group the applications for ease of reference).
Where the approval of the ‘child’ is dependant on the outcome of the evaluation for the ‘parent’, we will consider the ‘child’ application once the parent is authorised.
A variation on this is where you wish to make applications for authorisation for the same off-label uses, as approved in an existing Extension of Use authorisation, for an identical product (see the Guidance Document for Extensions of Use).
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:
- A covering letter fully explaining your request and highlighting the parent product; and,
- Completed application form CRD2. You must ensure that the form is signed and dated; and,
- Letters of access to third party data; and,
- Any previous relevant correspondence e.g. a copy of the parent product authorisation. If the authorisation is unavailable, a reference for the parent (including COP number, date of issue and Notice of Authorisation Number) must be submitted.
Change of product name, authorisation holder, marketing company – single product
To change the product trade name, authorisation holder or marketing company of a product you need to submit an Admin Stream application. Changes to the product trade name will result in the issuing of a new MAPP number for your product. 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.
You do not need to submit an application if you wish to change the address of the authorisation holder or marketing company but please notify us of the changes in writing to the Pesticide Branch Applications Sift. Changes to Extensions of Use to reflect the new marketing company can also be considered via the Admin Stream (see the Guidance document for Extensions of Use).
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:
- A covering letter fully explaining your request, detailing the changes to product name/ authorisation holder/marketing company; and,
- Completed application form CRD2. You must ensure that the form is signed and dated; and,
- Letters of access to third party data; and,
- Previous relevant correspondence e.g. a copy of your product authorisation. If the authorisation is unavailable, a reference (including COP number, date of issue and Notice of Authorisation Number) must be submitted.
Change of authorisation holder and other changes – multiple products
If your application is for a change to a number of products which does not require a new MAPP Number to be issued (e.g. for a change in authorisation holder) we will issue an amendment Notice (often called a ‘blanket’ Notice), covering all of the products, rather than issue individual Notices of authorisation for each product.
We will only issue blanket amendment Notices for 15 or more products. Applications for identical changes for less than 15 products, or where the change requires a new MAPP Number to be issued such as change to marketing company or product name will be accepted as individual applications into the Admin Stream.
To help us process the application you must provide basic information for each product.
You must provide:
- A covering letter fully explaining your request; and,
- 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 approval 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 (e.g. highlight ongoing applications that may be affected giving COP numbers)
- 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 (which cannot be considered via the Admin Stream) the same changes may be requested for an identical or similar product (the ‘trailing’ product), via the Admin Stream e.g. for a change in the statutory conditions of use or change in formulation details. You should consider whether any new authorisation for the trailing product should be based on:
- The new authorisation for the lead product e.g. if the lead and trailing products are identical; or,
- The existing authorisation for the trailing product, incorporating any changes made to the authorisation of the lead product. This would apply if the products were similar but the resulting changes were common to both.
Whilst your application(s) for 'trailing products' may be submitted at any time, we would prefer that they were 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. In this case the application for the trailing product would be considered under the No-Data Stream.
You must provide:
- A covering letter fully explaining your request, detailing the changes to be made and the lead product; and,
- Completed application form CRD2. You must ensure that the form is signed and dated; and,
- Letters of access to third party data; and,
- Previous relevant correspondence, such as a copy of your product authorisation/ or the lead product authorisation. If the authorisations are unavailable, a reference (including COP number, date of issue and Notice of Authorisation Number) must be submitted. If the application for the lead product is ongoing, you should provide the COP number for this application.
Extension to data submission deadline
If you are unable to meet a data submission deadline you may submit an Admin Stream application to extend the deadline. You should submit your application as soon as you are aware you cannot meet the deadline and at least three months before the deadline. You must provide a full explanation as to why you need to extend the deadline, propose a suitable new deadline and submit evidence (e.g. 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.
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:
- A covering letter fully explaining your request, detailing the points above; and,
- Completed application form CRD2. You must ensure that the form is signed and dated; and,
- Letters of access to third party data; and,
- Previous relevant correspondence e.g. the product authorisation. If the authorisations are unavailable, a reference (including COP number, date of issue and Notice of Authorisation Number) must be submitted.
Renewal of Experimental Permits
Experimental Permits are usually issued for three years. You may submit an Admin Stream application to renew your Experimental Permit for an additional three years as long as you do not wish to change any of the conditions or restrictions specified on the Experimental Permit. This does not apply to Administrative Experimental Permits (AEP) for which a new AEP application would be required (see the Guidance Document for Experimental Permits).
You must provide:
- A covering letter fully explaining your request and confirming no changes are required; and,
- Completed application form CRD2. You must ensure that the form is signed and dated; and,
- Letters of access to third party data; and,
- Previous relevant correspondence e.g. a copy of the existing experimental permit. If the approval is unavailable, a reference (including COP number, date of issue and Notice of Permit Number) must be submitted.
Change of pack size (within existing range)
You may submit an Admin Stream application for changes in packaging size within a range e.g. 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 Stream.
These types of applications cannot be evaluated during the transition between the national registration formerly known as COPR and the European registration formerly known as PPPR, now Regulation (EC) 1107/2009 once the active substance has been included in Annex I of Directive 91/414/EEC (see our website).
You must provide:
- A covering letter fully explaining your request; and,
- Completed application form CRD2. You must ensure that the form is signed and dated; and,
- Letters of access to third party data; and,
- Previous relevant correspondence e.g. a copy of the product authorisation. If the authorisation is unavailable, a reference (including COP number, date of issue and Notice of Authorisation Number) must be submitted.
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 Stream 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:
- A covering letter fully explaining your request, detailing the use or claim to be commercially withdrawn; and,
- Completed application form CRD2. You must ensure that the form is signed and dated; and,
- Previous relevant correspondence e.g. a copy of the product authorisation. If the authorisation is unavailable, a reference (including COP number, date of issue and Notice of Authorisation Number) must be submitted.Next section
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