The Applicant Guide: Application types
This section provides information on the requirements for submitting your application. Examples of risk and efficacy assessments that you must consider are in the summary 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 [email protected] 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:
- Types of Application Streams, and Guidance on Application Streams
- Fees Charged for Individual Application Types) and Guidance on Fees.
This guidance does not cover applications for the renewal of active substances in Great Britain or applications for new active substances in Great Britain. Separate guidance will be available for these applications.
Separate guidance on how to make applications for new active substances in the European Union, and for the renewal of existing active substances across the European Union, is available on the European Food Standards Agency (EFSA) website:
Once the active substances are approved, the guidance in this area should be followed for renewal 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 product identical to existing authorised product (a 'back-to-back').
- Change of product name, authorisation holder, marketing company – single product
- Change of authorisation holder and other changes – multiple products
- Changes to authorised product identical to those considered for another approved product
- Extension to data submission deadline
- Renewal of a trials permit
- Change of pack size (within existing range)
- Commercial withdrawal of an authorised use
New products-(technical assessment)
- New product similar to existing authorised product
- New product supported by full data package
- New product based on unprotected data
- New product using Article 40
- New Northern Ireland only parallel permit product
- New Northern Ireland only own-use parallel permit
Changes to an Existing product (technical assessment)
- New use of an authorised product
- New use using Article 40
- Formulation change
- Packaging change
- Label change
- Additional convenience tank-mixes
- Meeting a data requirement for continuing authorisation
Extensions of authorisation for minor use (EAMU) (technical assessment)
- Extension of authorisation for minor use (formerly known as SOLA)
- Extension Authorisation for Minor Use based on recognition of another competent authority assessment (Articles 40, 42 and 51 of Regulation 1107/2009(GB/NI)
- Administrative trials permits
- Extrapolated trials permit
- Consumer-assessed trials permit
- Fully-assessed trials permit
These are applications where no technical assessment is required. These applications can be processed during the transition after renewal of approval of the active substance under Regulation 1107/2009 (GB/NI) but before the product authorisation has been renewed.
Content of all admin applications
Unless otherwise stated you must provide the following with any application:
- a covering letter fully explaining your request and detailing the requirements below
- completed application form CRD2
- letters of access to third party data
- any previous relevant correspondence for example a copy of the parent product authorisation, previous authorisation/trials permit/EAMU as appropriate or any written advice previously provided by HSE
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:
- when the parent is already authorised (provide product name, MAPP number, notice of authorisation number)
- when the parent is undergoing evaluation but not yet authorised (provide product name and COP number)
- at the same time as requesting authorisation for the parent (grouping applications for ease of processing)
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 for extensions of authorisation for minor 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. We do 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 [email protected]. Changes to EAMUs to reflect changes above can also be considered via the Admin Stream (see Guidance for extensions of authorisation for minor 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 (for example 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 (for example change to marketing company or product name) will be accepted as individual applications.
You must submit:
- A covering letter fully explaining your request
- 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 (for example highlight ongoing applications that may be affected giving COP numbers)
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 (not an admin application) the same changes may be requested for an identical or similar product (the 'trailing' product), via an admin application (for example 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:
- the new authorisation for the lead product, for example if the lead and trailing products are identical
- 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 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 (for example where the formulations are significantly different).
Extension to the expiry date for products with outstanding data requirements for continuing authorisation
If you are unable to meet a requirement and submit an application 12 months before the expiry date you may submit an Admin application to extend the expiry date. 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 expiry date, propose a suitable new deadline and submit evidence (for example signed protocols) that the appropriate trials work is underway. Each request will be considered on its merits.
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 if you do not wish to change any of the conditions or restrictions specified on the existing permit. If the trial permit has a data requirement for renewal of the permit then it cannot be extended via the admin stream; a technical application is required. This does not apply to administrative trials permits (ATPs) for which a new ATP application would be required (see the Guidance for trials permits).
Change of pack size (within existing range)
You may submit an admin application for changes in packaging size within a range. For example if your authorisation specifies '1, 2 and 5 litre containers', you can apply to change the authorisation 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.