Changes to Approved Products (Advice Sheet 4)
Version 5.8 , June 23
Introduction
All changes to existing approved products must be detailed in the form of an application prior to any change being made. This is a requirement of the conditions of approval agreed at the time the product was granted approval. Failure to notify of any changes or discovery of changes made without notification will result in revocation of the approval. It is a condition of the product approval that any changes to the product require authorisation from DWI in advance. Changes can include:
- name or designation of the approved product
- name of the approval holder
- additional site(s) of manufacture
- nature and composition of the product
- nature and source of ingredients, and composition
- manufacturing process
- management system for the manufacture and supply of the product
- method of use or application
- Instructions for Use
Any change, associated to the above, to an approved product must be notified to the DWI Regulation 31 team, so that an assessment can be made. Log into the Reg31 portal, select the product you wish to submit a change for and then click the “submit a change” button.
Administrative Changes
Changes to the details given on the List of Approved Products and the Approval Letter but not affecting the product or manufacturing of the product must be notified to DWI. Changes can include:
- name or designation of the approved product
- name of the approval holder
- any change to the contact details (but not to the manufacturing site)
- rebadging of the product by another supplier only with agreement of the primary approval holder
- changes to the management system
The following information will be required by DWI:
- a completed change request application form
- a completed application form, agreement from primary approval holder and IFU document for rebadged products (See Advice Sheet 2 for guidance on IFU criteria)
- documentary evidence of the change
- a copy of the current approval letter
- a copy of the current and revised Instructions for Use (IFU) document
- declaration that changes are administrative only
A Tier 1 charge is applicable to all administrative changes.
Change to Site of Manufacture
Where the manufacture of a product is going to be relocated or an additional site is to be used, this should be notified to the DWI before any change takes place. The following information should accompany a change application:
- full details of the proposed new manufacturing site, including the full postal address
- date of the proposed move
- details of any changes in the sources of the ingredients used in the manufacture of the product
- full formulation details of the product
- details of any changes in the manufacturing process
- details of the management system for the new site
- confirmation of changes in the IFU, if required
- a copy of your current approval letter
- confirmation of continuation for supply of the approved product should be provided
A Tier 3 charge is applicable for this type of change.
Audit testing of the product manufactured on the new site will be required. The DWI will confirm the test requirements once the application has been evaluated.
Changes to the Approved Product
Changes that directly affect the approved product must be notified to the DWI in advance of the change being made to the product, such changes include:
- raw materials and their supplier
- components and their suppliers
- method of manufacture including components
- application of the product
- quality parameters of the product
The following information should be included in a change application:
- type of change being proposed, together with the reason(s) for the change
- copy of your current approval letter
- original and revised formulation or components, highlighting the changes as a comparative table including:
- trade name
- chemical name
- CAS numbers
- supplier details
- Materials Safety Data Sheets (MSDSs) & Technical Data Sheets (TDS)
- concentrations
- weight % of each component
- surface to volume ratio of wetted components
- revised Instructions for Use (IFU) document if applicable
- relevant changes to management system utilised in product manufacture
- details of changes to the existing manufacturing process
A charge is applicable for this type of change and will be confirmed by the DWI upon receipt of application. Generally, any testing requirements will be associated with a Tier 2 or 3 charge.
Audit testing of the product may be required. The DWI will confirm any test requirements once the application has been evaluated.