Guidance for post-authorization changes for biocides: Sample templates
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Change in product ownership, merger or buyout
You can use this sample letter in cases where a market authorization is being divested, such as during a:
- buyout or merger
- change in product ownership
[Official letterhead of the comparison biocide market authorization holder]
To whom it may concern:
RE: (Primary brand name of biocide: Identification number XXXXXXXX)
We confirm that the ownership of the biocide (primary brand name: identification number XXXXXXXX) is being transferred to (name of new market authorization holder). We acknowledge that Health Canada will issue the same identification number to (name of new market authorization holder).
We confirm that we have provided (name of new market authorization holder) with the most complete and up-to-date biocide application information, including the master formula of the biocide, to support the maintenance of product labels and enable consistency with that of the comparison biocide, if applicable.
(Authorized signature: name of divesting market authorization holder)
(Signee's name and title)
Change to align with comparison biocide
[Official letterhead of the comparison biocide market authorization holder]
To whom it may concern:
RE: (Primary brand name of licensee biocide: identification number XXXXXXXX)
(Licensor company name) hereby confirms that a major change to (comparison biocide's primary brand name: identification number XXXXXXXX):
Select one:
(A) resulted in an amendment to its master formula and we have provided (licensee company name) with the updated master formula for this biocide in order to support the major change application filed by (licensee) for (licensee biocide's primary brand name).
(B) did not result in an amendment to its master formula
We confirm that we have provided (licensee) with the most complete and up-to-date application information to support the filing of a complete application for a market authorization and support the development and maintenance of biocide labels for the biocide in the application based on comparison.
As the licensor, we acknowledge our responsibility to ensure that:
- biocide labels are kept up-to-date and any safety and efficacy updates are communicated to the licensee upon approval
- any post-authorization updates to the master formula are communicated to the licensee
(Authorized signature: licensor)
(Signee's name and title)