Back-to-back
If a company wishes to register an number of identical product
applications (the formulation, application rate, user group and
pest and usage area etc must be identical) at the same time or wish
to register an identical product to one that is already approved,
with only the product name and perhaps the approval holder and the
marketing company being different then this can be done
"in-house" via the Back-to-Back route. The procedure for
applying via the Back-to-Back route is as follows:
- Applicants should send a letter to HSE detailing the name of
the product (the original parent product on which the
identical Back-to-Back is based must have been originally
approved within the previous 12 months) they wish to
gain approval for as well as the proposed approval holder and
marketing company, the name and HSE number of the currently
approved product they wish to copy and, if necessary, a letter of
authorisation from the approval holder of the currently approved
product.
- Once HSE have this information a fee will
be invoiced.
- Letters of authorisation from approval holders of the
currently approved product (if required). Companies wishing to
gain approval for an identical product to an approved product
from another company must seek authorisation to do so. The
approval holder of the approved product must write to HSE to
authorise access to their product details.
- Once HSE have this information, a draft schedule is sent to
the company for agreement. At this stage we request a copy of the
draft label if one has not already been
provided.
- Upon receipt of the applicants agreement and once Ministerial
consent is obtained, a Notice of Approval and final schedule is
issued to the approval holder.
