Additional trade name
The authorisation holder of a plant protection product authorized in Norway may apply for additional trade name for the relevant product.
The product with the additional trade name is called a clone product. To apply for additional trade name, you have to send an application according to article 45 in the plant protection products Regulation (EC) No. 1107/2009.
What are the requirements for being granted an additional trade name?
An additional trade name may only be granted for products identical with an already authorized plant protection product in Norway (reference product). The only difference allowed between the two products could be the trade name and importer.
Requirements for the application
You can apply by sending us a formal letter. The application should include:
- Name and registration number for the already approved plant protection product (the reference product)
- Your invoice address
- Print-ready draft label for the product with the new trade name (the clone product)
- The following form to confirm that the products are identical: Statement of identity.
Submit the application to postmottak@mattilsynet.no.
After the product has been granted additional trade name
The authorisation holder must ensure that the label and packaging of the clone product and reference product are in accordance.
After the label of the clone product is approved, the clone product will receive a registration number. Not until then, you may place the clone product on the market.
A clone product can only be placed on the market and be used in accordance with the approval of the reference product. The authorisation of the clone product will expire at the same time as the authorisation of the reference product expires. If the authorisation of the reference product is amended, the same will apply for the clone product.
Fees
Mattilsynet will charge you with a fee for evaluating your application of additional trade name. You will find the fee («Andre endringer av administrativ art som medfører merarbeid for Norge») in attachment 1, chapter III, part B in forskrift om betaling av gebyrer for særskilte ytelser fra Mattilsynet (Norwegian).