Additional authorisation for a plant protection product

Content:

It is possible to obtain an additional authorisation in order to put an already authorised plant protection product on the market under another trade name. You can obtain such an additional authorisation by applying for a new product authorisation.

If you want to put an already authorised plant protection product on the market, under another trade name, there are two alternatives. You can apply for a new authorisation or for a parallel trade permit.

Read more about a parallel trade permit

Under certain conditions, you may apply for a new authorisation based on an existing authorisation, without performing a new risk assessment. The new authorisation cannot be extended or amended, as compared to the existing one. However, it is possible to entirely remove one or several areas of use.

The risk assessment shall be in accordance with the guidance for risk assessment that applies when submitting the application. An authorisation shall fulfill the legislation applicable at the time of the decision.

In brief, the conditions that must be fulfilled are:

  • No new legislation that impacts the authorisation is applicable.
  • No new guidance for the risk assessment is applicable.

Content of your application

The application for a new authorisation based on an existing authorisation must contain:

  • An application form including information about which existing product you want to refer to.
  • A formal declaration that no new guidance other than the one used in the risk assessment of the existing product shall apply.
  • A formal declaration that no new legislation since the decision of the existing product is applicable.
  • A GAP table containing the intended uses that you want to apply for.
  • If applicable, a Letter of Access for data protected test and study reports.
  • If applicable, a Letter of attorney granting access to confidential information, e.g. the product's composition.

Application fee

The application fee will be the same as for an ordinary application for a new product authorisation. The fee will be invoiced and shall be paid in conjunction with the submission of your application.

If we conclude that the conditions, listed above for granting an authorisation without performing a new risk assessment, are not fulfilled, we will contact you. You will then have the opportunity to either withdraw your application or submit supplementary information.

When the process for a product authorisation is finalised, we will decide whether it is justified to reduce the application fee . Please note, the fee will not be lower than 20,000 SEK, if we have made some assessment. However, if you withdraw your application before a formal assessment of your application has started, the fee may be further reduced.

Last published 26 August 2020