Requirements for the authorisation holder and importer after the decision

The authorisation holder completes the product’s label for assignment of registration number.

Published

When you apply for authorisation of a plant protection product, you should include a Norwegian draft label with the application. After the Norwegian Food Safety Authority have approved the product, the applicant should correct the draft label to be in accordance with the requirements in the decision letter, and send it back to the Norwegian Food Safety Authority. When the label is in accordance with the decision letter, we will assign the product a unique registration number, which you must add to the completed label. Not until then you may place the plant protection product on the marked.

The authorisation holder should always submit a pdf-copy of the print-ready label with the registration number to the Norwegian Food Safety Authority. We will then add the label to our list of approved chemical and microbiological plant protection products.

The authorisation holder must keep the Norwegian Food Safety Authority informed of the product’s importer

As the authorisation holder of a plant protection product, you need to inform the Norwegian Food Safety Authority about which companies will import the product. You also need to keep us informed if the importer changes.

The importer must register with the Norwegian Food Safety Authority

Enterprises must register with the Norwegian Food Safety Authority in order to import plant protection products to Norway.

The importer must report the imported amount of the plant protection product and pay taxes for imported product

The authorisation holder needs to keep the importers and distributers informed

If the authorisation of a plant protection product is amended or withdrawn, the authorisation holder should keep the importers, distributers and retailers informed.

The authorisation holder shall notify of any potential harmful or unacceptable effects

The authorisation holder shall notify the Norwegian Food Safety Authority of any information that suggests that the plant protection product no longer complies with the criteria’s of approval.

The authorisation holder shall also record and report all suspected adverse reactions in humans, in animals and the environment related to the use of the planet protection product.

This is described in article 56 in the Regulation (EC) No 1107/2009 concerning the placing of plant protection products on the market.

Regulations

Forskrift om plantevernmidler