Amendment of an authorisation

Published 01.06.2015     Modified 29.11.2019

The authorisation holder may apply for amendments of their authorisation. This could be changes in use, or administrative changes.

In this text, you can read more about:

  1. Amendments of a product’s area of use requiring a zonal evaluation (label extensions)
  2. Minor use extensions
  3. Amendments not requiring a zonal evaluation and administrative changes
  4. Transfer of products
  5. Grace periods after amendments

Amendments of a product’s area of use requiring a zonal evaluation (label extensions)

Amendments of a product’s area of use requiring a zonal evaluation could be additional cultures, additional pests or amended PHI.

These types of amendments must be applied and assessed as a zonal evaluation (according to article 33 in the plant protection products Regulation (EC) No. 1107/2009), and will follow the same process as evaluating a new plant protection product.

Read more about new plant protection products. 

You can also read more about amendments in the latest edition of the Guidance document on work-sharing in the Northern Zone (guidance A1) from our overview over guidance documents.

Minor use extensions

A minor use extension allows you to use an already approved plant protection product for other, «minor» uses.

Read more about minor use. 

Administrative changes and amendments not requiring a zonal evaluation

Amendments not requiring a zonal evaluation should be applied according to article 45 in the plant protection products Regulation (EC) No. 1107/2009.

Such changes could for instance be:

  • Amending the plant protection product’s name
  • Amendments of the product’s label layout
  • Changes in packaging
  • Limitations in the product’s area of use
  • Amendments of production place

The application should be sent as a formal letter to the Norwegian Food Safety Authority, or as an attachment in an e-mail to postmottak@mattilsynet.no. The applicant will be charged with a fee after the assessment.

Transfer of products

To transfer a product from one authorisation holder to another, both parts should send a formal written confirmation to postmottak@mattilsynet.no. We need to be informed of when the change enters into force, who the importer is and an updated label if relevant.

We will charge you with a fee for transferring products. You will find the fees for «Andre endringer av administrativ art (f.eks. produktnavn) som medfører merarbeid for Norge» in attachment 1, chapter III, part B in forskrift om betaling av gebyrer for særskilte ytelser fra Mattilsynet (Norwegian). If there are several products being transferred in the same letter, you will be charged with one fee per five transfers.

Grace periods after amendments

After an approval of a plant protection products are withdrawn or amended, the Norwegian Food Safety Authority may grant a grace period for disposal, storage, placing on the market and use of existing stocks.

Read more about grace periods.

 

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