Authorisation of a copy product

A copy is an extra trade name for a plant protection product already authorised in Denmark.

The authorisation holder of the already authorised plant protection product is entitled to apply for an additional trade name or give permission to another company to become authorisation holder of the product with the new trade name.

Requirements for the application procedure

The application must contain following information:

a) name and address of the applicant for the extra trade name
b) name of the plant protection product to be authorised
c) draft of Danish label
e) name and registration number of the reference product
f) permission from the authorisation holder of the reference product to another authorisation holder (Letter of Access).

Download application form

The application can be emailed (pestider@mst.dk) or submitted to:

The Environmental Protection Agency, Pesticides 
Tolderlundsvej 5
DK-5000 Odense C

Processing time

Up to 45 days.

Fees

As of 1 January 2014 fees for processing applications for plant protection products were introduced. Read more on fees.

Note that fees will also be charged for the renewal of a copy.

When the reference product is in the process of being renewed, The Danish EPA will ask the authorisation holder to submit an application for renewal, and fees will be charged upon receipt of the application.

When authorisation is granted

An authorised plant protection copy product may only be marketed and used in accordance with the authorisation of the reference product. 

A copy will expire at the same time as the reference product. This will also apply if the authorisation of the reference product is withdrawn for reasons other than safety. 

A copy may be withdrawn if the authorisation conditions are no longer met, that is in the event that the authorisation of the reference product is withdrawn for safety or effectiveness reasons. 

A annual fee of DKK 500 per authorized product is payable, as well as a pesticide tax imposed by The Danish Customs and Tax Administration.

Regulations

 A copy is authorized in accordance with article 33 under Regulation (EC) No 1107/2009.