New product authorisation

Content:

To place a plant protection product on the Swedish market, the product must be authorised in Sweden. You can apply for a new product authorisation either through zone work sharing or through mutual recognition.

If you want to place a plant protection product on the Swedish market, the product must be authorised by the Swedish Chemicals Agency. In order for the product to be authorised, the active substance must first be approved in the EU.

In the EU Pesticide database you can check if an active substance is approved External link.

Application through zone work sharing

An application for a new product authorisation through zone work sharing is handled in cooperation within different EU zones. Sweden is part of the EU's northern zone, together with Denmark, Finland, Estonia, Latvia and Lithuania. Norway is also part of the northern zone cooperation.

Zone cooperation means that one member state evaluates an application and does a risk assessment for the entire zone. On the basis of that risk assessment, each member state then decides if the plant protection product shall be authorised nationally, in accordance with the application in their own country.

Application through mutual recognition

It is also possible to apply for a new product authorisation in Sweden through mutual recognition. Normally, such an application is made for a plant protection product that is already authorised in a country in the northern zone, but it is also possible to apply for a plant protection product that is authorised in another EU zone.

An application for mutual recognition must apply to the same product and for the same use as the original product authorisation. Moreover, the agricultural, plant protection and environmental conditions, including climate conditions must be comparable between Sweden and the member state where the plant protection product is already authorised (known as the reference member state).

You can apply for mutual recognition if you are a holder of a product authorisation in another member state. Official or scientific bodies and agricultural organisations can also apply if they can show that the use of the product would be of general interest in Sweden.

Application for an additional authorisation

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.

Read more about possibilities to obtain an additional authorisation

Application form and guidance

No later than six months prior to the submission of your application you need to make a notification to us. This enables us to plan for the evaluation. Please use the template in the link below for the notification.

Template to notify intended zonal applications (PDF 152 kB) External link.

To clarify the application and evaluation process, guidance documents and templates have been developed at EU level. There is also a guidance document of the Northern zone, which contains information about the agreements made within the Northern Zone.

Use the form MIP-0031-E to apply for a new product authorisation through zone work sharing (dotx 96 kB) , 93.2 kB.

Use the form MIP-0033-E to apply for a mutual recognition (dotx 97 kB) , 87.6 kB.

You can find a template and instructions here on how to do your application for a new product authorisation (ZIP 2634 kB) External link.

Guidance document for application in the Northern Zone 2021 (PDF 2233 kB) , 2.2 MB.

Guidance document for application in the Northern Zone 2023 (PDF 1778 kB) , 1.7 MB.
May be used from July 2023, must be used from 1 November 2023.

Guidance on birds and mammals risk assessment in the northern zone 2020 (PDF 3516 kB) , 3.4 MB.

Guidance on efficacy data requirements in the northern zone (PDF 3480 kB) , 896.1 kB.

Guidance for application for mutual recognition in Sweden (PDF 253 kB) , 252.7 kB.

Please find further guidance documents on the European Commissions website External link.

Last published 23 August 2023