New product authorisation

Content:

Application through zone work sharing
Application through mutual recognition
Application for an additional authorisation
Application form and guidance

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.

Already before you submit your application it is valuable to exchange information and initiate a dialogue between you and the zonal rapporteur. Preferably, this can be done in the form of a pre-submission meeting. The purpose of the meeting is to discuss potential problems and facilitate the process of the submission and evaluation of the application. When the Swedish Chemicals Agency is zonal rapporteur, we would like you to contact us by mail bkarendeplanering@kemi.se in order to organize a pre-submission meeting. The meeting is free of charge. Please, contact us at least three months in advance.

Application through mutual recognition

It is also possible to apply for a new product authorisation in Sweden through mutual recognition. An application in Sweden for a mutual recognition is based on an authorisation from another EU member state.

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). Within the Northern Zone the conditions are assumed to be almost comparable. If the conditions relevant for Sweden are not assessed in the original product authorisation the application can be supplemented with this information.

You can apply for mutual recognition if you are the 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.

Already before you submit your application it is valuable to exchange information and initiate a dialogue. Preferably, this can be done in the form of a pre-submission meeting. The purpose of the meeting is to discuss potential problems and facilitate the process of the submission and evaluation of the application. We would like you to contact us by mail bkarendeplanering@kemi.se in order to organize a pre-submission meeting. The meeting is free of charge. Please, contact us at least three months in advance.

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.

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.