To release a plant protection product on the Swedish market, the product must be authorised in Sweden. You can apply for a new product authorisation through zone work sharing or through mutual recognition. You can also apply for a parallel trade permit.
New product authorisation
If you want to release a plant protection product on the Swedish market, the product must be approved by the Swedish Chemicals Agency. In order for the product to be authorised, the active substance must first be approved in the EU.
You can apply for a new product authorisation either through zone work sharing or through mutual recognition.
Application through zone work sharing
An application for a new product authorisation through zone work sharing is handled within the cooperation in place in different EU zones. Sweden is part of the EU's northern zone, together with Denmark, Estonia, Latvia and Lithuania. Norway is also part of the northern zone cooperation.
Zone cooperation means that a member state evaluates the basis for an application and does a risk assessment for the entire zone. On the basis of that risk assessment, each member state then decides whether the plant protection product is to be authorised after the application has been made in their own country.
Application through mutual recognition
It is 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 for the same product and for the same use as the original product authorisation. Moreover, the agricultural, plant protection and environmental conditions, including climate conditions, in Sweden and the member state where the plant protection product is authorised (known as the reference member state) must be comparable.
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 its use would be of general interest in Sweden.
Parallel trade permit
You may obtain a parallel trade permit in Sweden for a plant protection product authorised in another EU country if it is identical to a product already authorised in Sweden. The holder of a parallel trade permit may import and sell such a product on the Swedish market.
A parallel trade permit applies for the same period as the authorisation of the product already authorised in Sweden (the reference product). The areas of use and other conditions applying to the reference product also apply to the product covered by the parallel trade permit.
A plant protection product is regarded as identical to the reference product if
- it has been manufactured by the same company or an associated company or else under licence using identical manufacturing processes
- it has identical active substances, safeners and so-called synergists in the specification, and identical concentration levels and form of preparation
- it contains the same or comparable additives and has the same packaging or shape that guarantees the safety of the product as regards human or animal health or the environment.