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Who, when and where

After 14 June 2011 there is no change to the principle governing who must apply, when to apply and the granting or rejection of authorisation by individual Member States. What has changed is that the EU is now divided into three zones for the purposes of cooperation between Member States on the evaluation of new applications for authorisations.

Who can apply

The company wishing to place the product on the market must apply for authorisation. The application for authorisation to place a product on the market in Denmark is free of charge.

When to apply

You may only begin the application process in a Member State such as Denmark after the approval of the active substance and its inclusion on the EU positive list (the Authorisation Regulation). If the EU refuses an active substance, it is forbidden to sell or market the substance in the European market. This is the case whether the application was made before or after 14 June 2011.

There is one instance in which the application process may be started before an active substance has been included on the positive list. This relates to the 2 ½-year time limit for the EU’s evaluation of a new active substance. If this period is exceeded, you may apply for a provisional authorisation of your product before the active substance has been fully evaluated.
Read more on provisional authorisations

Where to apply

As before, you must apply for product authorisation in the country or countries where you wish to place your product on the market. This also applies to the new approval zones, where the evaluation of new products and re-evaluations are undertaken for the zone. The EU is a single zone with regard to plant protection products for use in greenhouses, as post-harvest treatments, for treatment of empty storage rooms, or for seed treatments.

Denmark in the North zone

Denmark has been placed in the North zone together with Estonia, Finland, Latvia, Lithuania and Sweden. Norway will be part of the cooperation in the zone. The Central zone is made up of Austria, Belgium, the Czech Republic, Germany, Hungary, Ireland, Luxembourg, the Netherlands, Poland, Slovakia, Slovenia, and the UK. The South zone consists of Cyprus, France, Greece, Italy, Malta, Portugal and Spain.

Choice of country

You may apply in as many countries and zones as you wish. There are two types of authorisations for which you can apply: zonal authorisation, or mutual recognition – both within a zone and between zones.

Guidelines have been developed for collaboration on common procedures for authorisations within each zone. Steering committees have been set up to ensure cooperation between respective authorities.

Links

Guidelines on collaboration and in particular re-evaluations ind the North zone

Guidance document on zonal evaluation and mutal recognition under Regulation (EC) No 1107/2009
Guidance document for evaluation of efficacy in the North zone