How to apply?

How to apply?

Find the applicable type of application by answering one of the questions below.

1. Start

   1. The registration manual informs you about the application processes. 'How to apply?' will lead you to the relevant application type.

   2. Step 1What type of authorisation does your application concern?

      If you are looking for information about the authorisation of plant protection products or the active substances these products are containing, please continue with step 2 and further of this guide on 'how to apply'.

      If you don’t want to apply for the authorisation of a plant protection product or an active substance contained in those products, you might be interested in one of the items listed below.

      • Application for MRL
      • Application for adjuvants (art. 58)
      • Export certificate
      • Request for information on animal testing
      • Equivalence of an active substance
      • Immediate notification of harmful of unacceptable effects
      • Annual notification of new information

   3. Step 2Is the product not (yet) authorised in the Netherlands?

      If you want to release a plant protection product on the Dutch market, the product must be authorised by Ctgb.
      
      To obtain authorisation for a plant protection product, you can apply for:

      • new product authorisation via the zonal application (including products based on low risk substances)
      • If your product is already authorised in another EU member state , it is possible to apply for a new product authorisation through mutual recognition
      • If the application concerns a plant protection product with at least one new authorisation in the Netherlands it check the possibility to use the fast track procedure 
      • If your product is already authorised in another EU member state and it is identical to a product that is approved in the Netherlands, it is possible to apply for a parallel trade permit in the Netherlands
      • If an identical product is already authorised in the Netherlands and you have permission of the holder of a product authorisation, you might be interested to apply for a derived authorisation

      If the Active Substance is approved but classified as a Candidate for Substitution, a product application with this Active Substance will be preceeded by an evaluation of available alternatives. Therefore you have to add to your application the form for:

      • Comparative Assessment

   4. Step 3Is the product already authorised in the Netherlands ?

      If the product is already authorised in NL and you are the holder or represent a holder of a product authorisation, you might be interested to apply for:

      • re-registration of a product authorisation
      • renewal of a product authorisation
      • change to a product authorisation
      • immediate notification of harmful of unacceptable effects
      • annual notification of new information
      • withdrawal of a product

      If the product is already approved, but not for the use in question and the extension of uses concerns a ‘minor use’,  it is possible to apply for:

      • extension with minor uses. Under Article 51 of the PPPR 1107/2009 also authorisation holders and growers or grower organisations can apply for an extension with minor uses.

      If an identical product is already authorised in NL and you have permission of the holder of a product authorisation, you might be interested to apply for:

      • a derived authorisation
      • renewal of a derived authorisation

      If your product is authorised in another Member State in the EU and it is identical to a product that is approved in the Netherlands, it is possible to apply for:

      • a parallel trade permit in the Netherlands

      If your product is authorised by mutual recognition, and the original expiry date has been set before the date of expiry of the active substance +1 year, your authorisation can be extended administratively, by Form NLWERGV.

      Do you wish to introduce a new source for active substance (or additive/adjuvant) or for the formulation of an already authorised product? You might be interested in 'Minor or administrative changes'.

   5. Step 4Is the Active Substance not approved?

      For a zonal application the status of the Active Substance is important. Only products with approved Active Substances can be authorised via the zonal application.
      
      If the Active Substance is NOT approved you might be interested to apply for:

      • an active substance approval

   6. Step 5Do you need to apply for a derogation ?

      You can apply for a derogation of the prerequisite to have the plant protection product authorised in an emergency situation or for research and development.

      • Derogation for an emergency situation (art. 53);
      • Derogation for research and development (art. 54)

   7. Step 6Do you apply for product authorisation with minor uses ?

      You are interested in a product authorisation with minor uses. The product is yet not authorised in NL nor in any other MS. You may want to apply for:

      • new product authorisation with core assessment of minor uses
        • Zonal application NL=RMS
        • Zonal application NL=CMS

      The product is not authorised in NL but authorised elsewhere in the zone with core assessment of minor uses. You may want to apply for:

      • new product authorisation via mutual recognition

      The product is authorised in NL and you want to market this product in more EU member states. You may want to apply for:

      • an extension with minor uses via zonal application

      The product is authorised in NL and you want to market this product in the Netherlands only. You may want to apply for:

      • an extension with minor uses via national procedure NLKUG B (art. 51)