Application for authorisation
The following provisions apply to products that must be re-evaluated, as the active substance(s) was (were) approved or re-evaluated under the provisions of the Plant Protection Product Directive, and for new productions for which application was sought before 14 June 2011.
Application procedures vary according to whether the product was already authorised in Denmark or whether the product is new to Denmark.
Authorised plant protection products
Where a plant protection product was authorised according to national rules and the active substance/s in it were included in Annex I of the Plant Protection Product Directive for the relevant area of use, a re-evaluation of the product must take place.
There are two deadlines for applicants. Applicants must thus:
1) within six months of the entry into force of the inclusion directive, submit information on the area of use, information on suppliers of the active substance and the technical specification of the active substance and demonstrate access to the Annex II dossier, for example in the form of a 'letter of access' from the data owner, and
2) submit product data in accordance with Annex III (Annex III dossier) cf. Annex 5 to the Danish Pesticides Order no later than two years from the entry into force of the inclusion directive.
If these deadlines are not observed, the enterprise loses the right to import or sell the plant protection product after the effective date of the directive.
New plant protection products
If the active substance/s is/are included in Annex I of the Plant Protection Product Directive for the desired area of use, the application for authorisation of new products must contain product data (Annex III dossier) and active substance data (Annex II dossier) cf. Annex 5 of the Danish Pesticides Order. With regard to active substance data which forms the basis of inclusion of the active substance in Annex I and which is covered by data protection, access to data must be documented (letter of access) or corresponding information submitted. The documentation must be submitted in one batch as described below.
Submission of application and documentation
The Danish Environmental Protection Agency urges all enterprises to submit electronic applications, as far as possible, since this will facilitate processing and simplify the application process. The electronic dossier (in Word, PDF or Caddy format) should be sent in one copy on a CD or DVD with a covering letter to:
Pesticides and Gene Technology
The Danish Environmental Protection Agency
DK-1401 Copenhagen K
Please include the following:
- A covering letter in which the items being submitted, with relevant formats, are clearly stated, including which of the submitted documents are to be sent for efficacy hearing and if relevant for MRL hearing (this material must be submitted on separate CDs/DVDs). The covering letter should be on paper and as a file together with the electronic documentation.
- Detailed instructions for use in Danish and the GAP table (in EU format here)
- The active substance producer (and technical specification/impurity profile if new producer), product producer and product composition
- A list of studies being submitted – with notes on what is new in relation to the EU evaluation (for active substance and product)
- Any other information on existing registration reports/evaluations from other Member States
- In addition, the complete Annex II and Annex III dossiers including a summary dossier (preferably in Word) both for the product and the active substance cf. Annex 5 to the Danish Pesticides Order. If active substance data has already been submitted this must be indicated.
- If the complete dossier is not submitted, the specific reasons must be stated for this (e.g. a statement as to which product is to be used as a basis for extrapolation and why, including ‘comparison’ of product composition/list of properties of constituent components). There must also be a separate explanatory statement or ‘bridging’ studies in relation to efficacy.
CDs/DVDs should be marked with:
- the name of the active substance, the applicant’s name, date and contents (e.g. Annex II dossier) for active substance data
- product name, active substance(s), applicant’s name, date and contents (e.g. Annex III dossier – section 7 – efficacy data) for product data.
- Special Danish requirements for plant protection products:
- Groundwater modelling for Danish conditions in accordance with the framework for environmental evaluation of plant protection products (required if inherent properties, EU evaluation or similar do not completely exclude the risk of groundwater contamination for the active substance and metabolites).
Applications that do not meet the above requirements may be returned.
For further information contact:
EU guidance on re-registration:
EU guidance on preparation of Annex II and Annex III dossiers:
UK guidance for re-registration after inclusion in Annex I: