Procedures and requirements for applications for the authorization of pesticides

Electronic dossiers

Following a request from applicants for a simplification of procedures and with a view to internal rationalisation, The Danish Environmental Protection Agency has now found a safe and practical solution for the electronic storage of dossiers.

From 1. April 2009, only electronic dossiers on CD or DVD will be accepted (Word, pdf, or Caddy format). Paper dossiers must no longer be submitted.

The Danish Environmental Protection Agency urge all applicants, as far as possible, to send electronic applications, as this will considerably reduce the processing time.

Please send applications, enclosing a CD/DVD (or a paper dossier) to:

Pesticides and Gene Technology
Miljøstyrelsen
Strandgade 29
1401 Copenhagen K

Electronic applications should be submitted to Obfuscated Email

Please include the following:

A cover letter in which it is clearly stated what is being submitted and in which format, including which of the submitted documents are to be sent for efficacy hearing and if relevant also MRL (this material must be collected on separate CD/DVDs or in individual files if they are on paper).

CD/DVD/files should be marked with:
- The name of the active substance, applicant’s name, date and content (e.g. Annex II dossier) for active substance data and
- product name, active substance(s), applicant’s name, date and content (e.g. Annex III dossier – section 7 – efficacy data) for product data.

Attached to the cover letter should be information about:

  • detailed instructions for the Danish use and for pesticides, GAP scheme (in EU format )
    GAP table can be found at: http://www.bba.de/english/ap/ecco/manuals/manual-d/man-d.htm see ECCO-Manual D3.
  • The active substance producer (and composition if from a new source or company), product producer and product composition
  • 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 about existing registration reports/evaluations from other ‘northern’ MS
  • a “Draft Registration Report” (implemented for applications submitted after October 2. 2010) .

Read

Guidance document on the presentation and evaluation of dossiers according to annex III of Directive 91/414/EEC in the format of a (draft) Registration Report (SANCO/6895/2009 rev 1 02 October.2009)

The cover letter should be on paper and a scanned/signed copy should be sent electronically with the above documents.

In addition the complete dossier  including a summary (preferably in Word) for the product and the active substance(s) must be submitted.

See Executive Order with data requirements at: https://www.retsinformation.dk/Forms/R0710.aspx?id=12666#B5

If active substance data have already been sent in the date should be stated  and the date for subsequent updates and, if relevant, which product they were submitted with. If not submitted previously, documentation must also be submitted electronically with the application.

If the complete dossier is not submitted, the specific reasons must be stated e.g. a statement as to which product data is to be extrapolated and a reason 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.