The case processing time at the Danish Environmental Protection Agency is considered to begin upon receipt of all the required information from the private individual/company/authority. For cases with fixed application deadlines, the target processing time commences on expiry of the application deadline. The processing times given below indicate the maximum timeframe within which most cases will be processed. For cases where the Danish Environmental Protection Agency is unable to meet the target processing time, the private individual/company/authority will be informed of this and given an indication of the anticipated time for completion of processing. In general, all cases will of course be processed as quickly as possible. This means that a number of cases will be processed sooner than the specified processing time. The Danish Environmental Protection Agency’s various types of administrative cases are not comparable. Consequently, the target times for processing vary from one type of case to another.
Authorisation of a new plant protection product in accordance with the Pesticide Regulation No 1107/2009
Target
Application for authorisation where Denmark is zonal RMS
1-1½ years
Application for mutual recognition, where another Member State in the North zone has acted as zonal RMS
4 months
Application for mutual recognition, where a Member State outside the North zone has acted as zonal RMS
Confirmation of application for authorisation as complete
6 weeks
Application for authorisation of a product containing a low-risk active substance.
4-10 months
Application for a parallel trade permit
45-55 days.
Authorisation in respect of other types of applications concerning plant protection products
Application to carry out experimental testing
3 months
Application for a derogation permitting the use of unapproved agents
Up to 6 months
Application for extended use, formulation changes and minor uses (formerly off-label)
Up to 1½ years, depending on complexity and the need for external consultation
Permit for the sale of toxic substances
2 weeks
Recognition of completed course on toxic substancesIn connection with the commercial spraying of highly toxic pesticides
4 weeks
Permit for spraying pesticides from aircraft
Authorisation of a plant protection product under transitional provisions (new and existing products)
Application for authorisation of products containing active substances which are new to Denmark
1½-2 years
Application for authorisation of new products containing active substances which have already been approved (me-too products)
Application for renewal of authorisation following inclusion in Annex 1
Within the time frame of the inclusion directive
3-6 months
Important points - the new Pesticides Regulation
Application form for mutal recognition and zonal applications (word)Pre-notification form for planned zonal applications (word)Guideline on collaboration and in particular re-evaluations ind the North zone
Guidance document on evaluation of efficacy in the North zone
Guidance document on zonal evaluation and mutal recognition under Regulation (EC) No 1107/2009Application form for parallel trade permits
Pesticide Regulation No 1107/2009Classification Regulation (CLP) No 1272/2008Dangerous Preparation Directive 1999/45Labelling Regulation No 547/2011
Danish legislation can be found at www.retsinfo.dk and www.lovtidende.dk EU legislation is available at http://eur-lex.europa.eu