eugo.gov.si Apply for Research & Development Permit : Slovenia

Organization : Ministry of Public Administration
Facility : Apply for Research & development permit
Country : Slovenia
Website : http://eugo.gov.si/en/permits/permit/12444/showPermit/

Get Research & Development Permit :

** Trials or test for the research or development purposes which include the emission of the non-registered plant protection product (PPP) into environment or include prohibited use of PPP may be implemented only on the basis of the issued research and development permit.

Related : EUGO Slovenia Ministry of Public Administration How can close a business : www.statusin.org/9578.html

** The permit may restrict the consumed quantity and discussed areas and determine additional conditions for the prevention of harmful impacts on the health of people and animals and unacceptable harmful environmental impacts.

** The competent authority decides on the research and development permit.
** An applicant lodges the application with attachments with the competent authority.

Required documents :
** Extract from the court register or decision on the notification of the activity
** Evidence of pursuit of research activities

** Agency contract
** Safety data sheet for PPP
** Exact plan and the location of the experiment where the PPP will be used

** Statement of the destruction of agricultural products obtained during experiments, if necessary
** Description of the analytical method for residue

Legal protection :
1. Judicial remedy : Appeal
2. Competent authority : Ministry of Agriculture, Forestry and Food

Registration of plant protection products (PPP) :
** An applicant who wants to trade in PPP requests for the registration by himself or through a representative in each individual Member State where he plans to trade in PPP.
** The competent authority decides on the registration of PPP on the basis of the consent of the authority competent for chemicals.

The request must include the following information :
** list of the foreseen use in each zone and Member States where the applicant lodged or intends to lodge a request;

** a proposal which Member State should assess the request for the respective zone. In the case of the request for the use in greenhouses, treatment after the harvesting, treatment of empty warehouses and treatment of seeds, only one Member state is proposed to assess the application taking into account all suitable zones,

** copies of all registrations already issued for this respective PPP in the Member State; and

** if appropriate, the copies of all resolutions of Member States assessing the equivalence.
** Upon submitting a request, the applicant may demand that some information and some parts of documentation remain confidential and physically separates this information.

** An application for the registration must be drawn up in the Slovenian language, whereas the documentation attached to the application may be in the Slovenian, English or German language or exceptionally also in other official language of the European Union, if the competent authority consents.

Required documents :
** For the PPP in question, complete documentation and the summary of each item from the regulation on the data required for PPP

** For each active substance, safener or synergist in PPP, complete documentation and the summary of each item from the regulation on the data required for the active substance, safener or synergist

** For each experiment or study which includes vertebrate, the justification of measures taken to prevent animal testing, and duplication of experiments and studies on vertebrates
** Reasons why the submitted reports on experiments and studies are required for initial registration or changes in the conditions for registration

** If appropriate, copy of request for maximum residue levels referred to in Article 7 of Regulation (EC) No 396/2005 or justification why the data has not been included

** Assessment of all data submitted in accordance with Article 8(1) of Regulation (EC) No 1107/2009
** Draft label
** Applicants send a complete file or its summary to other Member States at their request

** Applicants also submit a complete list of studies submitted in accordance with Article 8(2) of Regulation (EC) No 1107/2009, and a list of reports on experiments and studies which require data protection in accordance with Article 59 of Regulation (EC) No

** At the request of a Member State, applicant provides samples of PPP and analytical standards of their components

About the EUGO portal :
This page gives all the information about The EUGO portal that a business person will need. The Eugo Slovenian portal is a state business point that helps foreign business entities from the EU, EEA Member Countries and the Swiss Confederation who want to do business in Slovenia.

The EUGO portal provides accurate information about the procedures required for performing business activities in the Republic of Slovenia.

This method helps Slovenia meet the requirements of European directives and enables simpler and friendlier operations in the market of the Republic of Slovenia.