Authorisation for the placing on the market and use of a plant protection product

Process description

1. Service requests
   E-mail
   • the customer shall send the documents to the e-mail address of the State Plant Protection Service or to the official electronic address.
   • documents must be signed with a secure electronic signature.
   
   Mail
   • the customer sends the documents by mail.
   
   In person
   • the customer arrives at the State Plant Protection Service and submits documents.
   
   Documents to be submitted:
   1. Completed application form.
   2. An application for authorisation in accordance with Article 33 of Regulation (EC) No 1107/2009 shall be accompanied by the following documents:
   • complete documentation and a summary of each of the data requirements for the plant protection product concerned;
   • for each active substance, safener and synergist contained in a plant protection product, complete and summary documentation for each point of the requirements for the active substance, safener and synergist concerned;
   • justification for each test or study involving vertebrate animals for measures taken to avoid animal testing and repeated testing and testing on vertebrate animals;
   • the justification why the submitted test and study reports are necessary for the granting of the first authorisation or for amending the conditions of the authorisation;
   • a copy of the application for a maximum residue level, as referred to in Article 7 of Regulation (EC) No 396/2005, or the reasons for not providing such information;
   • draft labelling.
   3. An application for authorisation in accordance with Article 40 of Regulation (EC) No 1107/2009 shall be accompanied by the following documents:
   • a copy of the authorisation granted in the Member State of reference and a translation of the authorisation into Latvian;
   • an official statement that the plant protection product is identical to that for which authorisation was issued in the reference Member State;
   • complete or summary documentation in accordance with Article 33(3) of Regulation (EC) No 1107/2009;
   • the assessment report of the reference Member State containing information on the assessment of the plant protection product and the relevant decision.
   
   The State Plant Protection Service shall:
   • review the documents submitted;
   • carry out an assessment of the authorisation;
   • take a decision and issue an authorisation for the placing on the market and use of a plant protection product;
   • register the plant protection product in the Register of Plant Protection Products;
   • issue a marketing authorisation.

2. Payment for service
   The service shall be paid in accordance with the invoice of the State Plant Protection Service, issued on the basis of points 36 and 37 of Annex 2, or paragraph 39, or paragraph 40 of Cabinet Regulation No 493 of 12 July 2012, “Price List of Payment Services of the State Plant Protection Service”:
   • for an application in accordance with Article 33 of Regulation (EC) No 1107/2009:
   - EUR 16363,01 (if Latvia is in the area of the draftsman of the assessment)
   - EUR 2845,74 (if Latvia is a participating country)
   • for an application pursuant to Article 40 of Regulation (EC) No 1107/2009, EUR 2845,74
   
   Service Fee Properties
   Consignee: State Plant Protection Service
   Registration No 90000042982
   Account No. LV47TREL2160320005000
   Bank: Treasury
   BIC: TRELLV22

3. Payment of state fee
   In accordance with Section 7, Paragraph 2 of the Plant Protection Law, the State fee of EUR 42,69 shall be paid for registration and maintenance of a plant protection product in the register, on the basis of Cabinet Regulation No. 139 of 20 February 2007, Regulations regarding the State fee rates and the procedures for payment thereof regarding plant protection products register, plants subject to phytosanitary control and plants section 2 of the register of persons involved in the circulation of products and the register of labels for wood packaging.
   
   State Fee Properties
   Consignee: Treasury
   Registration No 90000050138
   Account No. LV37TREL1060160919900
   Bank: Treasury
   BIC: TRELLV22
   Revenue classification code: 9.1.9.9.
   Objective: On the sorting of the register of plant protection products

4. Receipt of services
   Mail
   • the customer receives a decision and registration certificate to the specified postal address
   
   In person
   • customer arrives at the State Plant Protection Service and receives a decision and registration certificate