State Food and Veterinary Service is assigned to perform the evaluation of authorisation applications for biocidal products of the following product types:
• Type 3. Veterinary hygiene (products intended for veterinary hygiene purposes, e.g. disinfectants, disinfecting soaps, oral or corporal hygiene products or with anti-microbial function, as well as products used to disinfect the materials and surfaces associated with the housing or transportation of animals);
• Type 4. Food and feed area (products intended for disinfection of equipment, containers, surfaces or pipeworks involved in production, transportation, storage or consumption of animal feed or drinking water);
• Type 14. Rodenticides (products that are intended only for animal housing and transportation);
• Type 18. Insecticides, acaricides and products to control other arthropods (only those intended for veterinary hygiene purposes to use in the area of animal housing and transportation);
• Type 19. Repellents and attractants (only those intended for veterinary hygiene purposes to use directly on the skin or in the area of animal housing and transportation);
• Type 22. Embalming and taxidermist fluids (products that are intended for disinfection and preservation of animal corpses or parts thereof).
In accordance with Regulation (EU) No. 528/2012 the following authorisation procedures apply to biocidal products:
• Union authorisation
• National authorisation
• Mutual recognition procedures
• Simplified authorisation
Applications for Union authorisation shall be submitted to the European Chemicals Agency (ECHA).
Applicant may apply for Union authorisation for biocidal products which have similar conditions of use across the Union with the exception of biocidal products that contain active substances that fall under Article 5 and those of product-types 14, 15, 17, 20 and 21.
The Union authorisation will be available at different stages depending on the product-type for products containing active substances already on the market as follows:
• from 1 September 2013, to biocidal products containing one or more new active substances and biocidal products of product-types 1, 3, 4, 5, 18 and 19
• from 1 January 2017 for product-types 2, 6 and 13
• from 1 January 2020 for the remaining product-types.
The Union authorisation is not available for product-types 14, 15, 17, 20 and 21, or if the product contains active substances which meet the general exclusion criteria (e.g. substances in CMR categories 1A and 1B).
The applicant can submit application for the National authorisation just in one Member State.
In the Republic of Lithuania veterinary biocidal products are authorised by State Food and Veterinary Service (SFVS). SFVS is responsible for the authorisation of biocidal products for veterinary use of types 3, 4, 14, 18, 19 and 22 only products intended for use in the areas in which animals are housed, kept or transported, as well as areas for animal feed storage etc.
Mutual recognition authorisation
Mutual recognition of authorisation in accordance with Regulation (EU) No.528/2012 could be:
• mutual recognition in parallel
• mutual recognition sequence
• Mutual recognition in parallel means, that mutual recognition of authorisation for biocidal product which is not yet authorised in any member state can be applied while the application for first authorisation is being processed. Mutual recognition in sequence which means, that the authorisation is applied for a product which already has been given the first authorisation in another EU country.
Simplified authorisation is applicable in accordance with Articles 25, 26 of Regulation (EU) No. 528/2012.
Important information for biocidal product authorisation holders
Article 95.1 of Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012 concerning the making available on the market and use of biocidal products (OJ L 167, 27.6.2012, p.1) requires that substance and/or product supplier should be included into the list under this article („Article 95 list“) or has a Letter of Access of already included person.
European Chemicals Agency published the list in its web site on 24th October 2014:
Part 2 of mentioned Article 95 from 1st September 2015 bans making available on the market veterinary biocidal products when requirements of this article are not fulfilled. To implement this provision from 1st September 2015 will cancel veterinary biocidal product authorisation certificates in relevant cases.
Veterinary biocidal product authorisation holders are suggested to check if requirements concerning the ,,Article 95 list“ are fulfilled. In case of non-compliance measures to include substance/product supplier into the list, or to get a Letter of Access from already included persons should be considered, or biocidal product active substance supplier should be chosen from those in the list.
• Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012 concerning the making available on the market and use of biocidal products.
• Resolution No 686 of the Government of the Republic of Lithuania of 24 July 2013 regarding implementation of Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012 concerning the making available on the market and use of biocidal products.
• Rules on authorization and registration of biocidal products approved by the Order No. 421 (14 August, 2002) of the Minister of Health Care of the Republic of Lithuania.
AUTHORISATION OF BIOCIDAL PRODUCTS FOR VETERINARY USE UNDER THE TRANSITIONAL MEASURES
State Food and Veterinary Service is responsible for authorisation of biocidal products for veterinary use:
PT3, PT4, PT14, PT18, PT19, PT22.
Applicant should submit application form and dossier of biocidal product:
Nacionalinis maisto ir veterinarijos rizikos vertinimo institutas
J. Naujalio g. 21b, 48332 Kaunas, Lietuva
By e-mail: email@example.com
AUTHORISATION FEES OF BIOCIDAL PRODUCTS UNDER TRANSITIONAL MEASURES
State Fees applicable in Lithuania for the authorisation of veterinary biocidal products were adopted by the Government of the Republic of Lithuania on 15 December 2000 (Decision No. 1458). Latest amendments were adopted on 15 December 2014 (Decision No. 1442) and amended fees came into effect on 1 January 2015.
Fees are payable to any of the following accounts of the State Tax Inspectorate under the Ministry of Finance of the Republic of Lithuania:
|Bank||Account No. (IBAN)||Bank code||SWIFT|
|AB "Citadele" bankas||LT78 7290 0000 0013 0151||72900||INDULT2X|
|Luminor Bank AB||LT74 4010 0510 0132 4763||40100||AGBLLT2X|
|AB SEB bankas||LT05 7044 0600 0788 7175||70440||CBVILT2X|
|AB Šiaulių bankas||LT32 7180 0000 0014 1038||71800||CBSBLT26|
|Danske Bank A/S Lietuvos filialas||LT74 7400 0000 0872 3870||74000||SMPOLT22|
|AB "Swedbank"||LT24 7300 0101 1239 4300||73000||HABALT22|
|UAB Medicinos bankas||LT42 7230 0000 0012 0025||72300||MDBALT22|
Beneficiary: State Tax Inspectorate under the Ministry of Finance of the Republic of Lithuania
Beneficiary‘s address: Vasario 16-osios g. 14, 01514 Vilnius, Lithuania
Reference number: 5742 is mandatory to indicate alongside to payment details (product name, procedure type: authorisation/mutual recognition/renewal/variation).