Authorization of Veterinary Biocidal Products

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

Union authorization

The applicant can apply for a Union authorization for biocidal products which valid in all EU countries. Applications for Union authorisation shall be submitted to the European Chemicals Agency ECHA (www.echa.eu).

National authorisation

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).

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

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.

Legislation:

•    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:

By e-mail: vaistu.registracija@vmvt.lt
 

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.

Current fees for authorisation of veterinary biocidal products can be found here.

Payment details

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" banka LT78 7290 0000 0013 0151 72900 INDULT2X
Luminor Bank AS Lietuvos skyrius 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
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).

Other information

More information can be found on the ECHA website.

Information about chemicals:

https://echa.europa.eu/en/information-on-chemicals

List of approved active substances:

https://echa.europa.eu/en/regulations/biocidal-products-regulation/appro...

The ECHA Helpdesk:

http://echa.europa.eu/contact/helpdesk-contact-form

 

 

 

Published:
2021-10-04
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