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Notifying National Public Health Centre under the Ministry of Health, when making available on the Lithuania market biocidal product in accordance with simplified procedure in another EU Member State
(2016-10-26)
 
An applicant who received a simplified authorisation in another EU Member State and is intending to place the biocidal product on the LT market must prenotify LT CA about the upcomming notification. Prenotification is a free form letter on behalf of the applicant that has to be send by post directly to the National Public Health Centre under the Ministry of Health. A content of the prenotification is: (a) prospective date on when an actual notification will be submitted in R4BP (at least 1 week before submission);   (b) name and type of biocidal product authorized according simplified procedure, (c) asset number of authorized biocidal product in R4BP; (d) name and contact details of authorization holder, (e) name and contact details of prospective case owner/applicant.  
After the prenotification is received, National Public Health Centre in advance will inform an applicant about payable taxes. Taxes must be paid in 30 days. Information regarding taxes will be sent to applicant by an e-mail. If taxes are not paid by the end of the day 30, CA will reject the notification.
 
Submitted notification in R4BP must contain: (a) free form letter on behalf of the applicant, stating product  trade name and type, asset and national authorization; (b) Summary of  product charecteristics (SPC) in Lithuanian and  English; (c) Safety data sheets (SDS) in Lithuanian; (d) Lithuanian and English translation of authorization certificate, issued by referente MS.
 
Over a next 30 days, after notification in R4BP has been submitted, Lithuanian Competent Authority will check and evaluate, and sent its comments on documents to the applicant. After 30 days period LT CA will inform an applicant on R4BP and by an e-mail by sending approval/disapproval letter. If notification is accepted, then CA will upload all the relevant information on the prduct in their National registration system for biocidal products. 


Regarding the change of harmonized classification and labelling of anticoagulant substances

It has been proposed to revise  the harmonised classifications of nine anticoagulant active substances (brodifacoum, bromadiolone, chlorophacinone, coumatetralyl, difenacoum, difethialone, flocoumafen, warfarin, warfarin sodium) included in part 3 of Annex VI to the Regulation 1272/2008. The hazard class Toxic to Reproduction Cat 1A or 1B with concentration limit of 0.003% will be added to these substances. This means that only those biocidal products with active substance concentration limit of 0.003% or less will be available for non-professional use. However, at the moment most anticoagulant rodenticides intended for both user categories have concentration limit of 0.005%. After the Annex VI of Regulation 1272/2008 will be revised relevant holders of authorization will be encouraged to contact their Competent Authority regrading their intentions wether they wish to keep existing concentration limit or not. If authorization holders wish to add concentration limit of 0.003% or less to make this product available for general use, they would have to apply for major change trough R4BP. In situation when authorisation holders wish to keep concentration limit of 0.005% and remove any uses by the general public, they would have to apply for a major change through R4BP. 


Biocidal products database has been updated

In order to provide public with more accurate information on biocidal products authorization in Republic of Lithuania, Vilnius Public Health Centre‘s Biocidal products database has been updated. The renewed database will give an opportunity to search for information regarding authorization not only issued by Vilnius Public Health Centre, but also by the State Food and Veterinary Service (SFVS). Updated database now is more functional and user-friendly when it comes to specific product search or selection for particular product for preview. Additionally, users might also find a brief but comprehensive user guide by pressing a „user guide“ link on the top right corner in the website. This user guide will help to navigate not only in the search but also in the preview windows. The updated database also provides users with possibilities to export their list of found biocidal products to the MS Excel format or to print it out, to search products by types or even to download a publicly available authorization certificate. It is expected that the updated Biocidal products database will facilitate work for the authorities, that are responsible for a control of biocidal products‘ use and will also provide detailed information to both professional and non-professional users regarding products available on Lithuania‘s market.
Biocidal products database has been updated under the European Union funded project "Biocidal products management system‘s improvement " (Project code VP1-4.3-VRM-02-V-05-007).

  

Important information concerning compliance with requirements of Article 95.2


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 ():
http://echa.europa.eu/web/guest/information-on-chemicals/active-substance-suppliers


Part 2 of mentioned Article 95 from 1st September 2015 bans making available on the market biocidal products when requirements of this article are not fulfilled. To implement this provision Vilnius Public Health Centre is checking files of authorised biocidal products; in case of non-conformity from 1st September 2015 will cancel biocidal product authorisation certificates in relevant cases.


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. Just to remind – any change of biocidal product active substance supplier must be notified to Vilnius Public Health Centre before change takes place.

 

15th July 2015 update. Persons placing biocidal products on the market may prove compliance with requirements of Article 95.2 also by providing confirmation of supply form.


Disinfection of ventilation channels – important

Ventilation channels and/or trash tubes in the flats may be disinfected using product-type 2 biocidal products.
Information from construction companies indicates that there is a need for such a biocidal products, but there are no products authorised for mentioned purpose in Lithuania.

Vilnius Public Health Centre invites interested persons to apply for authorisation of new biocidal products or for modification of an existing authorisations to include use for disinfection of ventilation channels and/or trash tubes in the flats.
 

Paskutinė atnaujinimo data: 2016-10-26