BIOCIDAL PRODUCT

Kondrat and Partners
legal aid in the market introduction of protection measures against Covid – 19 – biuro@kondrat.pl

Disinfectant containing ethanol – biocidal product

 

Legal requirements
  • Act of 9 October 2015 on biocidal products
  • Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012 on the making available on the market and use of biocidal products
What should I do?

It all depends on what the operator wants to manufacture, use or supply – the active substance, the biocidal product or the device treated with biocidal products

Analyse your dossiers regarding the legal status of the active substance and decide on further registration steps on this basis

Market access is based on a two-step
  • The active substance to be used in a biocidal product or treated with the product must be approved (positively evaluated for efficacy and safety) in the relevant product type at EU level
  • Before a biocidal product can be made available on the market (e.g. before it is sold) or used, it must be authorised at national or Union level
  • The competent authority for issuing a national authorisation to make the biocidal product available on the market shall be the President of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
  • Biocidal product that can be legally traded in Poland is included in the List of Biocidal Products

 

 

 

Obtaining a national marketing authorisation – dossier to be assessed
  • Application for a marketing authorisation
  • The content of the labelling of the packaging of the biocidal product in Polish, containing only the elements of the label in accordance with the requirements of Article 10(1) of Directive 91/414/EEC, shall be as set out in the Official Journal of the European Union. 33 of the Biocidal Products Act, including, but not limited to, the identity of all active substances and their concentrations given in metric units, the scope of use of the biocidal product, the words "read the accompanying information leaflet before use" if it is attached to a biocidal product
  • Reports of studies confirming the effectiveness of the biocidal product prepared in Polish or English
  • Biocidal product safety data sheet (if applicable)
  • Product identity statement (if applicable)
  • Authorization to use data (if applicable)
  • Information on the name of the active substance supplier or biocidal product supplier
  • Document confirming the legal status of the MAH
The marketing licence shall be issued within 6 months of receipt of the complete application for that licence

 

Obtaining an emergency permit for the COVID-19 pandemic

The possibility of benefiting from the derogation from the registration requirements provided for in Article 10(1) of Regulation (EC) No 1254/1999 shall be granted only Whereas article 55 (2) of the Treaty provides that the community may 1 of Regulation No 528/2012 on biocidal products[1]

What should I do to be able to benefit from a derogation from the normal registration requirements?
  • Apply to the President of the URPL for a derogation from the registration requirements in accordance with Article 10. Whereas article 55 (2) of the Treaty provides that the community may Regulation No 528/2012
  • The procedure is accelerated
  • The permit is issued for up to 180 days
  • The application shall be accompanied by the contents of the labelling of the packaging containing only the elements of the marking in accordance with the requirements of Article 10(1) of Directive 91/414/EEC. 33 of the Biocidal Products Act, The Design of Packaging or Efficacy Studies or the justification for their absence,
  • The Application Form is available here:

http://www.urpl.gov.pl/pl/komunikat-prezesa-z-dnia-13-marca-2020-r-w-sprawie-udzielania-odst%C4%99pstwa-od-requirement%C3%B3w-registration

The biocidal product already has marketing authorisations – what's next?

If the biocidal product has obtained a marketing authorisation and has already been made available in Polka, you must be aware that its further distribution may also entail the fulfilment by the distributor of additional obligations: i.e. making the Biocidal Product Safety Data Sheet available to customers or, for example, the obligation to provide information to downstream participants on the active substance

Export rules
  • No later than 36 hours before the intention to export or dispose of products for disinfection outside the territory of Polish, the governor responsible for the trader's registered office or place of residence must be informed therewith a list and quantity of products,
  • the Governor may submit an application to the Prime Minister to prohibit the export or disposal of these products outside the territory of Polish.
VAT rate

As a general rule, biocidal products and medical devices are taxed at a RATE of 23% or 8% of VAT. The amount of the rate depends on the assignment of the product to the correct final grouping of the PKWiU.

 

 

[1] Communication from the President of the URPL Communication of the President of 13 March 2020 on granting a derogation from the registration requirements provided for in Article 104(2) of the Treaty establishing the European Community Whereas article 55 (2) of the Treaty provides that the community may Article 1 of Regulation No 528/2012 on biocidal products in relation to a pandemic caused by SARS-Cov-2 coronavirus

 

 

Holler Box