We offer a service of registration of biocidal products at the Office for Registration of Medicines, Medical Devices and Biocidal Products. The offer includes registration in both the national and European procedures. We help in completing the documentation. We provide all necessary laboratory tests before implementation By registering the product through us, you save time and money.

Registration of biocidal products in the national procedure

Rejestracja w procedurze narodowej ma zastosowanie do produktów, które zawierają istniejące substancje czynne poddane ocenie lub będące w fazie oceny na mocy rozporządzenia nr 1062/2014, z których co najmniej jedna substancja czynna nie została jeszcze zatwierdzona dla danej grupy produktowej

A marketing authorization may be issued if the following conditions are met:

  1. the product meets the definition of a biocidal product in Art. 3 sec. 1 letter a of Regulation No 528/2012;

  2. the biocidal product contains existing active substances assessed or under evaluation under Regulation 1062/2014 but not approved for this product-type;

  3. the biocidal product is effective against the harmful organism;

  4. safety rules for the use of the biocidal product have been defined;

  5. the intended use of the product should be included in the categories and groups included in Annex V to Regulation No. 528/2012;

  6. and the supplier of the active substance (or biocidal product) should meet the requirements referred to in Art. 95 of Regulation No 528/2012.

The marketing authorization specifies:

  1. the name of the biocidal product;

  2. the number of the marketing authorization as well as the date of issue and its expiry date;

  3. name and surname and address or name (company) and address of the registered office of the responsible entity;

  4. name and surname and address or name (company name) and address of the registered office of the manufacturer of the biocidal product;

  5. the chemical name of the active substance or substances or another name allowing the identity of the active substance to be identified and, if the CAS number is available, its content in the biocidal product in metric units;

  6. product group;

  7. the formulation of the biocidal product and its intended use;

  8. information about the type of user;

  9. a kind of package;

  10. shelf life of the biocidal product;

  11. the content of the biocidal product packaging labeling in Polish

Registration of biocidal products under the European procedure

Registration of biocidal products according to the so-called European procedures are carried out in accordance with the rules described in detail in Regulation No. 528/2012, which apply in the EU from September 1, 2013.

The European procedures apply to biocidal products where all active substances have been:

  1. approved for a given product group (PT), i.e. passed the review program assessment, or

  2. are included in Annex I to Regulation No 528/2012, i.e. they are active substances with a low risk to human health and the environment

For products containing approved active substances, the following registration procedures are possible:

    1. the procedure leading to the issue of a national permit valid in Poland

<li>Mutual Sequential Recognition (MRS) of an authorization issued in another EU country – a procedure leading to the issuance of a national authorization valid in Poland
<li>mutual recognition in parallel (MRP) of an authorization issued in another EU country – a procedure leading to the issuance of a national authorization valid in Poland

  • a procedure leading to the issuance of a permit for parallel trade, valid in Poland

  • the procedure leading to the issuance of an EU authorization, valid in all EU countries

In the case of products containing active substances listed in Annex I to Regulation No 528/2012, the registration takes place:

– in accordance with the simplified procedure leading to the issuance of a permit that may be valid in any EU country after prior notification of this permit in a given country.

For the registration offer of biocidal products, please contact the Customer Service Office at +48 22 379 25 20 or office@ekolabos.com

Research on Biocidal Products