Registration of biocidal products

We offer the service of registering 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 your product through us, you save time and money.

National registration of biocidal products

National procedure registration applies to products which > contain existing active substances assessed or under evaluation under Regulation 1062 / 2014 , of which at least one active substance has not yet been approved for a given product-type

A license 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 Regulation No. 528/2012 ;

2. the biocidal product contains existing active substances under evaluation or under evaluation under Regulation 1062/2014 but which are not have been approved for this product group;

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 comply with the requirements of Art. 95 of Regulation 528/2012.

The rotation permission specifies:

1. the name of the biocidal product;

2. number of the marketing authorization, issue date and expiry date;

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

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

5. the chemical name of the active substance or substances, or some other identifying name for the active substance and, if available, the CAS number, the determination of its content in the biocidal product in metric units;

6. product group;

7. formulation and intended use of the biocidal product;

8. user type information;

9. type of packaging;

10. shelf life of the biocidal product;

11. Polish biocidal product labeling

the name of the biocidal product;

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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 applies in the EU from 1 September 2013.

European procedures are for biocidal products where all active substances have been:

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

2. are included in Annex I to Regulation 528/2012, i.e. they are active substances presenting a low risk to human health and for the environment

The following registration procedures are possible for products containing approved active substances:

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

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

& lt; li & gt; mutual parallel recognition (MRP) of an authorization issued in another EU country – procedure leading to the issuance of a national authorization valid in Poland

• procedure leading to the parallel trade permit valid in Poland

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

For products containing active substances listed in Annex I to Regulation No 528/2012, registration takes place:

– following a simplified procedure leading to an authorization that may be valid for any EU country after prior notification of this authorization in that country.

To register biocidal products, please contact our Customer Service Center at 22 379 25 20 or biuro @ ekolabos .pl

Research on Biocidal Products