Comprehensive advice. Registration at the office
Biocidal products placed on the market in Poland require a marketing authorization that is positively registered with the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products (UPRLWMiPB).
Starting from 1st of September 2015, a biocidal product consisting of, containing or generating a suitable substance, cannot be made available on the EU market if the supplier of the substance or product is not listed on the basis of art. 95, concerning the type (s) of the product to which belongs the given product containing the active substance the review of which has not yet been completed.
Registration of biocidal products. Support of entrepreneurs in the registration process.
1. Verification and assessment of enclosed documentations;
2. Preparation and submission of documentation to URPLWMIPB;
3. Preparation of the safety data sheet of the biocidal product;
4. Support in the preparation of documentation for a change in the marketing authorization;
5. Monitoring the course of the product registration process;
6. Representing the entrepreneur before URPLWMIPB;
7. Preparation of the contents of the label, leaflets and packaging of the biocidal product in accordance with regulations;
8. Assistance in carrying out laboratory tests for a biocidal product (choice of methodology for efficacy testing);
9. Advice on law, biocidal products and documentation.