Biocidal Products

THETA Consulting has many years of experience in the registration of biocidal products. Our experts will guide you through the process of obtaining authorisation – starting with the selection of the most economically viable registration procedure, through assistance in the selection of active substances and tests necessary for the preparation of the registration dossier, comprehensive evaluation of data, preparation and submission of the dossier and conducting the registration procedure. Acting on behalf of our clients, our advisors also represent them before the relevant authorities, monitoring registration procedures until authorisation is granted.

All biocidal products (biocides) placed on the market or used in the territory of Poland are subject to registration and authorisation in the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products (Polish: URPLWMiPB).

They may be registered in transitional (so-called national) procedures or in European procedures. The type of registration procedure does not depend on the choice of the registrant but, inter alia, on the active substances contained in the product and its use. The most important step in registering a biocidal product is to agree on an appropriate registration strategy to optimise the time and costs.

Products containing at least one active substance, the evaluation of which (carried out under the review programme for active substances) has not yet been finalised, shall be registered under the transitional procedures.

As part of the registration under the national procedure we offer:

• determination of the status of active substances;
•  assessment of the dossier;
•  assistance in the choice of methodology for efficacy studies;
•  assistance with laboratory tests;
•  preparation of a complete dossier for registration with URPLWMiPB;
•  representation of the entity before URPLWMiPB;
•  preparation of the product label;
•  compilation of a material safety data sheet (MSDS);
•  monitoring of the product registration process;
• assistance in the preparation of documentation in scope of changes to the authorisation;
• support in case of inspections;
• ongoing consulting services and training;
• certified translations of documents.

Registration under the European procedure

As the work under the review programme progresses, the pool of approved active substances is consistently increasing. As a result, an increasing number of biocidal products are subject to registration in European procedures.

The requirements in the European procedure vary according to the biocidal product and the active substances in the product. The extent of the tests that need to be carried out depends, amongst other things, on the composition of the product including the active substances, substances of concern and the declared intended use of the product. This multitude of complex documents, test results, efficacy assessments, makes the European registration procedure extremely complicated, time and labour-consuming.

It is crucial to choose the right registration procedure, the scope of testing and the documentation to be submitted in order to obtain the authorisation, which also has a significant impact on the cost of registration.

As part of the European procedure registration, we offer:

• analysis of existing documentation;
• assistance in the choice of registration strategy;
• selection and conduct of tests;
• preparation of documents for registration with IUCLID;
• handling product registration;
• representation of the entity before URPLWMiPB;
• monitoring of the procedure until authorisation is granted;
• preparation of a summary of the product characteristics (SPC);
• registration of the product in the European Register of Biocidal Products;
• ongoing consulting services and training;
• support in case of inspections;
• translations of documents.

Get in touch with our experts! Thanks to our many years of experience, we are able to provide an individual solution for every requirement.