Registration of biocidal products through the so-called fast track (registration with derogations) or national registration
Legal sale of any type of biocidal product requires prior registration (marketing authorisation). The authorisation number assigned by URPL for the marketing of a particular biocidal product must obligatorily appear on the product packaging. This marking is strictly enforced by market supervisory authorities.
.Biocidal products can be registered under the national procedure (the most common form of registration), the European procedure (for making products available on other EU markets) and the so-called procedure with derogations (also known as the accelerated or simplified procedure).
Registration of biocidal products under the procedure with derogations
Now, in connection with the pandemic, the so-called simplified procedure (also called procedure with derogations) is in force. This registration pathway is valid from 13 March 2020 until further notice.
The Office for Registration of Medicinal Products, Medical Devices and Biocidal Products issues an authorisation to trade in biocides for a period not exceeding 180 days. This is an authorisation for disposal or use on the market of a biocidal product that does not meet the requirements of Regulation (EU) 528/2012 of the European Parliament and of the Council of 22 May 2012. Products placed on the market using the derogation procedure shall be subject to restricted and controlled use, all under the supervision of the competent authority.
The derogation procedure was introduced as a result of the pandemic, and the simplified URPL product registration process is intended to make the needed disinfectants available on the market to limit the development of the pandemic.
Registration of biocidal products in national procedure
Every registered biocidal product must meet the definition of a biocidal product as well as the requirements of REGULATION (EU) No 528/2012 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 22 May 2012 concerning biocidal products. The national procedure for the registration of biocidal products applies to products which contain existing active substances in their composition (evaluated) or which are under evaluation under COMMISSION DELEGATED REGULATION (EU) No 1062/2014 of 4 August 2014, of which at least one active substance has not yet been approved in the relevant product-type.
Laboratory Skin Lab International handles the registration of biocidal products in all available procedures. What is more, we draw up relevant documents, conduct research confirming the efficacy of a given biocidal product, as well as develop the content of leaflets/labels, which are later evaluated by URPL. We evaluate available documents from the substantive point of view and classify biocidal products into appropriate product classes. The laboratory Skin Lab International also provides services development of SDS (MSDS) for biocidal products (hazardous products), which are the basic document provided in the so-called supply chain.
Our extensive experience in registration allows us to quickly complete the relevant documentation, so that our customers receive the relevant marketing authorisations within a short period of time.
For those who have no idea what an effective biocidal, disinfectant or antibacterial product would look like, we offer professional assistance and a comprehensive service: from developing an effective product formulation to URPL registration. What is more, we can also manufacture a given product (contract manufacturing service).
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