Apart from the basic requirements, such as correct classification, labelling and preparation of MSDS, imposed on the chemical products (including biocides), all the biocidal products (biocides) placed on the market within the territory of Poland are also subject to the registration requirement (marketing authorisation). The necessary condition enabling the sales of a product, is to obtain a relevant authorisation for marketing, through meeting some specific requirements, and registration in the Office for Registration of Medicinal Products Medical Devices and Biocidal Products (URPLWMiPB). Currently, biocidal products can be registered in accordance with so called national procedure (transitional one), and some of them in accordance with so called European procedure.
The core document governing the issue of placing biocidal products on the market is the Regulation of the European Parliament and of the Council (EU) of 22 May 2012 concerning the making available on the market and use of biocidal products.
Another legal act in force is the Act on biocidal products (Journal of Laws of 2007 No 39, item 252 with further amendments).
Although the requirements concerning the obligatory marketing authorisations are commonly known, the procedure itself is a real burden for the companies. Most of all, they face substantial issues related to preparation of a complete dossier compliant with the requirements of the Registration Office (URPLWMiPB).
Moreover, the whole procedure requires the time-consuming supervision, exchange of correspondence and, frequently, completing the documentation as well. All that, combined with the ambiguous interpretation of the law, results in the whole procedure being prolonged for months. Consequently, your company cannot place its product on the market, loses its market shares or comes into conflict with the controlling bodies. The authorisations are granted for a specific period of time. The crowning of the whole registration process, apart from issuing the authorisation itself, means also including the product in question by the URPLWMiPB on the list of products certified for marketing in Poland.
See the current list of authorised biocidal products>>>
THETA Doradztwo Techniczne performs the complete procedure of obtaining the marketing authorisations for the biocidal products, both, in the national procedure and in accordance with the new regulations, i.e., European procedure. We perform the overall evaluation of the available documentation, regarding its substantial correctness and usefulness for the registration process, as well as the completion of missing documents, including the laboratory test results, and we submit the complete dossier to the URPLWMiPB.
The scope of obligatory documentation concerning biocidal products is very wide and depends on the composition of the biocidal product itself, including active substances, potential hazardous impact of such product on humans or environment, as well as declared use of the product.
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Moreover, THETA tracks, on a current basis, all the changes to regulations and procedures, and that is why we are always able to offer the most up-to-date knowledge and professional, substantial support, enabling placement of biocidal products on the market, as well as effective coping with the requirements of the supervising bodies.
In compliance with Article 89 par. 2 of the biocidal regulation 528/2012, Member States can continue to apply their current system or practice of making a given biocidal product available in their territories, during so called transitional periods. It means, that for the products containing in their composition active substances existing in the review programme, national procedures continue to apply, in case the marketing authorisations are granted in accordance with Article 54 of currently applicable Act on Biocidal Products of 13 March 2002 (Journal of Laws No 175, item 1433 with further amendments).
The work programme conducted by the Commission, consisting in systematic evaluation of all the existing active substances, will be continued until 31.12.2024. It means, that the transitional period currently applicable until 14.05.2014 was extended till the end of the year 2024.
Scope of our offers includes (national procedure):
- Providing consulting services, on a current basis, in scope of selection of active substances, verification of active substances and defining their status in the review programme.
- Supporting the selection of the suitable methodology for the biocidal product’s efficacy tests, relevant for the specific product group.
- Preparation of application for approval of unapproved methodology for the efficacy tests.
- Preparation of the biocidal product’s label.
- Technical and substantial support in scope of conducting laboratory tests regarding the biocidal product’s efficacy.
- Substantial and formal evaluation of documents, and in particular analysis of the efficacy tests with regard to meeting all the requirements necessary to receive the authorisation to place the biocidal product on the Polish market.
- Completion, supplementation and submission of documentation to the URPLWMiPB.
- Acting on behalf of the authorisation holder before the URPLWMiPB.
- Monitoring of the course of biocidal product’s registration process.
- Responding to inquiries and reports following the inspections.
- Providing consulting services, on a current basis, in scope of placing biocidal products on the market.
- Professional, certified translations of the registration dossier from most of the European languages, inter alia from English, German, Italian, French, Czech, Russian and other.
Regulation of the European Parliament and of the Council (EU) No 528/2012 of 22 May 2012 concerning the making available on the market and use of biocidal products replaced the currently applicable Directive 98/8/EC concerning the making available on the market of biocidal products. Regulation 528/2012 ensures, that legal requirements are implemented at the same time and in a harmonised manner throughout the Union.
Applications for granting the marketing authorisation can be submitted at different times, depending on the product and its status; differently for the products already existing on the market (i.e., these, which are currently granted with the valid marketing authorisation), and in another way for the new products, which are going to be placed on the market for the first time. Also the date of approval of the last active substance contained in the given products is of a great importance.
Requirements in the European procedure, concerning the scope of biocidal product’s dossier differ depending on the biocidal product itself and on the active substances included in this product’s composition. However, they are always very broad, and cover, among others, results of the physical and chemical properties, toxicology, ecotoxicology and the efficacy studies for the product in question. The scope of the test depends on the composition of the biocidal product, taking into consideration the active substances, substances of concern, their transformation products and declared use of the product. This extreme multitude of sophisticated documents, test results, efficacy evaluations, makes the new registration procedure even more complicated plus time- and labour-consuming, for the companied obliged to go through it.
THETA Doradztwo Techniczne created the team of experts with long-term experience in the field of the biocidal product registration. Our experts are ready to support your selection of suitable tests necessary to prepare the complete registration dossier based on the new, harmonised procedures. We are ready to lend a helping hand to the companies being in possession of currently valid marketing authorisations and to those entities, who are placing new biocidal products on the market.
Scope of our offers includes (European procedure):
- Preparation of complete documentation, submission and supervision over the whole procedure until the required approval in the European procedure is granted.
- Consulting services in scope of implementation of European procedures concerning the approval for marketing of biocidal products.
- Support in scope of preparation of documents required for the full registration of biocidal products and MRP procedure (Mutual Recognition Procedure).
- Support in scope of selection of obligatory physical, chemical, toxicological, ecotoxicological tests, efficacy tests and analytical methods.
- Registration of biocidal products in the European biocidal products register, together with generation of the R4BP application form.
- Compilation of documentation in IUCLID.
- Support in scope of ordering suitable basic tests and additional tests regarding physical, chemical, toxicological, ecotoxicological properties.
- Professional, certified translations of the registration dossier from most of the European languages, inter alia from English, German, Italian, French, Czech, Russian and other.
