| Summary |
The draft Law aims to regulate legal relations related to the approval of active substances of biocidal products, state registration, production, market placement, circulation and the safe use of biocidal products and processed products for human and animal health, and the environment. It aims also to define the rights and obligations of enterprises, institutions, organisations and individuals, along with the relevant powers. The draft Law proposes the designation of an authorized body - a state enterprise (institution or organization) - which, empowered by the central executive authority responsible for the formation and implementation of state healthcare policy, will be tasked with evaluating materials for the approval, renewal, or revision of active substances. The body will also prepare expert opinions with proposals for approval or refusal of approval, renewal, or revision of active substances, as well as expert opinions on the possibility of state registration of biocidal products and processed products. Services for evaluation of materials for approval, renewal or revision, state registration, state registration under a simplified procedure or refusal of registration of active substances shall be provided by the authorised body for a fee, in accordance with the agreement between the applicant and the authorised body. The procedure for setting the fee for services provided by the authorized body in evaluating applications for the renewal of approval of active substances shall be approved by the central executive authority responsible for the formation and implementation of state healthcare policy. The procedure for authorizing the body, the criteria that the authorized body (state enterprise, institution, or organization) must meet, the term of authorization, as well as the procedure revoking such authorization, will be approved by the Cabinet of Ministers of Ukraine. The draft Law stipulates that services related to the approval of active substances and state registration of biocidal products will be provided on a fee basis. The fee will be calculated based on the minimum living wage for working-age individuals (or the minimum wage), established on the date the service is paid. The draft Law also provides for the establishment of State Register of Biocidal Products, which will begin operating on 1 January 2029, and the transformation (through modernization) of State Register of Disinfectants into State Register of Biocidal Products. The draft Law is developed to implement Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012 concerning the making available on the market and use of biocidal products.
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