Changes in marketing authorization of disinfectants. What is updated in CMU draft resolution?

A public discussion of the Cabinet of Ministers of Ukraine (CMU) draft resolution "On approval of the Regulation on the state registration of disinfectants" (hereinafter referred to as the draft resolution) has been recently completed. By this document, the Health Ministry proposes to update the procedure for marketing authorization (state registration) of disinfecting agents (hereinafter referred to as disinfectants). The Health Ministry is currently drafting a report on the discussion.

It should be reminded that applicable resolution of the Cabinet of Ministers No. 908 "On approval of the Procedure for state registration (re-registration) of disinfectants" of July 3, 2006 stipulates a quite simple algorithm for marketing authorization of disinfectants. Thus, the marketing authorization (re-authorization) of disinfectants shall be conducted by the Health Ministry on the grounds of the submitted set of documents or the state sanitary and epidemiological expertise's conclusion on compliance with the sanitary rules. Upon review of the documents, the Health Ministry shall make a decision on approval or refusal of marketing authorization (re-authorization).

For the purpose to implement the first part of Article 48 of the Law of Ukraine "On the public health system," the Health Ministry is proposed to determine a new algorithm of marketing authorization of disinfectants, to be as follows:

1. The applicant for marketing authorization of the agent shall submit to the Committee a set of documents, in particular, an application, a marketing authorization file, results of the agent assessment, samples of the label and instructions for disinfectant use, and others.

2. The registration materials adopted by the Committee shall be submitted to the experts of the relevant Commission for marketing authorization and re-authorization of disinfectants established within the Committee. The Committee is also able to require the applicant to provide appropriate additional information on the disinfectant, if necessary to assess its safety and efficacy.

3. The Committee shall develop an expert conclusion and sends it to the applicant or an authorized person and the Health Ministry. The expert conclusion may certify compliance (positive) or non-compliance (negative) with the sanitary rules. A positive conclusion provides a recommendation for marketing authorization of the disinfectant. A negative conclusion may be based on non-compliance of the disinfectant or documents with the established requirements or insufficient evidence of efficacy or safety of the disinfectant, etc.

4. After receipt of the expert conclusion, the Health Ministry shall make a decision on approval or refusal of marketing authorization of disinfectant and, accordingly, shall enter or not enter information on the disinfectant specified in the decision on its marketing authorization into the State Register of disinfectants.

Thus, the draft resolution proposes to change the procedure for marketing authorization of the disinfectant, while expanding and specifying the requirements for the composition and content of the relevant documentation.

It is worth noting that the team of Legal Alliance Law Firm stands ready to accompany the procedure for registering a disinfectant in Ukraine at every stage, assist in preparing the necessary documents and legal support. Please contact Counsel of Legal Alliance Lidia Sanzharovska at: sanzharovska@l-a.com.ua.