Procedure for registration of disinfectants (biocides) in Ukraine
Disinfectants (biocides) are subject to state registration before placing on the market of Ukraine. The Ministry of Health of Ukraine is the competent authority for product registration and maintenance of the state register of approved products.
The legislation of Ukraine significantly differs from European Union. The definition of “biocide” used in Directive 98/8/EC is much more comprehensive and includes some groups of products that in Ukraine do not fall under the definition of “disinfectant”.
Disinfectants include products for:
- disinfecting measures in residential, industrial, educational, sanitary and other premises, healthcare facilities,
- hand disinfection (antiseptics),
- disinfection of air, water (except for drinking water), industrial and domestic wastewater;
- scaring away and destruction of carriers of pathogens of infectious diseases, insects, rodents;
- sterilization cleaning, “cold” sterilization and quality control of sterilization of medical devices.
Prior to registration
We recommend a feasibility study before registration activities will start. Ukraine’s list of allowed active substances is not harmonized with EU requirements. Not all disinfectants can be registered in Ukraine, even if approved in the EU, Switzerland, USA, UK, or other countries.
Registration is only possible if:
- the active ingredients of the finished product are registered and listed in the register of hazardous factors, and
- the active ingredients are included in the hygiene regulations approved by the Orders of the Ministry of Health of Ukraine.
Failure to comply with any of the requirements may result in the refusal of registration by the Ministry of Health of Ukraine.
The Ministry of Health of Ukraine performs state registration of disinfectants and maintenance of the state electronic register of approved products.
The State Consumer Service of Ukraine accepts Applications for sanitary-epidemiological assessment, issues sanitary-epidemiological conclusions and performs state market supervision.
Assessment of documentation and testing of samples for sanitary-epidemiological examination is carried out by authorized expert organizations.
The procedure for registration of disinfectants is approved by the Decree of the Cabinet of Ministers of Ukraine No. 908 dated July 3, 2006. The legal act defines two routes for the registration:
- based on a positive conclusion of the sanitary-epidemiological assessment (expertise) – until the procedures for the assessment of specific activity, safety, quality (efficacy) and practical testing will come into force,
- or based on an assessment of protocols of assessment of specific activity, safety, quality (efficacy) and practical testing.
Currently, the assessment procedures of specific activity, safety, quality (efficacy) and practical testing are not approved; registration is carried out only based on the sanitary-epidemiological conclusion.
Steps of the registration procedure:
- A feasibility study (review of the composition and indications).
- Filling the initial set of administrative and technical documentation from the manufacturer.
- Translations and filling of national documentation in the Ukrainian language: Application, cover letters, labeling and instructions for use (leaflet).
- Submission of the Application to the State Consumer Service of Ukraine.
- Submission of the set of documents and samples to the authorized institute for examination and testing.
- Answers on the deficiencies, if any.
- Obtaining a positive conclusion of the sanitary-epidemiological assessment.
- Submission of Application and conclusion to the Ministry of Health of Ukraine.
- The Ministry of Health within 30 days makes a decision (order) on product registration.
The register of disinfectants is maintained by the Ministry of Health of Ukraine in electronic form.
Exceptions to registration
Law of Ukraine “On the Protection of the Population from Infectious Diseases” was amended due to the spread of COVID-19 with the statement that “production and use of disinfectants is allowed without a state registration in case if such disinfectant contains no active substances that are dangerous for human health”.
Since the active ingredients of disinfectants are classified as hazardous factors, de facto this exclusion does not work.
We are not aware of other exceptions or simplified registration procedures.
Maintenance of registration, variations and renewal
The State Register of Disinfectants contains:
- the name of the product,
- the name and address of the Applicant (holder),
- the name and address of the manufacturer,
- intended use (scope of application of the product),
- the registration date and order number,
- the expiry date.
There are no payments or other activities to maintain registration within the validity of the registration.
To make changes or to renew registration for the next period, it is necessary to apply for re-registration. Renewal of registration is carried out identically to the new registration.
We offer comprehensive consulting services on state registration of disinfectants (biocides) in Ukraine. We proactively and professionally organize the registration process in a short time.