How to register disinfectants in Ukraine in 2023?
Not so long ago, Ukraine re-introduced the disinfectants registration procedure. We are quite often contacted by people who want to get a detailed consultation on this issue.
Today we will elaborate on the authority responsible for the registration of disinfectants and the peculiarities of the registration procedure.
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What was the registration procedure before that?
In 2017, when the Sanitary and Epidemiological Service was abolished, some of its functions were transferred to the State Service of Ukraine for Food Safety and Consumer Protection and the Ministry of Health of Ukraine. The latter committed itself to develop a regulatory framework, namely, the procedure for clinical trials and verification of documents necessary for the registration of disinfectants.
In addition, the Resolution on the registration procedure adopted by the Cabinet of Ministers of Ukraine provided for two possible options for registration of disinfectants:
- On the basis of the positive conclusions of the State Service of Ukraine for Food Safety and Consumer Protection issued prior to the entry into force of the Resolution mentioned above.
- On the basis of clinical trials, developed instructions, labels, disposal method and other documents.
Accordingly, those who managed to get the conclusion of the Sanitary and Epidemiological Service (SES conclusion) before the Resolution came into force, were later able to register their disinfectant with the Ministry of Health (MOH) and conduct their activities absolutely legally for another 5 years.
Of course, there were also those who did not manage to do this. Since then, there was only one possible procedure of legalization: to obtain the conclusion of the Sanitary and Epidemiological Service (State Service of Ukraine for Food Safety and Consumer Protection) after the development of the disinfectant and to securely carry on their activity.
At the very least, you could collect a package of documents and submit it to the Ministry of Health to make assurance of proper legalization of your products double sure. However, this procedure was long and usually did not give any results.
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How to register a disinfectant today?
Recently, some amendments have been introduced to the Resolution of the Cabinet of Ministers of Ukraine on renewal of the registration procedure based on the conclusions of the State Service of Ukraine for Food Safety and Consumer Protection issued unti the MOH develops a regulatory legal act that would regulate the procedure of clinical trials and document evaluation.
Today, the registration procedure is as follows:
- The first step is to develop your own disinfectant, preferably using, for example, a specific formula approved by the World Health Organization (WHO).
- Next, you need to find a specialist who will help you develop the correct specifications.
- Get a positive SES conclusion on the specifications. In fact, this conclusion shall confirm the safety of the formula and the components of the disinfectant.
- The next step is to obtain another SES conclusion on the disinfectant. This conclusion shall confirm the safety of your disinfectant in general, as well as the fact that the combination of components used are not dangerous for human use.
- The last step will be the disinfectant registration with the MOH. Though this procedure was developed by the Cabinet of Ministers many years ago, it still has many inaccuracies, pitfalls and other surprises in practice.
If you want to register your disinfectant easily and without problems - it is better not to risk, and entrust a qualified lawyer with the entire registration procedure from beginning to end.
It’s worth remembering that some disinfectants, according to the level of their influence on human health, can be equated to drugs, which means that late or improper registration may lead to certain problems.
If you have any questions regarding the registration of disinfectants in Ukraine or you want to get assistance with such registration, don’t hesitate to call us.