New rules for production and registration of disinfectants under quarantine conditions

Due to the spread of coronavirus disease and the introduction of quarantine in Ukraine, there is much hype around disinfectants: even in online stores antiseptics are scarce goods.

Taking into account the latest legislative initiatives, production and/or sale of disinfectants is an extremely promising and potentially successful project.

Today, we will talk about changes in the disinfectants registration procedure and ways of undergoing such registration.

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Amendments to the disinfectant registration procedure

It’s worth noting that antiseptics may have hazardous properties, and some of them require specialized use. In order to protect the population and the environment from harmful factors, the state has established several mandatory procedures for official recognition of the disinfectant by the state. We described them in our previous publication.

It goes without saying that a simple antiseptic today plays an important role in fighting against the spread of infectious diseases. That’s why, on March 30, 2020, our government introduced temporary rules, according to which the production and circulation of disinfectants for the period of coronavirus is allowed without their state registration, if they are not dangerous for life and health.

What does this mean for the manufacturers of disinfectants? It is not clear from the text of the law whether regulatory authorities will require specialized confirmation of product safety. Will it be necessary to obtain the certificate of the Sanitary and Epidemiological Service (SES Certificate) on products?

In this regard, the Association of Disinfectant Manufacturers expressed the position that it is necessary to at least approve the requirement for obtaining of the SES Certificate on the products.

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However, a simplified interpretation is also possible: in case the products do not contain internationally recognized hazardous substances (according to the UN GHS and EU Regulation No. 1272 / 2008), they can be safely used.

The only question that arises is, Who and when will verify this and how will the inspection authority behave in this situation?

Why do lawyers still advise to register disinfectants?

Each manufacturer or importer should do its best to protect themselves from possible objections of government authorities. In addition, it should be understood that quarantine measures will not last forever. It is likely that the transition period may not come, and the unsold products will at some point be confiscated as illegally manufactured.

The Certificate of disinfectant state registration will legalize any commercial turnover within five years.

And it’s better to conduct the registration today, rather than after the end of quarantine, because the abovementioned amendments have actually unblocked the registration procedure, leveling the defects of the previous version of the Resolution.

Some statistics: since the entry into force of the amendments, 39 new disinfectants have been registered for less than a week, while during the year, before the amendments, there were only 9 registered disinfectants, and for the whole of 2019 - 222 disinfectants (these were mainly goods that have been on the market for decades and their registration was just renewed). This means that with the qualitative preparation of documents you can complete the procedure much faster.

Today, to obtain a registration certificate, it is necessary to submit the following documents to the Ministry of Health:

• An application of optional form containing information about the manufacturer, a description of the product and the application method, other general information;
• A certified copy of the SES Certificate on the product

Within 30 days the MOH is obliged to enter the disinfectants into the Register, which will mean its state registration and allow the free circulation of disinfectants within Ukraine.

Our company has successful experience of full A to Z support of disinfectants turnover, both for manufacturers of products and for importers.

We offer:

• To develop specifications for the disinfectants production, to register them;
• To obtain the SES Certificate on specifications;
• To obtain the SES Certificate on the disinfectant;
• To register the disinfectant with the Ministry of Health.

If you need assistance to quickly and efficiently register disinfectants, don’t hesitate to call us.