REGISTRATION OF DISINFECTANTS IN THE EAEU

STATE REGISTRATION OF DISINFECTANTS IN THE EAEU

Gaukhar Bilimbayeva, CEO of Registrarius Pharm Expert
Planning to launch a disinfectant on the market of the EAEU countries?
You’ve come to the right place. Registrarius Pharm Expert will guide your product through the entire regulatory pathway –
from dossier preparation to obtaining a State Registration Certificate valid in the territory of all EAEU Member States. No drawn-out timelines, refusals, or “last-minute” rework

With over 20 years of experience, we have completed more than 2,000 successful registrations of medicines, medical devices, food supplements, cosmetics, and food products in the territory of the Eurasian Economic Union.

Free initial consultation and cost estimate – we will answer all your questions and calculate the project budget through any communication channel convenient for you until the State Registration Certificate is obtained. No drawn-out timelines, refusals, or “last-minute” rework
Gaukhar Bilimbayeva, CEO of Registrarius Pharm Expert LLP, PharmD, MBA
We provide
registration
and pharmacovigilance services in the CIS countries, the EAEU, and Mongolia
We provide registration and pharmacovigilance services in the CIS countries, the EAEU, and Mongolia[…]
Kazakhstan
Kazakhstan
Türkiye
Türkiye
Uzbekistan
Uzbekistan
Tajikistan
Tajikistan
Georgia
Georgia
Azerbaijan
Azerbaijan
Russia
Russia
Mongolia
Mongolia
Belarus
Belarus
Turkmenistan
Turkmenistan
Moldova
Moldova
Kyrgyzstan
Kyrgyzstan
Armenia
Armenia
Ukraine
Ukraine
Upon receipt of your request, we will prepare a personalized commercial proposal with a detailed calculation of the full budget for the state registration of your product
in the Eurasian Economic Union. No hidden fees – you see the final price before the contract is signed.
PARTNERSHIP MODEL WITH REGISTRARIUS PHARM EXPERT
Commercial proposal
[01]
Bilimbayev Dauren,
Founder of Registrarius Pharm Expert
We sign an official contract with clearly defined timelines, obligations of the parties, and payment procedure. Payment is made in accordance with the terms of the agreement – flexibly
and conveniently for your accounting department.
Contract and payment
[02]
Registrarius Pharm Expert manages the project from kick-off to handover to the Client in full compliance with the contract terms. You receive regular progress reports on the registration, prompt feedback, and support at every stage
of interaction with the Authority.
Project execution
[03]
FROM 1 TO 12 MONTHS
Preparation of the dossier and local documents
UP TO 1 WEEK
Submission of the dossier and samples for state registration
UP TO 90 CALENDAR DAYS
Studies, examination and registration
Planning to register a disinfectant and launch it on the market of the Eurasian Economic Union countries? We have prepared for you a clear breakdown of all stages of state registration.

Our experience in the registration of disinfectants is backed by proven procedures and realistic timelines. Only working solutions, no inflated promises.
STATE REGISTRATION PROCESS FOR DISINFECTANTS
1.1
RECEIPT OF THE DOSSIER AND SAMPLES FROM THE MANUFACTURER
At this sub-stage, the basis for the state registration of the product is formed: the product dossier, samples for sanitary and hygienic studies, and the manufacturer's supporting documents are collected in accordance with the Uniform Sanitary and Epidemiological Requirements of the EAEU.

Timelines depend directly on how quickly the manufacturer provides the complete package of documents and samples, including the time required for customs clearance.

1.2
DEVELOPMENT OF LOCAL DOCUMENTS
In parallel, our team prepares a package of documents adapted to the requirements of the Authority:

  • Development of packaging mock-ups and instructions for use
  • Translation and notarization of the dossier
  • Preparation of the application for state registration

The timeline can be shortened if the manufacturer provides source materials in advance.

Stage #I
Each of the above stages has its own processes, timelines, nuances and risks, which we will help you successfully overcome with maximum benefit for you!!! Each of the above stages has its own processes, timelines, nuances and risks, which we will help you successfully overcome with maximum benefit for you!!! Each of the above stages has its own processes, timelines, nuances and risks, which we will help you successfully overcome with maximum benefit for you!!!
1-12 months
up to 30 days
Preparation of the dossier and local documents
Duration – from 1 to 12 months
Stage #II
Submission of the dossier and samples for state registration
Duration – up to 1 week
3.1
ISSUANCE OF THE CERTIFICATE OF STATE REGISTRATION
The final stage – issuance of the State Registration Certificate with assignment of a registration number. The data are entered in the unified EAEU register, which allows the products to be imported and sold in all Member States of the Union without repeating the procedure.
Stage #III
Studies, examination and registration
Duration – up to 90 calendar days
Obtaining approval from the Authority Duration — up to 10 working days
The foundation of the registration procedure. The completeness and correctness of the dossier at this stage determine how smoothly the studies and the examination will proceed. We know which documents, materials and samples are required, and we help the manufacturer assemble the package without errors or rework.
Once the dossier is fully assembled, the documents and samples of the product are officially submitted to the Authority, and the studies and examination procedure begins.
The most critical stage. Accredited laboratories carry out sanitary and hygienic studies of the product, while the Authority assesses its composition, labeling and packaging for compliance with EAEU requirements. Our specialists promptly address all queries to minimize registration timelines.
Common registration risks
and ways to overcome them
Non-compliance of the qualitative composition of the product with EAEU requirements
Preliminary review of the composition and formulation before the official submission of documents, to identify all non-conformities in advance.
Insufficient evidence for the claimed spectrum of antimicrobial activity
Verification of test reports and claimed application regimens for compliance with the requirements before submission of documents.
Late provision of samples and responses to queries by the manufacturer
Informing the manufacturer about the required quantity of samples and possible queries at the dossier preparation stage, and monitoring of delivery timelines, taking customs clearance into account.
Integrity and reputation are the foundation of our business.
We work so that, after the project is completed, you will want to recommend us to colleagues and partners. Every State Registration Certificate, every completed stage, is a contribution to the Company name we build painstakingly
and meticulously, year after year.
The cost of a mistake is months of lost time and a derailed product launch.
Deception, failure to deliver, or shifting responsibility are absolutely unacceptable to us. We take on a project only when we are confident that we will see it through to a successful outcome in the shortest possible timeframe.
A RELIABLE PARTNER IN DISINFECTANT REGISTRATION
Our guarantee
Registrarius Pharm Expert is built upon the professional expertise of one of its founders and the CEO of the company – Gaukhar Bilimbayeva – and the experience of every highly qualified specialist on our team.
The combined industry tenure of our employees exceeds 120 years of work in the pharmaceutical sector.
Over these years, we have progressed from registering straightforward generics to complex cases involving biological products, medical devices and non-standard manufacturing sites. This experience is your insurance against delays, refusals and rework
Company experience
successful GMP inspections by the Authorities of the CIS
more than 2,000 successful regulatory approvals, including medicines, medical devices, food supplements, cosmetics, and food products; we have organized and supported inspections and audits:
More than 30
successful internal audits with a positive GXP, GRP and GVP conclusion
More than 50
successful quality control inspections
More than 10
Our track record
Outsourcing
Focus on your business, while we take care of registration and pharmacovigilance!
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Proud of our team
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Gaukhar Bilimbayeva
Gulzhan Akhmetova
Anna Polivoda
Dauren Bilimbayev
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Maxim Sevostyanov
Bulegenova Zhadyra
Jenis Kamila
Asel Seidakhmetova
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We have over 50 international diplomas and certificates confirming our high qualifications and standards:
Training certificate
Training certificate
Training certificate
Training certificate
Training certificate
Training certificate
Training certificate
Training certificate
Training certificate
Training certificate
Training certificate
Training certificate
Training certificate
Training certificate
Training certificate
Training certificate
Training certificate
Training certificate
Training certificate
Training certificate
Training certificate
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dr.theiss naturwaren
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gsk
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Client testimonials
Client testimonials

Frequently asked questions about the registration of disinfectants in the EAEU

How long does it take to register a disinfectant in the EAEU?

Preparation of the dossier and local documents takes from 1 to 12 months, submission of the dossier and samples up to 1 week, and studies, examination and registration up to 90 calendar days.

What document is issued upon registration of a disinfectant, and where is it valid?

A State Registration Certificate with an assigned registration number is issued, valid in the territory of all EAEU Member States. The data are entered in the unified EAEU register, which allows the products to be sold in all countries of the Union without repeating the procedure.

How does the examination of a disinfectant in the EAEU work?

Accredited laboratories carry out sanitary and hygienic studies of the product, while the Authority assesses its composition, labeling and packaging for compliance with EAEU requirements.

Which documents and samples are needed to register a disinfectant?

The product dossier, samples for sanitary and hygienic studies and the manufacturer's supporting documents are collected in accordance with the Uniform Sanitary and Epidemiological Requirements of the EAEU. Packaging mock-ups and instructions for use are also developed, and the dossier is translated and notarized.

Which risks most often arise in the registration of disinfectants?

Common risks are non-compliance of the qualitative composition of the product with EAEU requirements and insufficient evidence for the claimed spectrum of antimicrobial activity. Therefore, the composition, test reports and application regimens are checked before submission.

REGISTRARIUS PHARM EXPERT office in Uzbekistan
REGISTRARIUS PHARM EXPERT office in Kazakhstan
Tashkent, 100000,
2 Quruvchi Massiv
Sales hotline: +7 (700) 178-67-67
Mail: info@registrarius.org
Republic of Kazakhstan, Almaty 050000
Miras microdistrict, Tan Nury residential complex, 128, apartment 19
Sales hotline: +7 (700) 178-67-67
Mail: info@registrarius.org
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Outsourcing with Registrarius Pharm Expert is simple and fast:
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Guaranteed deadlines
Planning negotiations.
Contract signing
Handover. Project launch
Monthly reports.
Online tracking
of product statuses.
Participation in reporting meetings
Cost savings
More time for business
Lower taxes
Freeing up a staff position
Qualified managers
Focus on your business, while we take care of registration and pharmacovigilance!
Outsourcing
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