AND DECLARATION OF CHILDREN'S PRODUCTS IN THE EAEU
CERTIFICATION AND DECLARATION OF CHILDREN'S PRODUCTS IN THE EAEU
Planning to launch children's products on the market of the EAEU countries?
You’ve come to the right place. Registrarius Pharm Expert will guide your products through the entire regulatory pathway – from determining the applicable form of conformity assessment to obtaining a certificate, declaration or 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 permit document is obtained.
No drawn-out timelines, refusals, or “last-minute” rework
You’ve come to the right place. Registrarius Pharm Expert will guide your products through the entire regulatory pathway – from determining the applicable form of conformity assessment to obtaining a certificate, declaration or 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 permit document is obtained.
No drawn-out timelines, refusals, or “last-minute” rework
Gaukhar Bilimbayeva,
CEO of LLP «Registrarius
Pharm Expert», PharmD, MBA
CEO of LLP «Registrarius
Pharm Expert», PharmD, MBA
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 products 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
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 children's products and launch them 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 children's products is backed by proven procedures and realistic timelines. Only working solutions, no inflated promises.
We have prepared for you a clear breakdown of all stages of state registration.
Our experience in the registration of children's products is backed by proven procedures and realistic timelines. Only working solutions, no inflated promises.
CONFORMITY ASSESSMENT PROCESS FOR CHILDREN'S PRODUCTS
1.1
RECEIPT OF THE DOSSIER, REFERENCE STANDARDS AND SAMPLES FROM THE MANUFACTURER
At this sub-stage, the basis for the state registration of the medicinal product in the EAEU is formed: the necessary materials are collected, the registration dossier is prepared, and reference standards
and samples are requested in accordance with the requirements of
EEC Council Decision No. 78.
Timelines depend directly on how quickly the manufacturer provides the complete package of documents and samples.
and samples are requested in accordance with the requirements of
EEC Council Decision No. 78.
Timelines depend directly on how quickly the manufacturer provides the complete package of documents and samples.
1.2
DEVELOPMENT OF LOCAL DOCUMENTS
In parallel, our team prepares a package of documents adapted to the requirements of the Eurasian Economic Union:
- Translation of documentation into the state languages of the Member States of the Union
- Adaptation of packaging mock-ups to EAEU labeling requirements
- Development and preparation of local documents according to the requirements of the country of application
- Preparation of the complete set of documents and the application for state registration
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 45 days
Preparation of the dossier and local documents
Duration – from 1 to 12 months
Duration – from 1 to 12 months
Stage #II
Stage #III
Electronic version – 10 working days. Paper version – up to 3 months.
The final stage — issuance of the EAEU marketing authorization confirming the safety of the medicinal product and the right to market it. The data are entered in the Unified Register of Registered Medicines of the Union, and the marketing authorization holder is able to expand its presence to the markets of other Member States of the Union under the recognition procedure.
The final stage — issuance of the EAEU marketing authorization confirming the safety of the medicinal product and the right to market it. The data are entered in the Unified Register of Registered Medicines of the Union, and the marketing authorization holder is able to expand its presence to the markets of other Member States of the Union under the recognition procedure.
ISSUANCE OF THE EAEU MARKETING AUTHORIZATION
Examination and registration procedure
Duration – 140 working days / 7 months
**excluding clock-stops (time for addressing deficiency letters). Including clock-stops at each stage — maximum of 410 working days
Duration – 140 working days / 7 months
**excluding clock-stops (time for addressing deficiency letters). Including clock-stops at each stage — maximum of 410 working days
Obtaining approval from the Authority Duration — up to 10 working days
The foundation of the procedure. TR CU 007/2011 provides for three forms of conformity assessment: state registration followed by declaration, declaration, and mandatory certification. The entire further path of the products depends on how correctly the form is determined and the dossier is compiled at this stage.
Once the dossier is fully assembled, the documents are officially submitted to the Authority, and the examination of the dossier and samples under the procedure established by EAEU rules begins.
The most critical stage. Experts of the Authority carry out a comprehensive review of the product dossier and samples in accordance with EAEU rules, while our specialists promptly address all queries and deficiencies to minimize clock-stops and avoid delays in obtaining the marketing authorization.
The timeline can be shortened if the manufacturer provides source materials in advance.
Common registration risks
and ways to overcome them
and ways to overcome them
Late provision of documents, reference standards and samples by the manufacturer
Informing the manufacturer of the full list of required materials at the start of the project and monitoring the timelines for their provision.
Non-compliance of analytical methods and quality standards with the requirements of the pharmacopoeias applied in the EAEU
Preliminary review of the product's regulatory documentation for compliance with EAEU requirements before the official submission.
Lengthy development and approval of packaging mock-ups
Advance preparation and adaptation of mock-ups in parallel with dossier compilation.
Delays due to queries from the Authority during the examination (clock-stop)
Preparation of a maximally complete dossier to preclude queries from the Authority, and prompt handling of deficiencies.
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 marketing authorization, 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 launch of the medicinal product on the markets of the EAEU countries.
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.
We work so that, after the project is completed, you will want to recommend us to colleagues and partners. Every marketing authorization, 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 launch of the medicinal product on the markets of the EAEU countries.
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 MEDICINES REGISTRATION IN THE EAEU
Our guarantee
Registrarius Pharm Expert is built upon the professional expertise of one of its founders and the CEO of the company – Gaukhar Bilimbayeva,
120 years of combined team experience, GMP inspections and audits
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
120 years of combined team experience, GMP inspections and audits
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
Maxim Sevostyanov
Director of Global Regulatory and Medical Translations
Education:
2015—2019 — Manash Kozybayev
North Kazakhstan University
gaukhar bilimbayeva
Chief Executive Officer (CEO), PharmD, MBA
Education:
1997—2002 — S. Asfendiyarov Kazakh National Medical University
2016—2018 — MBA, Swiss Business School, Zurich, Switzerland
dauren bilimbayev
Founder
Education:
2000—2004 — T. Ryskulov Kazakh Economic University
2003—2005 — S. Amanzholov East Kazakhstan State University
2016—2017 — NIMA International Marketing School, the Netherlands
Anna polivoda
Deputy CEO, Head
of Sales and Marketing
Education:
2018—2022 — Almaty Management University (AlmaU)
2022—2024 — Sh. Murtaza International University
gulzhan akhmetova
Head of Registration Department,
Quality Responsible Person
Education:
2005—2009 — Al-Farabi Kazakh National University
2013—2015 — K. I. Satpayev Kazakh National Technical University (KazNTU)
Bulegenova Zhadyra
Senior Registration Specialist
Education:
2008-2012 — Al-Farabi Kazakh National University (Bachelor's)
2012-2014 — S. Asfendiyarov Kazakh National Medical University (Master's)
Jenis Kamila
Registration Specialist
Education:
2016-2020 — S. Asfendiyarov Kazakh National Medical University
Asel Seidakhmetova
Senior Registration Specialist
Education:
2006-2010 — Kazakh National Agrarian University (KazNAU)
Client testimonials
Client testimonials
Frequently asked questions about the certification and declaration of children's products in the EAEU
Which forms of conformity assessment apply to children's products in the EAEU?
TR CU 007/2011 provides for three forms of conformity assessment: state registration followed by declaration, declaration, and mandatory certification. The entire further path of the products depends on choosing the right form.
What document can be obtained for children's products to sell them in the EAEU?
Depending on the applicable form of conformity assessment, this is a certificate, a declaration or a State Registration Certificate valid in the territory of all EAEU Member States.
How long does it take to prepare and submit documents for children's products?
Preparation of the dossier and local documents takes from 1 to 12 months, and submission of the dossier and samples for state registration up to 1 week. The timeline can be shortened if the manufacturer provides source materials in advance.
How much does the conformity assessment of children's products in the EAEU cost?
The cost is calculated individually: after your request, a personalized commercial proposal is prepared with a detailed calculation of the full budget, with no hidden fees. A free consultation and preliminary cost estimate are available.
REGISTRARIUS PHARM EXPERT office in Uzbekistan
REGISTRARIUS PHARM EXPERT office in Kazakhstan
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
Miras microdistrict, Tan Nury residential complex, 128, apartment 19
Sales hotline: +7 (700) 178-67-67
Mail: info@registrarius.org
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Handover. Project launch
Monthly reports.
Online tracking
of product statuses.
Participation in reporting meetings
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!
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