OF MEDICINES IN
KAZAKHSTAN
KAZAKHSTAN
NATIONAL
REGISTRATION OF MEDICINES IN KAZAKHSTAN
Planning to launch a medicinal product on the market of the Republic of Kazakhstan?
You’ve come to the right place. Registrarius Pharm Expert will guide your product through the entire regulatory pathway – from registration dossier preparation to obtaining the marketing authorization. We structure the process to minimize deficiencies, rework and delays.
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.
Free initial consultation and cost estimate – we will answer all your questions and calculate the project budget through any communication channel convenient for you
You’ve come to the right place. Registrarius Pharm Expert will guide your product through the entire regulatory pathway – from registration dossier preparation to obtaining the marketing authorization. We structure the process to minimize deficiencies, rework and delays.
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.
Free initial consultation and cost estimate – we will answer all your questions and calculate the project budget through any communication channel convenient for you
Gaukhar Bilimbayeva, CEO of Registrarius Pharm Expert LLP, PharmD, MBA
Upon receipt of your request, we will prepare a personalized commercial proposal with a detailed calculation of the full budget for the national registration of your product in the Republic of Kazakhstan. 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 registration dossier, reference standards and samples
UP TO 10 WORKING DAYS
Submission of the dossier and materials for registration
140 TO 275 WORKING DAYS
Examination and registration procedure
Planning to launch a medicinal product on the pharmaceutical market of the Republic of Kazakhstan? We have prepared for you a clear breakdown of all stages of national registration.
Our experience in the national registration of medicines is backed by proven procedures and realistic timelines. Only working solutions, no inflated promises.
Our experience in the national registration of medicines is backed by proven procedures and realistic timelines. Only working solutions, no inflated promises.
NATIONAL REGISTRATION PROCESS FOR MEDICINES
1.1
2.1
RECEIPT OF THE DOSSIER, REFERENCE STANDARDS AND SAMPLES FROM THE MANUFACTURER
EXAMINATION AND REGISTRATION PROCEDURE
At this sub-stage, the basis for the national registration of the product is formed: the registration dossier is collected in CTD format, and reference standards and samples are requested
Timelines depend directly on how quickly the manufacturer provides the complete package of documents, reference standards and samples; we, in turn, shorten them by giving the manufacturing site precise and clear requirements from the outset.
Timelines depend directly on how quickly the manufacturer provides the complete package of documents, reference standards and samples; we, in turn, shorten them by giving the manufacturing site precise and clear requirements from the outset.
The most critical stage. Experts of the Authority carry out a comprehensive review of the product dossier and samples The examination takes place in several stages: initial examination (verification of dossier completeness), specialized examination (assessment of quality, efficacy and safety), laboratory testing of samples, and preparation of the conclusion on safety, efficacy and quality. At each stage, the experts may issue deficiency letters, and the speed and quality of the responses determine whether the examination fits within the statutory 140 working days or stretches to more than a year. Our specialists promptly address all queries and deficiencies to minimize clock-stops and avoid delays in obtaining the marketing authorization.
1.2
2.2
DEVELOPMENT OF LOCAL DOCUMENTS
ISSUANCE OF THE MARKETING AUTHORIZATION
In parallel, our team prepares a package of documents adapted to the requirements of the Authority:
The final stage – issuance of the marketing authorization of the Republic of Kazakhstan, which confirms the safety, efficacy and quality of the product and grants the right to market it in the territory of the country. The marketing authorization is issued in electronic form, and the product data are entered in the State Register of Medicines and Medical Devices.
- Development of the Normative Document
- Development of the PIL and SmPC
- Translation of documentation into the Kazakh and Russian languages
- Notarization of dossier sections and preparation of 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
140 working days
up to 45 days
up to 10 working days
Preparation of the dossier, reference standards and samples
Duration – from 1 to 12 months
Duration – from 1 to 12 months
Stage #II
Submission of the dossier and samples, examination and registration
Duration – up to 10 working days for submission, 140 working days for examination / 7 months*
*excluding clock-stops (time for addressing deficiency letters).
Including clock-stops – up to 275 working days / 13 months
Duration – up to 10 working days for submission, 140 working days for examination / 7 months*
*excluding clock-stops (time for addressing deficiency letters).
Including clock-stops – up to 275 working days / 13 months
The foundation of the registration procedure. Many of the deficiencies that cause the examination to drag on for months originate right here, before submission. We know which nuances are critical for the experts of the Authority, and we build the dossier so that as few questions as possible arise during the examination.
Once the dossier is fully assembled, the documents, reference standards and samples are officially submitted to the Authority, and the examination procedure established by the legislation of the Republic of Kazakhstan begins.
You don't need to figure out the national specifics – that is our area of responsibility. 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
Unavailability of samples and reference standards for laboratory testing
Possibility of carrying out laboratory testing directly at the manufacturing site.
Long lead times for the manufacturer's responses to the deficiency letters of the Authority
Preparation of a maximally complete dossier to preclude queries from the Authority. Informing the manufacturing site about possible queries at the dossier preparation stage.
Lengthy development and revision of packaging mock-ups
Advance request, daily communication with the manufacturer during revisions, and the option of having the mock-ups developed by Registrarius Pharm Expert.
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 product launch. We understand this and therefore work with full responsibility for every stage and every document.
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 product launch. We understand this and therefore work with full responsibility for every stage and every document.
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 KAZAKHSTAN
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 national registration of medicines in Kazakhstan
How long does the national registration of a medicinal product in Kazakhstan take?
Submission of the dossier and materials takes up to 10 working days, and the examination takes 140 working days excluding clock-stops. Including the time for addressing deficiency letters, the timeline is up to 275 working days.
In what format is the registration dossier prepared for Kazakhstan?
For national registration, a registration dossier in CTD format is compiled, and reference standards and samples are requested. In parallel, the Normative Document, PIL and SmPC are developed, and the documentation is translated into the Kazakh and Russian languages.
What stages does the examination of a medicinal product in Kazakhstan consist of?
The examination includes an initial examination (verification of dossier completeness), a specialized examination, laboratory testing of samples and preparation of the conclusion on safety, efficacy and quality. At each stage, the experts may issue deficiency letters.
What should I do if there are no samples and reference standards for laboratory testing in Kazakhstan?
The absence of samples and reference standards is listed on the page as a common risk. As a solution, laboratory testing can be carried out directly at the manufacturing site.
In what form is the marketing authorization of the Republic of Kazakhstan issued?
The marketing authorization is issued in electronic form and grants the right to market the product in the territory of the country. The product data are entered in the State Register of Medicines and Medical Devices.
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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Contract signing
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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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