OF MEDICINES IN
MONGOLIA
MONGOLIA
REGISTRATION OF MEDICINES IN MONGOLIA
Planning to launch a medicinal product on the market of Mongolia?
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.
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.
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 registration of your product in Mongolia. 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 14 DAYS
Submission of the dossier and samples for registration
FROM 12 TO 14 MONTHS
Examination procedure and issuance of the marketing authorization
Planning to launch a medicinal product on the pharmaceutical market of Mongolia? We have prepared for you a clear breakdown of all stages of state registration.
Our experience in the registration of medicines is backed by proven procedures and realistic timelines. Only working solutions, no inflated promises.
Our experience in the registration of medicines is backed by proven procedures and realistic timelines. Only working solutions, no inflated promises.
STATE 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 state registration of the product is formed: the registration dossier, reference standards and samples are collected
Timelines depend directly on how quickly the manufacturer provides the complete package of documents, reference standards and samples, and 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, and we, in turn, shorten them by giving the manufacturing site precise and clear requirements from the outset.
The most critical stage. MMDRA experts carry out a comprehensive review of the product dossier and samples The examination takes place in several stages: an initial check of the completeness of the dossier and an examination of the quality, efficacy and safety of the product, following which the decision on registration is made by the Human Medicines Council. At each stage, the experts may issue deficiency letters, and the speed and quality of the responses determine the overall registration timeline. Our specialists promptly address all queries and deficiencies to minimize clock-stops and avoid delays in obtaining the marketing authorization.
1.2
2.2
ADAPTATION OF DOCUMENTS TO THE REQUIREMENTS OF MONGOLIA
ISSUANCE OF THE MARKETING AUTHORIZATION
In parallel, our team prepares a package of documents adapted to the requirements of the Medicines and Medical Devices Control and Regulatory Agency (MMDRA):
The final stage – based on a positive decision of the Human Medicines Council, the product is entered in the State Register of Medicines of Mongolia, and the applicant is issued a marketing authorization valid for 5 years, granting the right to import and market the product in the territory of Mongolia.
- Translation of the instructions for medical use into Mongolian
- Preparation of the labeling text in accordance with the requirements of the legislation of Mongolia
- Preparation of the summary of product characteristics (SmPC) for entry into the Licemed system
- 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
on average 12–14 months
up to 30 days
after the Council's decision
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 14 days for submission, on average 12–14 months for examination and registration*
*based on practice, including the time for addressing deficiency letters (clock-stop).
The exact timeline depends on the number and complexity of the experts' deficiency letters
Duration – up to 14 days for submission, on average 12–14 months for examination and registration*
*based on practice, including the time for addressing deficiency letters (clock-stop).
The exact timeline depends on the number and complexity of the experts' deficiency letters
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 Medicines and Medical Devices Control and Regulatory Agency of Mongolia (MMDRA) via the Licemed electronic system.
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
Inaccurate translation of the instructions into Mongolian
Professional translation and verification against the manufacturer's source documents before submission of the dossier to MMDRA.
Errors when entering data into the Licemed system
Preliminary verification of the dossier data and SmPC for compliance with the system requirements before they are entered and submitted.
Late provision of samples or responses to expert queries by the manufacturer
Informing the manufacturer about possible queries at the dossier preparation stage and monitoring the timelines for providing samples and responses.
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
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 registration of medicines in Mongolia
How long does it take to register a medicinal product in Mongolia?
Up to 14 days are allowed for submission; in practice, examination and registration take on average 12–14 months, including the time for addressing deficiency letters. The exact timeline depends on the number and complexity of the experts' deficiency letters.
Where and how is the registration dossier submitted in Mongolia?
The documents, reference standards and samples are submitted to the Medicines and Medical Devices Control and Regulatory Agency of Mongolia (MMDRA) via the Licemed electronic system. Errors when entering data into Licemed are one of the common risks, so the data are checked in advance.
Who decides on the registration of a medicine in Mongolia?
The decision on registration is made by the Human Medicines Council. After a positive decision, the product is entered in the State Register of Medicines of Mongolia, and the applicant is issued a marketing authorization valid for 5 years.
Which documents need to be adapted for the registration of a product in Mongolia?
The instructions for medical use are translated into Mongolian, the labeling text is prepared in accordance with the legislation of Mongolia, and the SmPC is prepared for entry into the Licemed system. Dossier sections are also certified and the application is prepared.
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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Guaranteed deadlines
Planning negotiations.
Contract signing
Contract signing
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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