OF MEDICINES PRODUCTS IN
THE EAEU
THE EAEU
REGISTRATION
Planning to launch a medicinal product on the EAEU market?
You’ve come to the right place. Registrarius Pharm Expert will guide your product through the entire regulatory pathway - from registration dossier preparation to marketing authorization issuance.
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 EAEU and CIS countries.
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 LLP, Head of Registration and Pharmacovigilance, PharmD, MBA
CEO of Registrarius LLP, Head of Registration and Pharmacovigilance, 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
«We provide registration and pharmacovigilance services in the CIS countries, the EAEU, and Mongolia»
Registration by country
Timelines, requirements and steps of medicine registration in each country:
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 the EAEU. No hidden fees - you see the final price before the contract is signed.
PARTNERSHIP MODEL WITH REGISTRARIUS PHARM EXPERT
COMMERCIAL PROPOSAL
[01]
Dauren Bilimbayev
Founder
Founder
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 LLP 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]
1–12 MONTHS
Preparation of the registration dossier, samples, and reference standards in accordance with EEC Council Decision
No. 78.
No. 78.
UP TO 1 MONTH
Submission of the dossier for registration
FROM 140 TO 410 WORKING DAYS
Examination and registration procedure (including clock-stops)
Planning to launch your medicinal products on the pharmaceutical market of the Eurasian Economic Union (EAEU)?
We have prepared for you a clear breakdown of all stages
of the registration of medicines in accordance with EAEU rules.
Our experience is based on more than 300 successful submissions across the Union. Only realistic timelines, proven procedures,
and working solutions.
We have prepared for you a clear breakdown of all stages
of the registration of medicines in accordance with EAEU rules.
Our experience is based on more than 300 successful submissions across the Union. Only realistic timelines, proven procedures,
and working solutions.
REGISTRATION PROCESS FOR MEDICINES IN THE EAEU
1.1
RECEIPT OF THE DOSSIER, REFERENCE STANDARDS AND SAMPLES FROM THE MANUFACTURER
- EAEU CTD dossier in PDF format
- Samples and reference standards for analysis in triplicate
- GMP certificate(s) for the manufacturing sites, issued by the Competent Authority of the manufacturer's country and CPP (where available) - apostilled
- EAEU GMP (where available)
- Power of attorney for registration from the manufacturer or marketing authorization holder (apostilled)
- Manufacturing Authorization
– at this sub-stage, the basis for the registration of the medicinal product in the EAEU is formed:
1.2
DEVELOPMENT OF LOCAL DOCUMENTS
– in parallel, our team prepares a package of documents adapted to the requirements of the EAEU and the regulator:
- Development of the EAEU Normative Quality Document (NQD)
- Packaging mock-ups
- Development of the EAEU SmPC / PIL
- Translation into the State language / Russian language
- Notarization of dossier sections
- Calculation of the required quantity of samples
- Obtaining an import permit for samples and reference standards
STAGE #I
Each of the above stages has its own processes, deadlines, nuances, and risks, which we will help you successfully overcome with maximum benefit. Each of the above stages has its own processes, deadlines, nuances, and risks, which we will help you successfully overcome with maximum benefit. Each of the above stages has its own processes, deadlines, nuances, and risks, which we will help you successfully overcome with maximum benefit.
1–12 months
up to 45 days
Preparation of dossiers, standards and samples
Duration - from 1 month up to 1 year
Duration - from 1 month up to 1 year
2.1
CONCLUSION OF THE CONTRACT WITH THE AUTHORITY
and receipt of the invoice for payment of the EAEU registration examination.
2.2
UPLOADING THE DOSSIER TO THE ONLINE PORTAL
Once payment is received by the Authority, access to the portal is granted. At this stage, the electronic application for the EAEU registration of the medicinal product is completed, and the full set of the registration dossier is uploaded in EAEU XML format for further examination under the EAEU procedure.
STAGE #II
up to 14 days
up to 14 days
2.3
PROVISION OF REFERENCE STANDARDS AND SAMPLES
after completion of the validation of the registration dossier.
up to 3 days
Submission of the dossier and materials for registration
Duration - up to 1 month
Duration - up to 1 month
3.1
INITIAL EXAMINATION
- Completeness
- Package completeness (set of documents)
- Correctness of document formatting
- assessment of the dossier documents and data for safety, efficacy, and quality:
- assessment of the dossier completeness
3.2
SPECIALIZED EXAMINATION
- Pharmacological
- Pharmaceutical
- Laboratory testing (verification, on samples of the medicinal product, of the reproducibility of the analytical methods specified in the Normative Document)
- Translation of the SmPC / PIL into the state language and verification of the correctness of the mock-up text
STAGE #III
15 working days
Clock-stop - 90 working days
Clock-stop - 90 working days
105 working days
Clock-stop - 180 working days
Clock-stop - 180 working days
3.3
APPROVAL OF THE EXPERT REPORT
Preparation of the final expert report based on the results of all examinations performed - the final document on which the registration decision is based.
The final stage - issuance of the document that grants the product access to the pharmaceutical markets
of all EAEU Member States.
Following a positive expert report, the Authority issues a marketing authorization of the unified EAEU format and enters the product in the Unified Register of Registered Medicines of the Union. From this moment, the manufacturer is legally entitled to import the product into the territory of the reference Member State and other EAEU Member States (under the mutual recognition procedure).
Electronic version - 10 working days
Paper version - up to 3 months
of all EAEU Member States.
Following a positive expert report, the Authority issues a marketing authorization of the unified EAEU format and enters the product in the Unified Register of Registered Medicines of the Union. From this moment, the manufacturer is legally entitled to import the product into the territory of the reference Member State and other EAEU Member States (under the mutual recognition procedure).
Electronic version - 10 working days
Paper version - up to 3 months
10 working days
3.4
ISSUANCE OF THE MARKETING AUTHORIZATION
10 working days
Registration procedure
Duration - 140 working days / 7 months*
*excluding clock-stops (time for addressing deficiency letters)
Including clock-stops at each stage - maximum of 390 working days / 18 months
Duration - 140 working days / 7 months*
*excluding clock-stops (time for addressing deficiency letters)
Including clock-stops at each stage - maximum of 390 working days / 18 months
Получение одобрения от Уполномоченного органа Длительность — до 10 рабочих дней
The basis of the entire registration. The quality of document preparation at this stage determines how smoothly all subsequent stages will proceed. We know which nuances are critical for the experts of the Authority and help the manufacturer assemble the package without errors or rework.
Once the dossier is fully assembled, the official submission of documents to the Authority of the reference Member State of the EAEU begins.
The most critical stage. Experts of the Authority carry out a comprehensive review of the product dossier 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.
Timelines depend directly on how quickly the manufacturer provides
the complete package of documents and materials, including the time
required for customs clearance of samples and reference standards
in the territory of the reference Member State.
the complete package of documents and materials, including the time
required for customs clearance of samples and reference standards
in the territory of the reference Member State.
Timelines can be shortened if the manufacturer provides source materials for document development in advance.
Common Registration Risks
and Ways to Overcome Them
and Ways to Overcome Them
Non-compliance of analytical methods with the EAEU Pharmacopoeia, absence of QOS, etc.
Justifications supported by references to EU Directives and US FDA guidance documents may be accepted by the Authority.
Inability to provide samples and reference standards.
Possibility of carrying out laboratory testing at the manufacturer's facility.
Delays by the manufacturer in providing responses to the queries of the Authority.
Preparation of a maximally complete dossier to preclude queries from the Authority. Informing the manufacturer about possible queries at the dossier preparation stage.
Absence of a bioequivalence study conducted in an EAEU Member State.
Conducting an EAEU GCP inspection during the product registration process.
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 - 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 protects you from delays, refusals, and reworks.
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 protects you from delays, refusals, and reworks.
COMPANY EXPERIENCE
successful GMP inspections by the CIS regulatory authorities.
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:
We have organized and supported inspections and audits:
More than 0
successful internal audits with a positive conclusion under GXP, GRP, and GVP.
More than 0
successful quality control inspections.
More than 0
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
Zhadyra Bulegenova
Senior Registration Specialist
Education:
2008–2012 — Al-Farabi
Kazakh National University (Bachelor's)
2012–2014 — S. Asfendiyarov Kazakh National
Medical University (Master's)
Kamila Jenis
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 drug registration in the EAEU
How long does it take to register a medicinal product in the EAEU?
Preparation of the dossier, standards and samples takes 1–12 months and submission up to 1 month. The registration procedure itself takes 140 working days (7 months) excluding clock-stops, i.e. the time for addressing deficiency letters.
What documents does the manufacturer need to provide for EAEU registration?
The manufacturer provides an EAEU CTD dossier in PDF format, samples and reference standards in triplicate, apostilled GMP certificate(s) and CPP (where available), EAEU GMP (where available), an apostilled power of attorney and the Manufacturing Authorization.
What are the stages of the EAEU registration examination?
The examination consists of an initial examination of dossier completeness, a specialized examination (pharmacological, pharmaceutical and laboratory testing of samples), approval of the final expert report, and issuance of the marketing authorization.
What does an EAEU marketing authorization allow the manufacturer to do?
The Authority issues a marketing authorization of the unified EAEU format and enters the product in the Unified Register of Registered Medicines of the Union. The manufacturer may then import the product into the reference Member State and other EAEU Member States under the mutual recognition procedure.
What if my bioequivalence study was not conducted in an EAEU Member State?
The absence of a bioequivalence study conducted in an EAEU Member State is listed among common registration risks. The solution indicated is conducting an EAEU GCP inspection during the product registration process.
REGISTRARIUS PHARM EXPERT office in Uzbekistan
REGISTRARIUS PHARM EXPERT
office in Kazakhstan
office in Kazakhstan
2 Quruvchi Massiv, Tashkent 100000, Republic of Uzbekistan
Sales hotline: +7 (700) 178-67-67
Email: 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
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 discussions. Contract signing
Handover. Project launch
Monthly reports. Online product status tracking. Participation in review meetings
Cost savings
More time for business
Lower taxes
Free up headcount
Qualified managers
Focus on your business. We’ll handle registration and PV.
Outsourcing
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