OF MEDICINAL PRODUCTS IN
THE EAEU
THE EAEU
RECOGNITION
Already hold an EAEU marketing authorization and planning to launch your product on the markets of other Member States of the Union?
You’ve come to the right place. Registrarius Pharm Expert will guide your product through the recognition procedure in the Member State of recognition - from preparation of the document package to obtaining an EAEU marketing authorization valid in the territory of the Member State of recognition. 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.
You’ve come to the right place. Registrarius Pharm Expert will guide your product through the recognition procedure in the Member State of recognition - from preparation of the document package to obtaining an EAEU marketing authorization valid in the territory of the Member State of recognition. 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»
Upon receipt of your request, we will prepare a personalized commercial proposal with a detailed calculation of the full budget for the recognition procedure of your product in an EAEU Member State. 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 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 recognition procedure, prompt feedback, and support at every stage of interaction with the Authority.
PROJECT EXECUTION
[03]
1-3 MONTHS
Preparation of the document package in accordance with the requirements of EEC
UP TO 1 MONTH
Submission of the document package for registration under the recognition procedure
FROM 40 TO 220 working days
Examination and registration procedure (including clock-stop)
Already hold an EAEU marketing authorization and planning to expand into other countries of the Union?
We have prepared for you a clear breakdown of all stages of the recognition procedure for medicinal products in accordance with EAEU rules.
We have prepared for you a clear breakdown of all stages of the recognition procedure for medicinal products in accordance with EAEU rules.
RECOGNITION PROCESS FOR MEDICINAL PRODUCTS IN THE EAEU
1.1
RECEIPT OF MATERIALS FROM THE MARKETING AUTHORIZATION HOLDER
- EAEU marketing authorization issued by the reference Member State
- Expert report (or an extract from it) prepared by the Authority of the reference Member State
- Approved documents (SmPC, PIL, NQD, packaging mock-ups)
- EAEU GMP certificate(s) for the manufacturing sites (where available)
- Power of attorney for recognition of the registration from the marketing authorization holder (apostilled)
– at this sub-stage, the basis for recognition of the registration in the EAEU Member State is formed:
1.2
ADAPTATION OF DOCUMENTS TO THE REQUIREMENTS OF THE MEMBER STATE OF RECOGNITION
– in parallel, our team prepares a package of documents adapted to the requirements of the Authority of the Member State of recognition:
- Translation of the SmPC / PIL into the state language of the Member State of recognition
- Adaptation of the packaging mock-ups to the requirements of the Member State of recognition
- Preparation of the application for recognition of the registration
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.
1–3 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 examination under the recognition procedure
2.2
UPLOADING THE DOSSIER TO THE ONLINE PORTAL
Once payment is received by the Authority, access to the portal is granted. The electronic application for recognition of the registration is completed, and the set of documents is uploaded in the format established by the Authority of the Member State of recognition
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 application for registration under the recognition procedure
Duration - up to 1 month
Duration - up to 1 month
3.1
EXAMINATION OF THE DOSSIER
- Conformity of the data with the expert report of the reference Member State
- Completeness and correctness of document formatting
- Compliance of the labeling and packaging, PIL, SmPC with the requirements of the Member State of recognition
- User testing of the PIL (where necessary)
- assessment of the dossier documents and data for safety, efficacy, and quality
3.2
ISSUANCE OF THE EAEU MARKETING AUTHORIZATION FOR THE MEMBER STATE OF RECOGNITION
The final stage - issuance of the document confirming the right to market the product in the territory of the Member State of recognition. Following a positive conclusion, the Authority enters the data in the Unified Register of Registered Medicinal Products of the Union, and the marketing authorization holder becomes legally entitled to import and sell the product in the territory of the Member State of recognition
STAGE #III
30 working days
Clock-stop - 180 working days
Clock-stop - 180 working days
10 working days
Registration recognition procedure
Duration - 40 working days/2 months*
*excluding clock-stops (time for addressing deficiency letters)
Including clock-stops at each stage - maximum of 220 working days / 10 months
Duration - 40 working days/2 months*
*excluding clock-stops (time for addressing deficiency letters)
Including clock-stops at each stage - maximum of 220 working days / 10 months
Получение одобрения от Уполномоченного органа Длительность — до 10 рабочих дней
The foundation of the recognition procedure. The completeness and correctness of the document package at this stage determine how smoothly the examination in the Member State of recognition will proceed. We know which documents and data from the reference Member State are required, and we help the marketing authorization holder assemble the package without errors or rework.
Once the document package is fully assembled, the official submission of the application to the Authority of the Member State of recognition begins.
Examination under the recognition procedure. The Authority of the Member State of recognition assesses the conformity of the submitted documents with the data contained in the expert report of the reference Member State, without repeating a full specialized examination. Our specialists promptly address all queries to minimize clock-stops.
Timelines depend directly on how quickly the marketing authorization holder provides the complete package of documents, as well as on how promptly the Authority of the reference Member State transfers the expert report.
Timelines can be shortened if the marketing authorization holder provides source materials in advance.
Common Registration Risks
and Ways to Overcome Them
and Ways to Overcome Them
Non-conformity of the data in the documents submitted for recognition with the expert report of the reference Member State
Bringing the document package into full conformity with the dossier and the conclusion of the reference Member State prior to submission
Differences in the labeling and state language requirements in the Member State of recognition
Advance translation and adaptation of the SmPC / PIL and packaging mock-ups to the requirements of the Member State of recognition
Delays by the manufacturer in providing responses to the queries of the Authority
Preparation of the most complete dossier possible to preclude queries from the Authority. Informing the manufacturer about possible queries at the dossier preparation stage.
Delays by the reference Member State in providing the expert report
Requesting materials in advance and monitoring interaction timelines between the Authorities
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 30
successful internal audits with a positive conclusion under GXP, GRP, and GVP.
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
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
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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