Gaukhar Bilimbayeva, CEO of Registrarius Pharm Expert
AND REGISTRATION OF COSMETIC PRODUCTS IN THE EAEU

DECLARATION AND REGISTRATION OF COSMETIC PRODUCTS IN THE EAEU

Planning to launch cosmetic 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 dossier preparation to obtaining a declaration of conformity or a 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
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[…]
Kazakhstan
Kazakhstan
Türkiye
Türkiye
Uzbekistan
Uzbekistan
Tajikistan
Tajikistan
Georgia
Georgia
Azerbaijan
Azerbaijan
Russia
Russia
Mongolia
Mongolia
Belarus
Belarus
Turkmenistan
Turkmenistan
Moldova
Moldova
Kyrgyzstan
Kyrgyzstan
Armenia
Armenia
Ukraine
Ukraine
Upon receipt of your request, we will prepare a personalized commercial proposal with a detailed calculation of the full budget for the conformity assessment 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
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 project, 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 3 WORKING DAYS
Submission of the dossier and product samples
UP TO 14 CALENDAR DAYS
Studies, examination and assignment of a registration number
Planning to launch cosmetic products or oral hygiene products on the market of the Eurasian Economic Union countries? We have prepared for you a clear breakdown of all stages of the procedure.

Our experience in the conformity assessment of cosmetic products is backed by proven procedures and realistic timelines. Only working solutions, no inflated promises.
DECLARATION AND REGISTRATION PROCESS FOR COSMETIC PRODUCTS
1.1
RECEIPT OF THE DOSSIER AND SAMPLES FROM THE MANUFACTURER
At this sub-stage, the basis for the conformity assessment of the products is formed: a preliminary check of the composition is carried out, and the product dossier and samples for sanitary and hygienic studies are collected in accordance with the requirements of TR CU 009/2011.

Timelines depend directly on how quickly the manufacturer provides the complete package of documents and product samples.
1.2
DEVELOPMENT OF LOCAL DOCUMENTS
In parallel, our team prepares a package of documents adapted to the requirements of the Authority:

  • Development of packaging mock-ups and instructions for use
  • Translation and notarization of the dossier
  • Preparation of the application for conformity assessment

The timeline can be shortened if the manufacturer provides source materials in advance.
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 20 days
Preparation of the dossier and local documents
Duration – from 1 to 12 months
Stage #II
Submission of the dossier and product samples
Duration – up to 3 working days
Stage #III
The final stage – registration of the declaration of conformity or issuance of the State Registration Certificate with assignment of a registration number. The data are entered in the unified EAEU register, which allows the products to be imported and sold in all Member States of the Union without repeating the procedure.
ASSIGNMENT OF A REGISTRATION NUMBER AND ISSUANCE OF THE PERMIT DOCUMENT
Studies, examination and assignment of a registration number
Duration – up to 14 calendar days
Obtaining approval from the Authority Duration — up to 10 working days
The foundation of the procedure. The completeness and correctness of the dossier at this stage determine how smoothly the studies and the examination will proceed. We know which documents, materials and product samples are required, and we help the manufacturer assemble the package without errors or rework.
Once the dossier is fully assembled, the documents and product samples are officially submitted to the Authority, and the studies and examination procedure begins.
The most critical stage. Accredited laboratories carry out sanitary and hygienic studies of the products, while the Authority assesses their composition, labeling and packaging for compliance with the requirements of TR CU 009/2011. Our specialists promptly address all queries to minimize timelines.
Common registration risks
and ways to overcome them
Non-compliance of the qualitative composition of the products with the requirements of TR CU 009/2011
Preliminary review of the composition and formulation before the official submission of documents, to identify all non-conformities in advance.
Incorrectly determined form of conformity assessment — declaration instead of state registration
Determining the applicable form of conformity assessment at the start of the project: certain categories of cosmetic products are subject to state registration rather than declaration.
Labeling and packaging mock-ups do not comply with EAEU requirements
Development and adaptation of the mock-ups in parallel with dossier compilation, before submission of documents.
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 State Registration Certificate, 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.
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 COSMETIC PRODUCT 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
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
Outsourcing
Focus on your business, while we take care of registration and pharmacovigilance!
Learn more
Proud of our team
Learn more
Gaukhar Bilimbayeva
Gulzhan Akhmetova
Anna Polivoda
Dauren Bilimbayev
Learn more
Learn more
Maxim Sevostyanov
Bulegenova Zhadyra
Jenis Kamila
Asel Seidakhmetova
Learn more
Learn more
Learn more
Learn more
Learn more
We have over 50 international diplomas and certificates confirming our high qualifications and standards:
Training certificate
Training certificate
Training certificate
Training certificate
Training certificate
Training certificate
Training certificate
Training certificate
Training certificate
Training certificate
Training certificate
Training certificate
Training certificate
Training certificate
Training certificate
Training certificate
Training certificate
Training certificate
Training certificate
Training certificate
Training certificate
Darnitsa Pharmaceutical Company
msn laboratories
MSN Laboratories
MSN Laboratories
Our experience
medocemie
Medochemie
Medochemie
pharmalex
PharmaLex
PharmaLex
dr.theiss naturwaren
Dr. Theiss
Dr. Theiss
gsk
GSK
GSK
angelini pharma
Angelini
Angelini
orion corporation
Orion
Orion
geropharm
Geropharm
Geropharm
Darnitsa
Darnitsa
octapharma ag
Octapharma
Octapharma
sanovel
Sanovel
Sanovel
stada
STADA
STADA
grotex
fresenius
Fresenius
Fresenius
unipharm
Unipharm
Unipharm
promomed
Promomed
Promomed
Solopharm
Solopharm
mayoly
Mayoly
Mayoly
accord healthcare
Accord
Accord
agio pharmaceuticals
AGIO Pharmaceuticals
AGIO Pharmaceuticals
Client testimonials
Client testimonials

Frequently asked questions about the declaration and registration of cosmetics in the EAEU

Do cosmetics need a declaration or state registration in the EAEU?

It depends on the product category: certain categories of cosmetic products are subject to state registration rather than declaration. Therefore, the applicable form of conformity assessment is determined at the start of the project.

How long does the declaration or registration of cosmetics in the EAEU take?

Preparation of the dossier and local documents takes from 1 to 12 months, submission of the dossier and samples up to 3 working days, and studies, examination and assignment of a registration number up to 14 calendar days.

What requirements must cosmetics meet to enter the EAEU market?

The assessment is carried out according to the requirements of TR CU 009/2011: accredited laboratories carry out sanitary and hygienic studies of the products, while the Authority assesses their composition, labeling and packaging.

What document does a cosmetics manufacturer receive, and where is it valid?

Upon completion, a declaration of conformity is registered or a State Registration Certificate with an assigned registration number is issued. The data are entered in the unified EAEU register, which allows the products to be sold in all Member States of the Union.

What mistakes are most common in the conformity assessment of cosmetics?

Common risks are non-compliance of the qualitative composition with the requirements of TR CU 009/2011, an incorrectly chosen form of conformity assessment, and labeling that does not comply with EAEU requirements. The composition is checked before submission, and the mock-ups are adapted in parallel with the dossier.

REGISTRARIUS PHARM EXPERT office in Uzbekistan
REGISTRARIUS PHARM EXPERT office in Kazakhstan
Tashkent, 100000,
2 Quruvchi Massiv
Sales hotline: +7 (700) 178-67-67
Mail: 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
Group
mon
tue
wed
thu
fri
sat
Group
mon
tue
wed
thu
fri
sat
Group
mon
tue
wed
thu
fri
sat
Outsourcing with Registrarius Pharm Expert is simple and fast:
I
II
III
Group
mon
tue
wed
thu
fri
sat
Group
mon
tue
wed
thu
fri
sat
Guaranteed deadlines
Planning negotiations.
Contract signing
Handover. Project launch
Monthly reports.
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!
Outsourcing
Group
mon
tue
wed
thu
fri
sat