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CRO in Russia - Clinical Excellence Group (CEG)

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Registration and Obligatory Declaration of
Parfumery and Cosmetic Products
in Russia, Belarus and Kazakhstan

Your company will launch new parfumery and cosmetic products to the united market of Russia, Belarus and Kazakhstan within 2.5 months. All stages are in time.
You will enjoy the quality and reliability of our services and our commitment to result.

Russian Market
The European market of cosmetics and personal care products is estimated at €78 billion and growing at 1.3% in 2017.

The Russian cosmetics and personal care market is estimated at about 388 billion Rub. (€5.6 billion) in 2017 and it is the #6 in Europe. The market keeps growing by 5-8% annually.

About 183 million packages were sold by drug stores only in Russia. Sales exceeded 44 billion Rub. (€640 million): mass-market - 14.9%, cosmetics for medical usage - 48.1%, premium and lux cosmetics - 37.2%.

The impressive market size is determined by numerous factors, with the primary one being the total population - 143.5 million people (according to the Federal State Statistics Service as of August 1, 2013). 30%+ of the population are females between the ages of 20 and 60 y.o.

There are following trends on the market:
✔ natural, organic cosmetics and products for medical usage segments rise faster;
✔ online sales rase faster than offline;
✔ a slight decrease in direct sales;
✔ skin care products segment is still the largest one.

Read more on the following web resources:
DMS Group - Annual Report [in Rus],
AdIndex Market [in Rus],
The Cosmetic Toiletry & Perfumery Association (CTPA),
Premium Beauty News,
Fashion Network

The population of EAEU is 185+ mln. people. Russia is a largest country of the Union.
One third of the population are females between the ages of 20 and 60 y.o.

Since July 1, 2012, regulation on registration and circulation of cosmetic products have been changed considerably by the Technical Regulation of the Customs Union TR TS 009/2011 [in Russian] "On safety of perfumery and cosmetic products".
Thus, the united market of the Customs Union were established.

It means that if your company registers a dietary supplement in Russia, it can also sell this product in Belarus (about 9.5 million people) and Kazakhstan (about 17.2 million people), i.e., on the market of more than 180 million people! In the coming years, the list of the Customs Union members is expected to be extended by candidate countries.

There are two types of cosmetics' market authorization: state registration and obligatory declaration. The choice between them depends on the type of product.

The following types of perfumery and cosmetic products are subject to the state registration:
  1. Perfumery and cosmetic products for sunless tanning.
  2. Perfumery and cosmetic products for skin lightening (whitening).
  3. Permanent cosmetics.
  4. Intimate cosmetics.
  5. Perfumery and cosmetic products for individual skin protection from harmful workplace exposures.
  6. Children's cosmetics.
  7. Perfumery and cosmetic products for chemical hair dying, lightening and highlighting.
  8. Perfumery and cosmetic products for chemical hair waving and straightening.
  9. Perfumery and cosmetic products produced with nanomaterials.
  10. Perfumery and cosmetic products for hair removal.
  11. Exfoliating products.
  12. Fluoride-containing oral care products with a mass fraction of fluorides greater than 0.15% (0.05% for liquid oral care products).
  13. Teeth whitening products containing hydrogen peroxide or other components that produce hydrogen peroxide, including carbamide peroxide and zinc peroxide, with a concentration of hydrogen peroxide (as an ingredient or product) of 0.1% to 6.0%.

All other types of cosmetics must be authorized by the obligatory declaration procedure.

Visit the Information Portal of the Union.

Key Stages of the State Registration

Preliminary examination +
Preparation of the registration dossier
3 weeks
Import of samples (if manufactured outside Russia) +
Quality and safety testing in accredited laboratories
2-4 weeks
State registration of cosmetics by Rospotrebnadzor
3-4 weeks

Key Stages of the Obligatory Declaration

Preliminary examination +
Preparation of the dossier for the declaration
2 weeks
Import of samples (if manufactured outside Russia) +
Quality and safety testing in accredited laboratories
2-3 weeks
Obligatory Declaration of cosmetics by accredited institution
1-2 weeks
Registration/ Declaration Procedure
Registration / declaration of cosmetics is a multi-stage process that results in obtaining the Marketing Authorization:
✔ the State Registration Certificate issued by the Federal Service for Supervision of Consumer Rights Protection and Human Welfare (Rospotrebnadzor);
✔ the Declaration of Conformity to TR TS 009/2011.

In order to successfully launch a perfumery or cosmetic product to the Customs Union market, one needs to verify, whether a product can be registered as a perfumery or cosmetic product, to prepare and submit a registration dossier, to conduct sample testings (in the scope determined by product ingredients, route of administration, product safety and quality), to organize the import of a product to Russia (if needed) and to communicate with Rospotrebnadzor and accredited expert laboratories.

See what we can offer.
We guarantee: within 2.5 months, your company will launch new parfumery and cosmetic products to the united market of Russia, Belarus and Kazakhstan.
All work stages from the idea to receipt of the Marketing Authorizations will be completed as scheduled.
You will enjoy the quality and reliability of our services and our commitment to result.

How can we help your company?

We make a preliminary examination of the cosmetic products' composition and quality (to determine the possibility of launching them as porfumery and cosmetic products via state registration or obligatory declaration).
If needed: we make marketing study for your company's products and determine competitors and their sales (through drug stores only).
If needed: we develop sales and financing plan, estimate financial indicators, taking into account product strategy and expenses after product launch.
We develop a project plan for the state registration or obligatory declaration of the products.
We organize the translation of all source documents into Russian.
We make sample testing in accredited expert laboratories.
We provide consultation on national regulations to manufacturing and quality of cosmetics.
We submit the dossier(s) and represent your company during review (examination) by Rospotrebnadzor.
We develop documents of the registration dossier(s).
We obtain the Marketing Authorizations (the State Registration Certificates or the Declarations of Conformity to TR TS 009/2011) valid in Russia, Belarus and Kazakhstan.

What you get when you work with us?

You use our expertise when it comes to blind spots.
We will work together to define your goals and will develop an optimal plan for registration of your products and the scope of necessary sample testing.
Executive staff and key specialists of the CEG company have profound knowledge and vast experience in registration of cosmetics. You can see for yourselves when you receive answers to your questions or, for a start, take a look here.
The state registration is completed within 2.5 months and your company can start selling.
It will take 2.5 months to obtain a Marketing Authorization (State Registration Certificate) if good source documents are available. In more complicated cases, it may take a month more to complete the project. The declaration takes about 1.5 months in total.
You will know all details of your project before its start and before we sign a contract. More predictability - less problems!
In only 3-5 days after contacting us and discussing the details you will receive the budget and plan of your project (even if it involves registration of multiple products).
We know that it is crucial to understand what investments are needed and at what stages and how long the whole registration / declaration process will take.
And yes, it is free of charge.
We cooperated with 4 companies for the registration of their cosmetics
Additionally, our specialists on registration and regulatory affairs have organized the registration of hundreds of cosmetic products in Russia, Ukraine and Kazakhstan.
Right proportion of price and quality.
The cost of "turnkey" projects on registration / declaration of cosmetic products depends on the extent of product sample testing and the completeness of a dossier draft.
We will only need 3-5 days to communicate you the precise cost for registration / declaration of your products.
Mid-market prices of our services combined with their high quality are a strong argument to work with us.
We carefully listen to our clients and usually respond to the query in 24 hours
So you can always be sure that the solution of current issues is not being delayed.
CEG has standardized business processes, so that you can be confident in quality and timeliness of accomplishing your goals.
Our work is guided by standards established at the market of drug registration and studies.
This goes for development and implementation of Standard Operating Procedures (SOPs), organization of staff training, logistics.
This is an additional guarantee of your project's success.
Our team is constantly improving. And we really mean it.
Sex of our specialists have more than 7 years of work experience in pharmaceutical companies and international contract research organizations, four specialists have more than 12 years of experience.
Our managers on registration and regulatory affairs attend workshops and conferences.
Every year our company's staff takes an assessment test of knowledge of Standard Operating Procedures and the legislation of Russia and the Eurasian Economic Union / Customs Union.

Contact Us

It is easy, convenient and only takes a few minutes.
Please send us your comments, questions, suggestions, information about you company and products for the state registration through this form. Leave your contact information and we will respond within 24 hours.
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