Establishment of new registration

 

Import and sale of cosmetic products is allowed only after issue of sanitary-epidemiological conclusion, that confirm quality and safety of products. Issue of these conclusions is perfromed by authorized expert organizations of State Sanitary-Epidemiological Agency of Ministry of Health of Ukraine. Conclusion is issued on results of expertise of documentation and laboratoryr analysis of samples of product. 

Sanitary-epidemiological conclusion is issued first time for period of 2 years. After end of that period Applicant is allowed to perform re-registration for next 3 years. 

Conclusion can include significant list of products. If your product line include several products, or tens of products - all of them, or almost all can be included to one conclusion. 

Conclusion include information on trade names and forms of products, manufacturer, Applicant (owner) of conclusion, requirements to quality of finished product. 

Establishment of new registration  | Cratia

NB! Some cosmetic products (soap, shampoo, hair colorants, products for hair curling) also require certification for national compliance.  

Cratia will organize procedure of sanitary-epidemiological expertise for cosmetic products. We are experienced team of professionals with excellent knowledge of legislation and outstanding relations with state authorities. Knowledge of regulatory and customs requirements guarantee that marketing authorization of cosmetic products will be correct and quick. 

 

Process of cooperation with new Customer is as follows: 

You contact us by telephone +38 (044) 221-71-29, 332-42-94,  e-mail info@cratia.ua or appoint meeting in our office
 
We check preliminary information (list of products, composition, any other information) and confirm that product(s) can be approved as cosmetics.
 
Then you send us documents in hard of electronic format according to the list of necessary materials. We usually suggest our Customer to send us scanned documents by e-mail, we check them and give our approval to send documents in paper form by courier.
 
After we receive most of required documents - we prepare the Application form and send to Customer for approval.
 
Conducting of in-registration laboratory analysis require samples of finished product. Cratia has accreditation of customs of Ukraine and can manage import of non-registered samples. 
 
Documents that we have received from you we will translate and fill according to local legal requirements to the registration dossier. Dossier will be submitted to authorized expert organization of State Sanitary-Epidemiological Agency of Ministry of Health of Ukraine. We will require Power of Attorney to act as your representative in state authorities of Ukraine. 

As a result of positive documentary expertise and laboratory analysis of samples - draft of marketing authorization certificate will be issued. Draft will be also adopted with Customer, then we receive original certificate and package labeling. 

We also provide you with post-approval assistance related to development of package mock-ups and will provide with necessary consultance in questions related to authorization, import and sales of the product. 

First contact

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Receipt, internal expertise of documentation

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Agreement

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Filling the Application (dossier), import of samples

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Submission to Ministry of Health

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Specialized expertise of documents and laboratory analysis

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Receipt of original certificate

Budget of martketing authorization of cosmetic products in Ukraine depends on several factors: 

  • Quantity of products that should be submitted at the same time (as more your order - as bigger discounts we provide); 
  • Language of documents (necessity of translations), necessity of import of samples etc.

Time to obtain approval for registration is app. 2-3 weeks from the date of submission of registration materials to Ministry of Health. 

All our obligations, timing, budgets and other key points will be justified by Agreement for  organization of state registration of food supplement. Usually we follow such terms of payment: 

  • Prepayment as of 60% of adopted budget before submission of Application to Ministry of Health; 
  • Payment as of 40% of adopted budget after receipt of originals; 

We are open for negotiations regarding payment terms. We accept cooperation with resident as well as with non-resident (EURO, USD or RUR). 

 

It is obvious that we provide all preliminary advices and calculation of the budget free of charge. 

For any issues contact us by telephone +38 (044) 221-71-29, 332-42-94, or by e-mail info@cratia.ua or at the meeting in our office