Baby food

Baby foods, depending on the age and needs of the child, are divided into several main groups:

  • Initial (starter) infant formulas;
  • Follow-on formulas;
  • Supplementary food;
  • Beverages;
  • Functional baby food
State registration of baby food in Ukraine  | Cratia

For the import and sale of foreign-made baby foods, the marketing authorization (state registration) is required. The registration is carried out by the Ministry of Health of Ukraine on the basis of expert review of the documents, laboratory analysis, and conclusion of a specialized commission for paediatrics. Subsequently, a certificate is issued for the period of up to 5 years. Baby foods are also subject to certification of conformity.

Cratia provides services for organizing the state registration of baby foods. We have vast experience in registration, possess excellent knowledge of Ukrainian and international legislation, maintain good relations with state authorities and expert organizations, we are familiar with the customs requirements and can perform the registration of baby foods correctly, to a high standard, and quickly. Since 2005, we have carried out the registration of more than 100 products.

Procedure of cooperation with new Customer in brief: 

You contact us at the telephone: +38 (044) 221-71-29, 332-42-94,  via e-mail: info@cratia.ua or arrange for a visit to our office

We review the initial information on the product (composition, recommendations for use, clinical studies). Next, you provide us with the documents according to the list in either paper or electronic form. In order to accelerate the document preparation and approval, we usually offer that at first you send us the copies of the documents by e-mail and only after their verification and approval you provide us with the original hard copies.

Upon receipt of the documents we will draft an Application and the package labeling and send them to you for approval.

The labeling approval is followed by submission of documents to the specialized commission for paediatrics to obtain an opinion on the baby foods in question. The expert examination is performed by the organizations authorized by the Ministry of Health. The conclusion of the commission is issued following the technical review of the documentation, and in cases where no clinical studies have been conducted – following conduct of clinical studies at the premises of an accredited institution.

For laboratory analysis, the finished product samples are required. Cratia is accredited by the customs service of Ukraine and will import samples on its behalf.

The baby food registration materials obtained from you will be compiled in accordance with the requirements of Ukrainian legislation, translated, where required, and submitted to the Ministry of Health of Ukraine and the expert commission for paediatrics for review. To represent your interests at the Ministry of Health and expert organizations, we will need a Power of Attorney.

Following the primary expert examination, we will obtain a referral to a specialized expert evaluation and laboratory analysis.

In the course of the specialized evaluation, corrective amendments may be made to the draft labeling at the discretion of the expert organization. All changes and proposals are to be agreed upon with the Customer.

Following a positive conclusion of the expert review of the documents and the laboratory analysis of samples, a draft Conclusion is issued. This draft shall also be agreed upon with the Customer, whereafter we will receive the original Certificate and package labeling. 

We will also assist you with the product labeling in the following: we will review the package design for conformity with the documents approved and give you all necessary advices on the product registration. 

First contact

State registration of baby food in Ukraine  | Cratia 2

Receipt, internal expertise of documentation

State registration of baby food in Ukraine  | Cratia 2

Agreement

State registration of baby food in Ukraine  | Cratia 2

Filling the Application (dossier), import of samples

State registration of baby food in Ukraine  | Cratia 2

Submission to Ministry of Health

State registration of baby food in Ukraine  | Cratia 2

Specialized expertise of documents and laboratory analysis

State registration of baby food in Ukraine  | Cratia 2

Receipt of original certificate:

State registration of baby food in Ukraine  | Cratia 8

 

The budget for registration of a baby food depends on several factors:

  • Product complexity (multicomponent composition implies higher costs);
  • Whether any clinical studies of the product have been performed;
  • Number of products submitted for authorization (the larger your order is, the larger discounts we provide);
  • Language of the documents (whether translation is required), need to import the product samples, etc.

The term of registration is approximately 2 months from the date of submission of the registration materials to the MOH.

The collaboration implies conclusion of an Agreement for organization of the state registration, in which we will specify all obligations in terms of scope of work, costs and completion periods. Our services should be paid for as follows:

  • Prepayment of 60% of the agreed cost prior to submission of the documents to the MOH;
  • Payment of 40% of the agreed cost following receipt of the originals;

Where necessary, we can negotiate another manner of payment. We accept the payment both in UAH from the residents or in EURO/USD from non-residents, as by Agreement.

Needless to say, we provide all preliminary consultations and perform calculation of costs for free.

You can get a consultation by contacting us at the telephone:  +38 (044) 221-71-29, 332-42-94,  by e-mail: info@cratia.ua or visiting us in our office