Structure of registration dossier

List of documents required for state registration of special food products (dietary supplements) in Ukraine:

I. Administrative documents & forms:

1. Power of Attorney issued on the name of Cratia (form of the document will be sent by separate document). Power of Attorney must be correctly legalized, depending on the country of origin (notary certification, Apostil or legalization at the Council of Ukraine).
2. Application in MS Word format (will be sent by separate document).

II. Official documents from Applicant (owner of the marketing authorization):

1. Official document of state registration of legal entity of Applicant (company record, notification issued by chamber of commerce etc.);
2. Document that explains relations between Applicant and manufacturer (for example – Power of Attorney, Letter of Authorization, Declaration of incorporation, part of the Agreement etc.);
3. Letter in a free form that Applicant takes responsibility for quality and safety of the marketed product; 

NB: if manufacturer is the Applicant – part II mentioned above is not needed.

III. Official documents from manufacturer:

1. Official document of state registration of legal entity of manufacturer (company record, notification issued by chamber of commerce etc.);
2. Manufacturing license (permission for manufacture of food supplements, parapharmaceutical products etc.);
3. Certificates that confirm quality management systems established on the manufacturing site: GMP, ISO or any other/similar certificates or documents;

IV. Administrative information on the product:

1. Certificate of state registration (marketing authorization) from manufacturer’s country, free sale certificate or export permission;
2. List of countries where the product obtained marketing authorization. Copies of certificates if available;
3. Package mock-ups, labeling information;
4. Summary of product’s characteristics: recommendations for use, dosage, side effects, contradictions, precautions, storage conditions and shelf-life;

V. Quality, safety and efficiency of the finished product:

1. Composition of the finished product. Composition should be specified for one unit of the finished product: tablet, capsule etc., including all excipients. If excipient has an international “E” index (E 123) – it should be obligatory specified;
2. Specification of the finished product: physical-chemical and biological requirements to the product (appearance, average weight, microbiological purity etc.). Specification should include references to the normative documents: pharmacopeia’s articles, in-house methods etc.
3. Control methods of finished product according to Specification, articles from Pharmacopeia or description of the methods;
4. Certificates of analysis (quality) on two manufacturing batches for every dosage of the finished product;
5. Declaration of radiological control and control of pesticides (for products of herbal origin) or guarantee letter regarding radiological and toxicological control;
6. Description of manufacturing process: scheme (flow-chart), description of the process, technical conditions;
7. Information regarding safety and efficiency of the product: expert reports on safety and efficiency, results of preclinical and clinical studies, literature articles and references. It is necessary to provide relevant studies in case of recommendations for pregnant or children; 
8. Guarantee letter that product does not contain medicinal components and genetically modified organisms;
9. Samples of the finished product: at least 6 packs;

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.