Structure of the dossier for cosmetic products

doc-kosmetika List of documents required for sanitary examination of cosmetic products in Ukraine:

  1.  Application.
  2. The list of products.
  3. Power of attorney or contract for representation of interests (from the manufacturer – if not manufacturer is registering and paying.)
  4. Registration certificate of the manufacturer (or manufacturing license).
  5. Certificates quality management system implementation in the production process (ISO 9001, GMP).
  6. Certificate of compliance with EU Directive 76/768 / EEC.
  7. Registration certificate of products in the country of origin and / or a certificate of free sale and a list of countries in which it is registered;
  8. Copy of the contract with the mandatory application of specifications (information about the complete product structure and performance of its identification), which is an integral part;
  9. Letter from the manufacturer that the product does not contain any components of the drug and genetically modified organisms.
  10. Quality: Composition (INCI), the specification of the finished product, quality certificates and / or analysis of the finished product.
  11. The safety and effectiveness: results of dermatological examination, toxicology reports, preclinical and clinical reports, scientific publications (these or other similar documents).
  12. Layout of package (including in electronic form – PDF or JPEG).
  13. While the sanitary-hygienic examination of several products – the catalog.
  14. Samples of the product.