Patern Ltd

Standard Regulatory Quality

Structure of the dossier for cosmetic products

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  • Power of Attorney for registration.
  • Certificate of registration of the manufacturer (or manufacturing license).
  • Certificate regarding implementation of the quality management system (for example – ISO 9001, GMP etc.).
  • Certificate of compliance to directive of the EU 76/768/ EEC.
  • Certificate of State registration of the product in manufacturer's country and/or free sales certificate.
  • Official letter from manufacturer that product does not include active medical substances and GMO.
  • Quality: composition, specification of the finished product, certificate of quality and/or analysis.
  • Safety and efficiency: results of dermatology studies, toxicological reports, preclinical and clinical reports, scientific publications (or similar documents).
  • Artworks of package design (in PDF or JPEG as well).
  • In a case submitting dossier for several products – catalogue.
  • Samples of the product.


 

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tuv

We are an ISO 9001:2008 certified company

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ACC

Our company is a member oа American Chamber of Commerce