What are the main requirements for a health approval concerning medicines (simple homeopathic)

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  • Certificate of the incorporation, existence and legal representation of the requesting entity and the importer and conditioner, if applicable.
  • Certificate of the valid Good Manufacture Practices.
  • Certificate issued by the Health Authority which stipulates that the use of the product has been authorized within the territory of the country of origin indicating the name of the product, pharmaceutical formula and composition.
  • Explicit authorization granted by the holder to the importer to apply for the health registration in his name and/or commercialize the product, according to the case.
  • Manufacturing contract when the product is packaged or conditioned by third parties.
  • Copy of the registrations of production and control (history of the batch) corresponding with a least two piles.
  • If the product contains substances which may be considered as risk factors for the transmission of bovine spongiform encephalopathy and originates from another country than Colombia, there needs to be supporting documentation included that certifies that the said ingredient is free from prions causing bovine spongiform encephalopathy.
  • Scientific nomination or other nomination of the homeopathic variety of mother tinctures in one of the officially accepted pharmacopoeias.
  • Group of the dilutions which constitute the product.
  • Pharmaceutical form and commercial presentations, specifying the type and material of the container and/or packaging.
  • Quali-quantitative composition of the product.
  • Procedure of the obtaining and certificate of the quality control of the homeopathic variety or mother tinctures or shredding or dilution base indicating the homeopathic rule, name and edition of the pharmacopoeias officially accepted in Colombia which are used.
  • Specifications and results of the quality control of the auxiliaries of the formula including the method of dilution, scale of dynamization and the pharmaceutical pharmacopoeias officially used.
  • Information about the stability of the medicine.
  • Draft of the final bottle and/or packaging (in color).
  • Information about the route of administration, contraindications and precautions.
  • Letter of the technical director, pharmaceutical chemist, underwriting the technical information mentioned above.