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CHILE |
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Authority |
ministerio de salud Inistitute de salud publicode chile |
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website |
www.minisal.cl/ , http://www.ispch.cl/ |
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if any |
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DOSSIER REQUIRMENTS |
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S.No |
CONTENT OF THE COMMON PARTS |
Page No. |
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1. |
Quali – Quantitative formulation complete in weight / volume units or in conventional units internationally recognized. --------------------------------------- |
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2. |
Quality and purity specifications of raw materials, including bibliographic references (Pharmacopoeia, number of page or another specific reference) If there are not known bibliographic references as USP, BP, Ph, Eur the corresponding monography of the row material must be included.----------------- |
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3. |
Properties of the active ingredient. Additionally is necessary the IR Spectrum or UV or Chromatograms. Moreover, the packaging and storage conditions. --------------------------------------------------------------------------------------------------- |
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4. |
Details of the supplier of active ingredients. ----------------------------------------- |
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5. |
Primary Standard of the active ingredient (WS), with COA.----------------------- |
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6. |
Finished Product specifications. If the formula include pigments they must be identificated. Additionally must be attached the COA with IR spectrum or UV or Chromatograms of standard and active ingredient.------------------------------- |
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7. |
Analytical Method for the finished product. ------------------------------------------ |
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8. |
Stability data confirming the proposed efficiency period. (three lots)------------- |
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9. |
Sterility, microbiology and toxicity assay. -------------------------------------------- |
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10. |
Draft of product label for primary and secondary packages of all the sales presentation, clinical packages and samples. ----------------------------------------- |
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11. |
Packages description including all components and materials used for this purpose. ----------------------------------------------------------------------------------- |
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12. |
Product presentations, describing the contents of the different packages for sales presentation, clinical package and samples. ----------------------------------- |
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13. |
Finished product sample with COA ( sufficient quantity to complete 4 analysis) ----------------------------------------------------------------------------------- |
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14. |
Clinical – Pharmacologic Monography ---------------------------------------------- |
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15. |
Drafts “Information for the healthcare professionals”. ---------------------------- |
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16. |
Draft “Advice for the patients”. ----------------------------------------------------- |
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17. |
Scientific information. --------------------------------------------------------------- |
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18. |
Bibliographic references. ------------------------------------------------------------ |
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19. |
Legal documents ---------------------------------------------------------------------- |
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19.1 |
Power of Attorney. ----------------------------------------------------------- |
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19.2 |
Free sales certificate in the origin containing the complete quali - quantitative formula. ------------------------------------------------------- |
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19.3 |
WHO or FDA GMP certificate of the manufacturing plant granted by the health authority in the origin. -------------------------------------- |
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19.4 |
Trade mark certificate. ------------------------------------------------------ |
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Toc for chile, toc formate for dossier
