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Registration Product License of Narcotics Substances

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23

Description

Products required having license

  • Narcotic drug schedule 3
  • Psychotropic substance schedule 3 and 4

Provision Cost

  • Government Fee (new drugs) 736,000
  • Government Fee (generic drugs) 41,000
  • Remark: The exact government fee will be known after submit to Thai FDA due to the chemical substance that combines in drugs.

Procedure and Timeline

  • We will provide the application form that needed to be filled.
  • We will submit to Thai FDA.
  • We need to keep close communication during that time in case the additional charge may occur or additional documents may require.
  • **It will take around 167 working days for new drug registration and 130 working days for generic drugs registration.**

Required Documents

  • A copy of license to manufacture or import the narcotics of category 3 and psychotropic substance 3 or 4.
  • In case that the sell representative is available; a copy of license to sell the narcotics of category 3 and psychotropic substance 3 or 4 is also required.
  • Certificate of Pharmaceutical Product or Certificate of Free Sale is required for the import product.
  • Good Manufacturing Practices (GMP) certificate.
  • Photograph of the pharmaceutical product(s).
  • Drafts of the labels and patient information leaflets.
  • The formulation of one unit.
  • The complete batch manufacturing master formula.
  • Method of manufacture.
  • In-process specification and the control method.
  • Raw material specification and the control method.
  • Certificate of analysis of the raw material of the active ingredient.
  • Analytical data and the chromatogram or spectrum of the raw material of the active ingredient.
  • Finished product specification and the control method.
  • Certificate of analysis of the finished product.
  • Analytical data and the chromatogram or spectrum of the finished product.
  • Packaging, labeling and storage.
  • Method validation, in the case that the analysis methods used does not conform to the one(s) in the official pharmacopoeias.
  • Data from the stability study.
  • Drug sample.

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Listing ID: 8435b693eab0f0fb

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