Medicines Guidelines

  • Guidelines for Submission of Documentation For Marketing Authorization of Biocidal (Antiseptic and Disinfectant) Products Download
  • Guideline on Submission of Documentation for Marketing Authorization of Herbal Medicinal Products_1 Download
  • Guidelines for Registration of Herbal Medicines Download
  • Guidelines for Control of Promotion and Advertisement of Medicines, Medical Devices and Cosmetics in Tanzania, 2015 Download
  • Guidelines on Format and Content of Labels for Medicinal Products Download
  • Guidelines on Format and Content of Patient Information Leaflet for Medicinal Products Download
  • Guidelines on Format and Content of Summary of Product Characteristics for Medicinal Products Download
  • Guidelines on List of Standard Terms for Medicinal Dosage Forms and Routes of Administration Download
  • Guidelines on Procedural Aspects for Application for Marketing Authorization for Human Medicinal Products Download
  • Guidelines on Registration of Fixed Dose Combination Pharmaceutical Products Download
  • Guidelines on Stability Testing Requirements for APIs and FPPs Download
  • Guidelines on Submission of Documentation for Registration of Medicines Download
  • Guidelines on Therapeutic Equivalence Requirements Download
  • GMP EAC Compendium Download