Medicines Guidelines

  • GMP Guidelines for VET Medicinal Products Download
  • Guidelines on Variations on Registered Medicinal Products Download
  • Guidelines on Submission of Documentation For Marketing Authorization of Human Vaccines, March 2020. Download
  • Guidelines on Submission of Documentation for Marketing Authorization of Biotherapeutics Products, March 2020. Download
  • Guidelines on Submission of Documentation For Marketing Authorization of Similar Biotherapeutics Products, March 2020. Download
  • Compendium of Medicines Evaluation and Registration for Medicines Regulation Harmonization for EAC, September 2014. Download