Medicines Registration Guidelines

  • National Guidelines for Monitoring Medicines Safety, 2010.
  • Guidelines on Submission of Documentation for Registration of Human Pharmaceutical Products, 2015.
  • Guidelines for Application for Registration of Biologicals, 2004.
  • Application Guidelines for Variation of Registered Human Medicinal Products, 2008.
  • Application Guidelines for Registration of Veterinary Medicinal Products, 2016.
  • Guidelines for on submission of documentation for registration of immunological veterinary products, 2017