Publications

  • Guidelines on Registration of Fixed Dose Combination Pharmaceutical Products, First Edition, January 2015. Download
  • Guidelines on Procedural Aspects for Application for Marketing Authorization for Human Medicinal Products, First Edition, January 2015. Download
  • Guidelines on List of Standard Terms for Medicinal Dosage Forms and Routes of Administration, First Edition, January 2015. Download
  • Guidelines on Format and Content of Summary of Product Characteristics for Medicinal Products,First Edition, January 2015. Download
  • Guidelines on Format and Content of Labels for Medicinal Products,First Edition, January 2015. Download