Forms – Establishment licences – Drugs and health products

Drugs

• Drug Establishment Licence Application Forms and Instructions (FRM-0033)
  [2014-10-23]
  • Table A: Foreign Building Conducting Active Pharmaceutical Ingredients Related Licensable Activities

Medical Device

• Medical Device Establishment Licence (MDEL) application: instructions (FRM-0292) [2020-04-01]

Blood

• Blood Establishment Registration Application: Form and Instructions - (FRM-0353)
• Blood Establishment Licensing Application Form and Instructions - (FRM-0354)

Human Cells, Tissues and Organs

• Human Cells, Tissues and Organs (CTO) for Transplantation Registration Application Form (FRM-0171)
• Human Cells, Tissues and Organs for Transplantation - Error or Accident Prelimanary Investigation Report Form (FRM-0172)