TORBAY PHARMACEUTICALS LIMITED – MIA(IMP) 56021

1.1 — Sterile Investigational Medicinal Products

1.1.2 — Terminally Sterilised (processing operations for the following dosage forms)

1.1.2.1 — Large volume liquids

1.1.2.3 — Small volume liquids

1.1.3 — Batch certification

1.2 — Non-sterile investigational medicinal products

1.2.1 — Non-Sterile Products (processing operations for the following dosage forms)

1.2.1.5 — Liquids for external use

1.2.1.6 — Liquids for internal use

1.2.1.11 — Semi-solids

1.2.2 — Batch certification

1.4 — Other investigational medicinal products or manufacturing activitiy

1.4.1 — Manufacture of:

1.4.1.1 — Herbal products

1.4.2 — Sterilisation of active substances/excipients/finished products:

1.4.2.3 — Moist heat

1.5 — Packaging

1.5.1 — Primary packaging

1.5.1.5 — Liquids for external use

1.5.1.6 — Liquids for internal use

1.5.1.11 — Semi-solids

1.6 — Quality control testing

1.6.1 — Microbiological: sterility

1.6.2 — Microbiological: non-sterility

1.6.3 — Chemical/Physical

2.1 — Quality control testing of imported medicinal products

2.1.1 — Microbiological: sterility

2.1.2 — Microbiological: non-sterility

2.1.3 — Chemical/Physical

2.2 — Batch certification of imported medicinal products

2.2.1 — Sterile Products

2.2.1.1 — Aseptically prepared

2.2.1.2 — Terminally sterilised

2.2.2 — Non-sterile products

2.3 — Other Importation Activities

2.3.4 — Other