CLINIGEN HEALTHCARE LIMITED – MIA(IMP) 31644
| Authorisation Number | UK MIA(IMP) 31644 |
| Category | MIA(IMP) |
| Holder | CLINIGEN HEALTHCARE LIMITED |
| Registered Address | CLINIGEN HEALTHCARE LIMITED, PITCAIRN HOUSE, CROWN SQUARE, FIRST AVENUE, BURTON-ON-TRENT, DE14 2WW, UNITED KINGDOM |
| Authorisation Date | Mar 03, 2026 |
| Legal Basis | InvestigationalPart 6 of The Medicines for Human Use (Clinical Trials) Regulations 2004 [SI 2004/1031] |
| Sites | 3 |
| Manufacturing Operations | 1.1 1.1.3 1.2 1.2.2 1.5 1.5.2 |
| Importation Operations | 2.2 2.2.1 2.2.1.1 2.2.1.2 2.2.2 2.2.3 2.2.3.1 2.2.3.2 2.2.3.3 2.2.3.4 2.2.3.5 2.2.3.6 2.3 2.3.1 2.3.4 |
| MHRA Link | View on MHRA Website |
Sites (3)
CLINIGEN HEALTHCARE LIMITED
BOTH
Country: UNITED KINGDOMProduct Class: Human Investigational Medicinal Products
Manufacturing
1.1 — Sterile Investigational Medicinal Products
1.1.3 — Batch certification
1.2 — Non-sterile investigational medicinal products
1.2.2 — Batch certification
1.5 — Packaging
1.5.2 — Secondary packaging
Importation
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
2.2.3 — Biological medicinal products
2.2.3.1 — Blood products
2.2.3.2 — Immunological products
2.2.3.3 — Cell therapy products
2.2.3.4 — Gene therapy products
2.2.3.5 — Biotechnology products
2.2.3.6 — Human or animal extracted products
2.3 — Other Importation Activities
2.3.1 — Site of Physical Importation
2.3.4 — Other
CLINIGEN HEALTHCARE LIMITED
BOTH
Country: UNITED KINGDOMProduct Class: Human Investigational Medicinal Products
Manufacturing
1.1 — Sterile Investigational Medicinal Products
1.1.3 — Batch certification
1.2 — Non-sterile investigational medicinal products
1.2.2 — Batch certification
Importation
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
CLINIGEN HEALTHCARE LIMITED
IMPORTATION_SITE
Country: UNITED KINGDOMProduct Class: Human Investigational Medicinal Products
Importation
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
2.2.3 — Biological medicinal products
2.2.3.2 — Immunological products
2.2.3.5 — Biotechnology products
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