GREAT ORMOND STREET HOSPITAL FOR CHILDREN NHS FOUNDATION TRUST – MIA(IMP) 17328
| Authorisation Number | UK MIA(IMP) 17328 |
| Category | MIA(IMP) |
| Holder | GREAT ORMOND STREET HOSPITAL FOR CHILDREN NHS FOUNDATION TRUST |
| Registered Address | GREAT ORMOND STREET HOSPITAL FOR CHILDREN NHS FOUNDATION TRUST, GREAT ORMOND STREET, LONDON, WC1N 3JH, UNITED KINGDOM |
| Authorisation Date | Feb 03, 2026 |
| Legal Basis | InvestigationalPart 6 of The Medicines for Human Use (Clinical Trials) Regulations 2004 [SI 2004/1031] |
| Sites | 2 |
| Manufacturing Operations | 1.1 1.1.1 1.1.1.4 1.1.3 1.3 1.3.1 1.3.1.3 1.3.1.4 1.3.1.5 1.3.2 1.3.2.3 1.3.2.4 1.3.2.5 1.4 1.4.2 1.4.2.1 1.5 1.5.2 1.6 1.6.2 |
| Importation Operations | 1.1 1.1.1 1.1.1.4 1.1.3 1.3 1.3.1 1.3.1.3 1.3.1.4 1.3.2 1.3.2.3 1.3.2.4 1.5 1.5.2 1.6 1.6.2 2.3 2.3.2 2.3.4 |
| MHRA Link | View on MHRA Website |
Sites (2)
GREAT ORMOND STREET HOSPITAL FOR CHILDREN NHS FOUNDATION TRUST
BOTH
Country: UNITED KINGDOMProduct Class: Human Investigational Medicinal Products
Manufacturing
1.1 — Sterile Investigational Medicinal Products
1.1.1 — Aseptically prepared (processing operations for the following dosage forms)
1.1.1.4 — Small volume liquids
1.1.3 — Batch certification
1.3 — Biological investigational medicinal products
1.3.1 — Biological medicinal products
1.3.1.3 — Cell therapy products
1.3.1.4 — Gene therapy products
1.3.2 — Batch certification
1.3.2.3 — Cell therapy products
1.3.2.4 — Gene therapy products
1.5 — Packaging
1.5.2 — Secondary packaging
1.6 — Quality control testing
1.6.2 — Microbiological: non-sterility
Importation
1.1 — Sterile Investigational Medicinal Products
1.1.1 — Aseptically prepared (processing operations for the following dosage forms)
1.1.1.4 — Small volume liquids
1.1.3 — Batch certification
1.3 — Biological investigational medicinal products
1.3.1 — Biological medicinal products
1.3.1.3 — Cell therapy products
1.3.1.4 — Gene therapy products
1.3.2 — Batch certification
1.3.2.3 — Cell therapy products
1.3.2.4 — Gene therapy products
1.5 — Packaging
1.5.2 — Secondary packaging
1.6 — Quality control testing
1.6.2 — Microbiological: non-sterility
2.3 — Other Importation Activities
2.3.4 — Other
ZAYED CENTRE FOR RESEARCH INTO RARE DISEASE IN CHILDREN
BOTH
Country: UNITED KINGDOMProduct Class: Human Investigational Medicinal Products
Manufacturing
1.1 — Sterile Investigational Medicinal Products
1.1.1 — Aseptically prepared (processing operations for the following dosage forms)
1.1.1.4 — Small volume liquids
1.1.3 — Batch certification
1.3 — Biological investigational medicinal products
1.3.1 — Biological medicinal products
1.3.1.3 — Cell therapy products
1.3.1.4 — Gene therapy products
1.3.1.5 — Biotechnology products
1.3.2 — Batch certification
1.3.2.3 — Cell therapy products
1.3.2.4 — Gene therapy products
1.3.2.5 — Biotechnology products
1.4 — Other investigational medicinal products or manufacturing activitiy
1.4.2 — Sterilisation of active substances/excipients/finished products:
1.4.2.1 — Filtration
1.5 — Packaging
1.5.2 — Secondary packaging
Importation
2.3 — Other Importation Activities
2.3.2 — Importation of Intermediate which undergoes further processing
2.3.4 — Other
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