Medicines and Healthcare products Regulatory Agency
| 1: Authorisation Number | UK MIA(IMP) 17328 |
|---|---|
| 2: Name of authorisation holder | GREAT ORMOND STREET HOSPITAL FOR CHILDREN NHS FOUNDATION TRUST |
| 3: Address(es) of manufacturing site(s) |
ZAYED CENTRE FOR RESEARCH INTO RARE DISEASE IN CHILDREN, 20 GUILFORD STREET, LONDON, WC1N 1DZ, UNITED KINGDOM GREAT ORMOND STREET HOSPITAL FOR CHILDREN NHS FOUNDATION TRUST, GENE AND CELL THERAPY, GREAT ORMOND STREET, LONDON, WC1N 3JH, UNITED KINGDOM |
| 4: Legally registered address of authorisation holder | GREAT ORMOND STREET HOSPITAL FOR CHILDREN NHS FOUNDATION TRUST, GREAT ORMOND STREET, LONDON, WC1N 3JH, UNITED KINGDOM |
| 5: Scope of authorisation and dosage forms | ANNEX 1 and/ or ANNEX 2 |
| 6: Legal Basis of authorisation | |
| 7: Name of responsible officer of the competent authority of the member state granting the manufacturing authorisation | Confidential |
| 8: Authorisation Date | 11/10/2024 |
| 9: Annexes attached | Annex 1 and/or Annex 2 |
SCOPE OF AUTHORISATION
Annex 2
Name and address of the site:
ZAYED CENTRE FOR RESEARCH INTO RARE DISEASE IN CHILDREN, 20 GUILFORD STREET, LONDON, WC1N 1DZ, UNITED KINGDOM
Human Investigational Medicinal Products
| Authorised Operations |
| MANUFACTURING OPERATIONS (according to part 1)IMPORTATION OF MEDICINAL PRODUCTS (according to part 2) |
| Part 1 - MANUFACTURING OPERATIONS |
| [ 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 Special Requirements Viral vectors |
| [ 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 Special Requirements Viral vectors |
| [ 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 |
| Part 2 - IMPORTATION OF MEDICINAL PRODUCTS |
| [ 2.3 ] Other Importation Activities |
| [ 2.3.2 ] Importation of Intermediate which undergoes further processing |
| [ 2.3.4 ] Other Importation of QP-certified IMPs from a country on the approved country for import list |
SCOPE OF AUTHORISATION
Annex 2
Name and address of the site:
GREAT ORMOND STREET HOSPITAL FOR CHILDREN NHS FOUNDATION TRUST, GENE AND CELL THERAPY, GREAT ORMOND STREET, LONDON, WC1N 3JH, UNITED KINGDOM
Human Investigational Medicinal Products
| Authorised Operations |
| MANUFACTURING OPERATIONS (according to part 1)IMPORTATION OF MEDICINAL PRODUCTS (according to part 2) |
| Part 1 - MANUFACTURING OPERATIONS |
| [ 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 |
| Part 2 - IMPORTATION OF MEDICINAL PRODUCTS |
| [ 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 Importation of QP-certified IMPs from a country on the approved country for import list |