Medicines and Healthcare products Regulatory Agency
| 1: Authorisation Number | UK MIA(IMP) 31644 |
|---|---|
| 2: Name of authorisation holder | CLINIGEN HEALTHCARE LIMITED |
| 3: Address(es) of manufacturing site(s) |
CLINIGEN HEALTHCARE LIMITED, UNIT 3, CANADA ROAD, BYFLEET, WEST BYFLEET, KT14 7JL, UNITED KINGDOM CLINIGEN HEALTHCARE LIMITED, IDIS HOUSE, CHURCHFIELD ROAD, WEYBRIDGE, KT13 8DB, UNITED KINGDOM CLINIGEN HEALTHCARE LIMITED, PITCAIRN HOUSE, CROWN SQUARE, FIRST AVENUE, BURTON-ON-TRENT, DE14 2WW, UNITED KINGDOM |
| 4: Legally registered address of authorisation holder | CLINIGEN HEALTHCARE LIMITED, PITCAIRN HOUSE, CROWN SQUARE, FIRST AVENUE, BURTON-ON-TRENT, DE14 2WW, 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 | 03/03/2026 |
| 9: Annexes attached | Annex 1 and/or Annex 2 |
CLINIGEN HEALTHCARE LIMITED, UNIT 3, CANADA ROAD, BYFLEET, WEST BYFLEET, KT14 7JL, UNITED KINGDOM
| 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 |
| [ 1.1.3 ] Batch certification |
| [ 1.2 ] Non-sterile investigational medicinal products |
| [ 1.2.2 ] Batch certification |
| [ 1.5 ] Packaging |
| [ 1.5.2 ] Secondary packaging |
| Part 2 - IMPORTATION OF MEDICINAL PRODUCTS |
| [ 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 Importation of QP certified IMPs from a country on the 'approved country for import list'. |
CLINIGEN HEALTHCARE LIMITED, IDIS HOUSE, CHURCHFIELD ROAD, WEYBRIDGE, KT13 8DB, UNITED KINGDOM
| 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 |
| [ 1.1.3 ] Batch certification |
| [ 1.2 ] Non-sterile investigational medicinal products |
| [ 1.2.2 ] Batch certification |
| Part 2 - IMPORTATION OF MEDICINAL PRODUCTS |
| [ 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, PITCAIRN HOUSE, CROWN SQUARE, FIRST AVENUE, BURTON-ON-TRENT, DE14 2WW, UNITED KINGDOM
| Authorised Operations |
| IMPORTATION OF MEDICINAL PRODUCTS (according to part 2) |
| Part 2 - IMPORTATION OF MEDICINAL PRODUCTS |
| [ 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 |