Medicines and Healthcare products Regulatory Agency
| 1: Authorisation Number | UK MIA(IMP) 21761 |
|---|---|
| 2: Name of authorisation holder | UNIVERSITY OF BIRMINGHAM |
| 3: Address(es) of manufacturing site(s) |
UNIVERSITY OF BIRMINGHAM, CELL THERAPY FACILITY, ADVANCED THERAPIES FACILITY, WOLFSON DRIVE, EDGBASTON, BIRMINGHAM, B15 2TT, UNITED KINGDOM |
| 4: Legally registered address of authorisation holder | UNIVERSITY OF BIRMINGHAM, CELL THERAPY FACILITY, ADVANCED THERAPIES FACILITY, WOLFSON DRIVE, EDGBASTON, BIRMINGHAM, B15 2TT, 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 | 26/10/2023 |
| 9: Annexes attached | Annex 1 and/or Annex 2 |
SCOPE OF AUTHORISATION
Annex 2
Name and address of the site:
UNIVERSITY OF BIRMINGHAM, CELL THERAPY FACILITY, ADVANCED THERAPIES FACILITY, WOLFSON DRIVE, EDGBASTON, BIRMINGHAM, B15 2TT, UNITED KINGDOM
Human Investigational Medicinal Products
| Authorised Operations |
| MANUFACTURING OPERATIONS (according to part 1) |
| 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 |
| [ 1.3 ] Biological investigational medicinal products |
| [ 1.3.1 ] Biological medicinal products |
| [ 1.3.1.1 ] Blood products |
| [ 1.3.1.3 ] Cell therapy products |
| [ 1.3.1.6 ] Human or animal extracted products |
| [ 1.3.1.7 ] Tissue Engineered Products |
| [ 1.3.1.8 ] Other biological medicinal products Faecal microbiome |
| [ 1.3.2 ] Batch certification |
| [ 1.3.2.1 ] Blood products |
| [ 1.3.2.3 ] Cell therapy products |
| [ 1.3.2.6 ] Human or animal extracted products |
| [ 1.3.2.7 ] Tissue Engineered Products |
| [ 1.3.2.8 ] Other biological medicinal products Faecal microbiome |
| [ 1.4 ] Other investigational medicinal products or manufacturing activitiy |
| [ 1.4.1 ] Manufacture of: |
| [ 1.4.1.3 ] Other Extraction of faecal microbiome from human faeces |
| [ 1.5 ] Packaging |
| [ 1.5.2 ] Secondary packaging |
| [ 1.6 ] Quality control testing |
| [ 1.6.4 ] Biological |