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 UNIVERSITY OF BIRMINGHAM, MICROBIOME TREATMENT CENTRE, VINCENT 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 | 19/03/2025 |
| 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 |
| [ 1.5 ] Packaging |
| [ 1.5.2 ] Secondary packaging |
SCOPE OF AUTHORISATION
Annex 2
Name and address of the site:
UNIVERSITY OF BIRMINGHAM, MICROBIOME TREATMENT CENTRE, VINCENT DRIVE, EDGBASTON, BIRMINGHAM, B15 2TT, UNITED KINGDOM
Human Investigational Medicinal Products
| Authorised Operations |
| MANUFACTURING OPERATIONS (according to part 1) |
| Part 1 - MANUFACTURING OPERATIONS |
| [ 1.3 ] Biological investigational medicinal products |
| [ 1.3.1 ] Biological medicinal products |
| [ 1.3.1.8 ] Other biological medicinal products Faecal Microbiome |
| [ 1.3.2 ] Batch certification |
| [ 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 Storage of products in cryobags and cryiovials. Extraction of faecal microbiome from human faeces |
| [ 1.5 ] Packaging |
| [ 1.5.2 ] Secondary packaging |