Medicines and Healthcare products Regulatory Agency
| 1: Authorisation Number | UK MIA(IMP) 24816 |
|---|---|
| 2: Name of authorisation holder | IMMUNOCLIN LIMITED |
| 3: Address(es) of manufacturing site(s) |
IMMUNOCLIN LIMITED, C/O MEDICAL TECHNOLOGIES INNOVATION FACILITY (MTIF), CLIFTON CAMPUS, NOTTINGHAM TRENT UNIVERSITY, CLIFTON LANE, NOTTINGHAM, NG11 8NS, UNITED KINGDOM |
| 4: Legally registered address of authorisation holder | IMMUNOCLIN LIMITED, C/O MEDICAL TECHNOLOGIES INNOVATION FACILITY (MTIF), CLIFTON CAMPUS, NOTTINGHAM TRENT UNIVERSITY, CLIFTON LANE, NOTTINGHAM, NG11 8NS, 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 | 14/03/2025 |
| 9: Annexes attached | Annex 1 and/or Annex 2 |
SCOPE OF AUTHORISATION
Annex 2
Name and address of the site:
IMMUNOCLIN LIMITED, C/O MEDICAL TECHNOLOGIES INNOVATION FACILITY (MTIF), CLIFTON CAMPUS, NOTTINGHAM TRENT UNIVERSITY, CLIFTON LANE, NOTTINGHAM, NG11 8NS, UNITED KINGDOM
Human Investigational Medicinal Products
| Authorised Operations |
| MANUFACTURING OPERATIONS (according to part 1) |
| Part 1 - MANUFACTURING OPERATIONS |
| [ 1.1 ] Sterile Investigational Medicinal Products |
| [ 1.1.3 ] Batch certification |
| [ 1.3 ] Biological investigational medicinal products |
| [ 1.3.1 ] Biological medicinal products |
| [ 1.3.1.6 ] Human or animal extracted products Special Requirements Manufacture of biological drug substance and bulk drug product from snake venom |
| [ 1.3.2 ] Batch certification |
| [ 1.3.2.6 ] Human or animal extracted products Special Requirements Manufacture of biological drug substance and bulk drug product from snake venom |
| [ 1.4 ] Other investigational medicinal products or manufacturing activitiy |
| [ 1.4.1 ] Manufacture of: |
| [ 1.4.1.2 ] Homoeopathic products |
| [ 1.5 ] Packaging |
| [ 1.5.2 ] Secondary packaging |
| [ 1.6 ] Quality control testing |
| [ 1.6.3 ] Chemical/Physical |
| [ 1.6.4 ] Biological |