Medicines and Healthcare products Regulatory Agency
| 1: Authorisation Number | UK MIA(IMP) 14620 |
|---|---|
| 2: Name of authorisation holder | BARTS HEALTH NHS TRUST |
| 3: Address(es) of manufacturing site(s) |
BARTS HEALTH NHS TRUST (NUCLEAR MEDICINE RADIOPHARMACY UNIT BASEMENT), NUCLEAR MEDICINE- RADIOPHARMACY, BASEMENT, KING GEORGE V WING, ST BARTHOLOMEW'S HOSPITAL, WEST SMITHFIELD, LONDON, EC1A 7BE, UNITED KINGDOM BARTS HEALTH NHS TRUST (PHARMACY CHEMOTHERAPY UNIT 7TH FLOOR), DEPARTMENT OF PHARMACY- PHARMACY CHEMOTHERAPY UNIT, 7TH FLOOR, KING GEORGE V WING, ST BARTHOLOMEW'S HOSPITAL, WEST SMITHFIELD, LONDON, EC1A 7BE, UNITED KINGDOM BARTS HEALTH NHS TRUST, PHARMACY TECHNICAL SERVICES, 1ST FLOOR PATHOLOGY & PHARMACY BUILDING, ROYAL LONDON HOSPITAL ,80 NEWARK STREET, LONDON, E1 2ES, UNITED KINGDOM |
| 4: Legally registered address of authorisation holder | BARTS HEALTH NHS TRUST, 80 NEWARK STREET, WHITECHAPEL, LONDON, E1 2ES, 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 | 01/07/2024 |
| 9: Annexes attached | Annex 1 and/or Annex 2 |
BARTS HEALTH NHS TRUST (NUCLEAR MEDICINE RADIOPHARMACY UNIT BASEMENT), NUCLEAR MEDICINE- RADIOPHARMACY, BASEMENT, KING GEORGE V WING, ST BARTHOLOMEW'S HOSPITAL, WEST SMITHFIELD, LONDON, EC1A 7BE, UNITED KINGDOM
| 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 |
| [ 1.1.1.6 ] Other aseptically prepared products Radiopharmaceuticals / Radionuclide Generators/ IMP product dispensing, large and small volumes diagnostic purposes |
| [ 1.1.3 ] Batch certification |
| [ 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 |
| [ 1.5.1 ] Primary packaging |
| [ 1.5.1.10 ] Radionuclide generators |
| [ 1.6 ] Quality control testing |
| [ 1.6.1 ] Microbiological: sterility |
BARTS HEALTH NHS TRUST (PHARMACY CHEMOTHERAPY UNIT 7TH FLOOR), DEPARTMENT OF PHARMACY- PHARMACY CHEMOTHERAPY UNIT, 7TH FLOOR, KING GEORGE V WING, ST BARTHOLOMEW'S HOSPITAL, WEST SMITHFIELD, LONDON, EC1A 7BE, UNITED KINGDOM
| 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) |
| [ 1.1.1.1 ] Large volume liquids |
| [ 1.1.2 ] Terminally Sterilised (processing operations for the following dosage forms) |
| [ 1.1.2.1 ] Large volume liquids |
| [ 1.2 ] Non-sterile investigational medicinal products |
| [ 1.2.1 ] Non-Sterile Products (processing operations for the following dosage forms) |
| [ 1.2.1.5 ] Liquids for external use |
| [ 1.2.1.6 ] Liquids for internal use |
| [ 1.3 ] Biological investigational medicinal products |
| [ 1.3.1 ] Biological medicinal products |
| [ 1.3.1.4 ] Gene therapy products |
| [ 1.3.1.8 ] Other biological medicinal products Monoclonal Antibodies |
| [ 1.4 ] Other investigational medicinal products or manufacturing activitiy |
| [ 1.4.1 ] Manufacture of: |
| [ 1.4.1.3 ] Other Radiopharmaceuticals/radionuclide generators |
| [ 1.5 ] Packaging |
| [ 1.5.1 ] Primary packaging |
| [ 1.5.1.5 ] Liquids for external use |
| [ 1.5.1.6 ] Liquids for internal use |
| [ 1.5.1.11 ] Semi-solids |
| [ 1.5.2 ] Secondary packaging |
| [ 1.6 ] Quality control testing |
| [ 1.6.2 ] Microbiological: non-sterility |
| [ 1.6.3 ] Chemical/Physical |
BARTS HEALTH NHS TRUST, PHARMACY TECHNICAL SERVICES, 1ST FLOOR PATHOLOGY & PHARMACY BUILDING, ROYAL LONDON HOSPITAL ,80 NEWARK STREET, LONDON, E1 2ES, UNITED KINGDOM
| 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) |
| [ 1.1.1.1 ] Large volume liquids |
| [ 1.1.1.4 ] Small volume liquids |
| [ 1.2 ] Non-sterile investigational medicinal products |
| [ 1.2.1 ] Non-Sterile Products (processing operations for the following dosage forms) |
| [ 1.2.1.5 ] Liquids for external use |
| [ 1.2.1.6 ] Liquids for internal use |
| [ 1.2.1.11 ] Semi-solids |
| [ 1.3 ] Biological investigational medicinal products |
| [ 1.3.1 ] Biological medicinal products |
| [ 1.3.1.4 ] Gene therapy products |
| [ 1.3.1.8 ] Other biological medicinal products Antibodies/antibody conjugates |
| [ 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 |
| [ 1.5.1 ] Primary packaging |
| [ 1.5.1.13 ] Tablets |
| [ 1.5.2 ] Secondary packaging |
| [ 1.6 ] Quality control testing |
| [ 1.6.2 ] Microbiological: non-sterility |
| [ 1.6.3 ] Chemical/Physical |