Medicines and Healthcare products Regulatory Agency
| 1: Authorisation Number | UK MIA 45366 |
|---|---|
| 2: Name of authorisation holder | SIEMENS HEALTHCARE LIMITED |
| 3: Address(es) of manufacturing site(s) |
PETNET SOLUTIONS (SIEMENS HEALTHCARE LIMITED), NOTTINGHAM CITY HOSPITAL, GATE 1, HUCKNALL ROAD, NOTTINGHAM, NG5 1PB, UNITED KINGDOM PETNET SOLUTIONS (SIEMENS HEALTHCARE LIMITED), LESLEY HARRISON BUILDING, MOUNT VERNON HOSPITAL, NORTHWOOD, HA6 2RN, UNITED KINGDOM |
| 4: Legally registered address of authorisation holder | SIEMENS HEALTHCARE LIMITED, PARK VIEW, WATCHMOOR PARK, RIVERSIDE WAY, CAMBERLEY, GU15 3YL, 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 | 04/03/2024 |
| 9: Annexes attached | Annex 1 and/or Annex 2 |
SCOPE OF AUTHORISATION
Annex 1
Name and address of the site:
PETNET SOLUTIONS (SIEMENS HEALTHCARE LIMITED), NOTTINGHAM CITY HOSPITAL, GATE 1, HUCKNALL ROAD, NOTTINGHAM, NG5 1PB, UNITED KINGDOM
Human Medicinal Products
| Authorised Operations |
| MANUFACTURING OPERATIONS (according to part 1) |
| Part 1 - MANUFACTURING OPERATIONS |
| [ 1.1 ] Sterile 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 Positron Emission Radiopharmaceuticals for injection |
| [ 1.4 ] Other products or manufacturing activity |
| [ 1.4.2 ] Sterilisation of active substances/excipients/finished products: |
| [ 1.4.2.1 ] Filtration |
| [ 1.6 ] Quality control testing |
| [ 1.6.2 ] Microbiological: non-sterility |
| [ 1.6.3 ] Chemical/Physical |
SCOPE OF AUTHORISATION
Annex 1
Name and address of the site:
PETNET SOLUTIONS (SIEMENS HEALTHCARE LIMITED), LESLEY HARRISON BUILDING, MOUNT VERNON HOSPITAL, NORTHWOOD, HA6 2RN, UNITED KINGDOM
Human Medicinal Products
| Authorised Operations |
| MANUFACTURING OPERATIONS (according to part 1) |
| Part 1 - MANUFACTURING OPERATIONS |
| [ 1.1 ] Sterile 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 Positron Emission Radiopharmaceuticals for injection. |
| [ 1.4 ] Other products or manufacturing activity |
| [ 1.4.2 ] Sterilisation of active substances/excipients/finished products: |
| [ 1.4.2.1 ] Filtration |
| [ 1.5 ] Packaging |
| [ 1.5.2 ] Secondary packaging |
| [ 1.6 ] Quality control testing |
| [ 1.6.2 ] Microbiological: non-sterility |
| [ 1.6.3 ] Chemical/Physical |