Medicines and Healthcare products Regulatory Agency
| 1: Authorisation Number | UK MIA(IMP) 29724 |
|---|---|
| 2: Name of authorisation holder | ACADEMIC UNIT OF RADIOLOGY UNIVERSITY OF SHEFFIELD |
| 3: Address(es) of manufacturing site(s) |
UNIVERSITY OF SHEFFIELD, ACADEMIC UNIT OF RADIOLOGY, C FLOOR, DIVISION OF CLINICAL SCIENCES, ROYAL HALLAMSHIRE HOSPITAL, GLOSSOP ROAD, SHEFFIELD, S10 2JF, UNITED KINGDOM NORTHERN GENERAL HOSPITAL, XENON POLARISER LABORATORY,CLINICAL RESEARCH FACILITY, NORTHERN GENERAL HOSPITAL, HERRIES ROAD, SHEFFIELD, S5 7AU, UNITED KINGDOM |
| 4: Legally registered address of authorisation holder | ACADEMIC UNIT OF RADIOLOGY UNIVERSITY OF SHEFFIELD, ACADEMIC UNIT OF RADIOLOGY, C FLOOR, DIVISION OF CLINICAL SCIENCES, ROYAL HALLAMSHIRE HOSPITAL, GLOSSOP ROAD, SHEFFIELD, S10 2JF, 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 | 25/06/2019 |
| 9: Annexes attached | Annex 1 and/or Annex 2 |
UNIVERSITY OF SHEFFIELD, ACADEMIC UNIT OF RADIOLOGY, C FLOOR, DIVISION OF CLINICAL SCIENCES, ROYAL HALLAMSHIRE HOSPITAL, GLOSSOP ROAD, SHEFFIELD, S10 2JF, UNITED KINGDOM
| Authorised Operations |
| MANUFACTURING OPERATIONS (according to part 1) |
| Part 1 - MANUFACTURING OPERATIONS |
| [ 1.4 ] Other investigational medicinal products or manufacturing activitiy |
| [ 1.4.1 ] Manufacture of: |
| [ 1.4.1.3 ] Other Polarisation of inert medicinal gasses. |
| [ 1.6 ] Quality control testing |
| [ 1.6.3 ] Chemical/Physical |
NORTHERN GENERAL HOSPITAL, XENON POLARISER LABORATORY,CLINICAL RESEARCH FACILITY, NORTHERN GENERAL HOSPITAL, HERRIES ROAD, SHEFFIELD, S5 7AU, UNITED KINGDOM
| Authorised Operations |
| MANUFACTURING OPERATIONS (according to part 1) |
| Part 1 - MANUFACTURING OPERATIONS |
| [ 1.5 ] Packaging |
| [ 1.5.1 ] Primary packaging |
| [ 1.5.1.7 ] Medicinal gases |
| [ 1.6 ] Quality control testing |
| [ 1.6.3 ] Chemical/Physical |