Medicines and Healthcare products Regulatory Agency
| 1: Authorisation Number | UK MIA 17854 |
|---|---|
| 2: Name of authorisation holder | UNIVERSITY HOSPITALS OF DERBY AND BURTON NHS FOUNDATION TRUST |
| 3: Address(es) of manufacturing site(s) |
QUEENS HOSPITALS, BURTON, PHARMACY MANUFACTURING UNIT, QUEENS HOSPITAL, BELVEDERE ROAD, BURTON-ON-TRENT, DE13 0RB, UNITED KINGDOM |
| 4: Legally registered address of authorisation holder | UNIVERSITY HOSPITALS OF DERBY AND BURTON NHS FOUNDATION TRUST, PHARMACY MANUFACTURING UNIT, QUEENS HOSPITAL, BELVEDERE ROAD, BURTON-ON-TRENT, DE13 0RB, 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 | 11/08/2022 |
| 9: Annexes attached | Annex 1 and/or Annex 2 |
SCOPE OF AUTHORISATION
Annex 1
Name and address of the site:
QUEENS HOSPITALS, BURTON, PHARMACY MANUFACTURING UNIT, QUEENS HOSPITAL, BELVEDERE ROAD, BURTON-ON-TRENT, DE13 0RB, UNITED KINGDOM
Human Medicinal Products
| Authorised Operations |
| MANUFACTURING OPERATIONS (according to part 1) |
| Part 1 - MANUFACTURING OPERATIONS |
| [ 1.1 ] Sterile Products |
| [ 1.1.2 ] Terminally Sterilised (processing operations for the following dosage forms) |
| [ 1.1.2.1 ] Large volume liquids |
| [ 1.1.2.3 ] Small volume liquids |
| [ 1.1.3 ] Batch certification |
| [ 1.2 ] Non-sterile 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 |
| [ 1.2.1.17 ] Other non-sterile medicinal products Bismuth and Iodoform Paste / Impregnated Gauze |
| [ 1.2.2 ] Batch certification |
| [ 1.4 ] Other products or manufacturing activity |
| [ 1.4.1 ] Manufacture of: |
| [ 1.4.1.1 ] Herbal products |
| [ 1.4.2 ] Sterilisation of active substances/excipients/finished products: |
| [ 1.4.2.3 ] Moist heat |
| [ 1.5 ] Packaging |
| [ 1.5.2 ] Secondary packaging |
| [ 1.6 ] Quality control testing |
| [ 1.6.2 ] Microbiological: non-sterility |
| [ 1.6.3 ] Chemical/Physical |