Medicines and Healthcare products Regulatory Agency
| 1: Authorisation Number | UK MIA(IMP) 20363 |
|---|---|
| 2: Name of authorisation holder | UNIVERSITY COLLEGE LONDON |
| 3: Address(es) of manufacturing site(s) |
UCL GMP FACILITY, UCL RADIOCHEMISTRY, KATHLEEN LONSDALE BUILDING, 5 GOWER PLACE, LONDON, WC1E 6BS, UNITED KINGDOM |
| 4: Legally registered address of authorisation holder | UNIVERSITY COLLEGE LONDON, UCL RADIOCHEMISTRY, KATHLEEN LONSDALE BUILDING, 5 GOWER PLACE, LONDON, WC1E 6BS, 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 | 07/06/2023 |
| 9: Annexes attached | Annex 1 and/or Annex 2 |
SCOPE OF AUTHORISATION
Annex 2
Name and address of the site:
UCL GMP FACILITY, UCL RADIOCHEMISTRY, KATHLEEN LONSDALE BUILDING, 5 GOWER PLACE, LONDON, WC1E 6BS, UNITED KINGDOM
Human Investigational Medicinal Products
| Authorised Operations |
| MANUFACTURING OPERATIONS (according to part 1) |
| Part 1 - MANUFACTURING OPERATIONS |
| [ 1.1 ] Sterile Investigational Medicinal Products |
| [ 1.1.1 ] Aseptically prepared (processing operations for the following dosage forms) |
| [ 1.1.1.4 ] Small volume liquids Special Requirements Radiopharmaceuticals |
| [ 1.1.1.6 ] Other aseptically prepared products Radiopharmaceuticals for injection (Short lived radio-isotopes). Hyperpolarised Products for injection (Research use only) Special Requirements Radiopharmaceuticals |
| [ 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 |
| [ 1.5.1.6 ] Liquids for internal use |
| [ 1.5.2 ] Secondary packaging |
| [ 1.6 ] Quality control testing |
| [ 1.6.2 ] Microbiological: non-sterility |
| [ 1.6.3 ] Chemical/Physical |