ASTRAZENECA UK LIMITED – MIA(IMP) 17901
| Authorisation Number | UK MIA(IMP) 17901 |
| Category | MIA(IMP) |
| Holder | ASTRAZENECA UK LIMITED |
| Registered Address | ASTRAZENECA UK LIMITED, 1 FRANCIS CRICK AVENUE, CAMBRIDGE BIOMEDICAL CAMPUS, CAMBRIDGE, CB2 0AA, UNITED KINGDOM |
| Authorisation Date | Mar 31, 2026 |
| Legal Basis | InvestigationalPart 6 of The Medicines for Human Use (Clinical Trials) Regulations 2004 [SI 2004/1031] |
| Sites | 1 |
| Manufacturing Operations | 1.1 1.1.3 1.2 1.2.2 1.3 1.3.2 1.3.2.5 1.6 1.6.1 1.6.2 1.6.3 |
| Importation Operations | 2.1 2.1.1 2.1.2 2.1.3 2.2 2.2.1 2.2.1.1 2.2.1.2 2.2.2 2.2.3 2.2.3.5 2.3 2.3.2 2.3.4 |
| MHRA Link | View on MHRA Website |
Sites (1)
ASTRAZENECA UK LIMITED - MACCLESFIELD DEVELOPMENT
BOTH
Country: UNITED KINGDOMProduct Class: Human Investigational Medicinal Products
Manufacturing
1.1 — Sterile Investigational Medicinal Products
1.1.3 — Batch certification
1.2 — Non-sterile investigational medicinal products
1.2.2 — Batch certification
1.3 — Biological investigational medicinal products
1.3.2 — Batch certification
1.3.2.5 — Biotechnology products
1.6 — Quality control testing
1.6.1 — Microbiological: sterility
1.6.2 — Microbiological: non-sterility
1.6.3 — Chemical/Physical
Importation
2.1 — Quality control testing of imported medicinal products
2.1.1 — Microbiological: sterility
2.1.2 — Microbiological: non-sterility
2.1.3 — Chemical/Physical
2.2 — Batch certification of imported medicinal products
2.2.1 — Sterile Products
2.2.1.1 — Aseptically prepared
2.2.1.2 — Terminally sterilised
2.2.2 — Non-sterile products
2.2.3 — Biological medicinal products
2.2.3.5 — Biotechnology products
2.3 — Other Importation Activities
2.3.2 — Importation of Intermediate which undergoes further processing
2.3.4 — Other
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