SMIRO QUALITAS MANUFACTURING LTD – MIA(IMP) 62112
| Authorisation Number | UK MIA(IMP) 62112 |
| Category | MIA(IMP) |
| Holder | SMIRO QUALITAS MANUFACTURING LTD |
| Registered Address | SMIRO QUALITAS MANUFACTURING LTD, 4 FLATFORD ROAD, HAVERHILL, CB9 7WW, UNITED KINGDOM |
| Authorisation Date | Jun 08, 2026 |
| Legal Basis | InvestigationalPart 6 of The Medicines for Human Use (Clinical Trials) Regulations 2004 [SI 2004/1031] |
| Sites | 2 |
| Manufacturing Operations | 1.5 1.5.2 |
| Importation Operations | 2.2 2.2.1 2.2.1.1 2.2.1.2 2.2.2 2.2.3 2.2.3.1 2.2.3.2 2.2.3.3 2.2.3.4 2.2.3.5 2.2.3.6 2.2.3.8 2.3 2.3.1 2.3.2 2.3.4 |
| MHRA Link | View on MHRA Website |
Sites (2)
SMIRO QUALITAS MANUFACTURING LTD
IMPORTATION_SITE
Country: UNITED KINGDOMProduct Class: Human Investigational Medicinal Products
Importation
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
2.2.3 — Biological medicinal products
2.2.3.1 — Blood products
2.2.3.2 — Immunological products
2.2.3.3 — Cell therapy products
2.2.3.4 — Gene therapy products
2.2.3.5 — Biotechnology products
2.2.3.6 — Human or animal extracted products
2.2.3.8 — Other biological medicinal products
2.3 — Other Importation Activities
2.3.4 — Other
SMIRO QUALITAS MANUFACTURING LTD
BOTH
Country: UNITED KINGDOMProduct Class: Human Investigational Medicinal Products
Manufacturing
1.5 — Packaging
1.5.2 — Secondary packaging
Importation
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
2.2.3.1 — Blood products
2.2.3.2 — Immunological products
2.2.3.3 — Cell therapy products
2.2.3.4 — Gene therapy products
2.2.3.5 — Biotechnology products
2.2.3.6 — Human or animal extracted products
2.3 — Other Importation Activities
2.3.1 — Site of Physical Importation
2.3.2 — Importation of Intermediate which undergoes further processing
2.3.4 — Other
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