ACCELERATE NEWCO LIMITED – MIA(IMP) 62229
| Authorisation Number | UK MIA(IMP) 62229 |
| Category | MIA(IMP) |
| Holder | ACCELERATE NEWCO LIMITED |
| Registered Address | ACCELERATE NEWCO LIMITED, STEPHENSON BUILDING, THE SCIENCE PARK, KEELE, NEWCASTLE, ST5 5SP, UNITED KINGDOM |
| Authorisation Date | Mar 27, 2026 |
| Legal Basis | InvestigationalPart 6 of The Medicines for Human Use (Clinical Trials) Regulations 2004 [SI 2004/1031] |
| Sites | 1 |
| Manufacturing Operations | 1.1 1.1.1 1.1.1.4 1.2 1.2.1 1.2.1.15 1.2.1.6 1.3 1.3.1 1.3.1.2 1.3.1.4 1.3.1.5 1.3.1.8 1.3.2 1.3.2.2 1.3.2.4 1.3.2.5 1.4 1.4.2 1.4.2.1 1.4.2.3 1.6 1.6.2 1.6.3 1.6.4 |
| Importation Operations | 2.1 2.1.2 2.1.3 2.1.4 2.2 2.2.1 2.2.1.1 2.2.1.2 2.2.2 2.2.3 2.2.3.2 2.2.3.3 2.2.3.4 2.2.3.5 2.2.3.6 2.2.3.8 |
| MHRA Link | View on MHRA Website |
Sites (1)
ACCELERATE NEWCO LIMITED
BOTH
Country: UNITED KINGDOMProduct Class: Human Investigational Medicinal Products
Manufacturing
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
1.2 — Non-sterile investigational medicinal products
1.2.1 — Non-Sterile Products (processing operations for the following dosage forms)
1.2.1.6 — Liquids for internal use
1.2.1.15 — Other non-sterile medicinal products
1.3 — Biological investigational medicinal products
1.3.1 — Biological medicinal products
1.3.1.2 — Immunological products
1.3.1.4 — Gene therapy products
1.3.1.5 — Biotechnology products
1.3.1.8 — Other biological medicinal products
1.3.2 — Batch certification
1.3.2.2 — Immunological products
1.3.2.4 — Gene therapy products
1.3.2.5 — Biotechnology products
1.4 — Other investigational medicinal products or manufacturing activitiy
1.4.2 — Sterilisation of active substances/excipients/finished products:
1.4.2.1 — Filtration
1.4.2.3 — Moist heat
1.6 — Quality control testing
1.6.2 — Microbiological: non-sterility
1.6.3 — Chemical/Physical
1.6.4 — Biological
Importation
2.1 — Quality control testing of imported medicinal products
2.1.2 — Microbiological: non-sterility
2.1.3 — Chemical/Physical
2.1.4 — Biological
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
2.2.3.2 — 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
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