FORTREA CLINICAL RESEARCH UNIT LIMITED – MIA(IMP) 13101
| Authorisation Number | UK MIA(IMP) 13101 |
| Category | MIA(IMP) |
| Holder | FORTREA CLINICAL RESEARCH UNIT LIMITED |
| Registered Address | FORTREA CLINICAL RESEARCH UNIT LIMITED, DRAPERS YARD, MARSHALL STREET, LEEDS, LS11 9EH, UNITED KINGDOM |
| Authorisation Date | Jul 03, 2025 |
| 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 1.1.1.1 1.1.1.4 1.1.1.6 1.1.3 1.2 1.2.1 1.2.1.1 1.2.1.15 1.2.1.5 1.2.1.6 1.2.1.8 1.2.2 1.3 1.3.1 1.3.1.8 1.3.2 1.3.2.8 1.4 1.4.1 1.4.1.3 1.4.2 1.4.2.1 1.5 1.5.1 1.5.1.1 1.5.1.11 1.5.1.12 1.5.1.13 1.5.1.14 1.5.1.2 1.5.1.3 1.5.1.4 1.5.1.5 1.5.1.6 1.5.1.8 1.5.2 1.6 1.6.3 |
| Importation Operations | 2.2 2.2.1 2.2.1.1 2.2.1.2 2.2.2 2.2.3 2.2.3.2 2.2.3.5 2.2.3.6 2.3 2.3.1 2.3.2 |
| MHRA Link | View on MHRA Website |
Sites (1)
FORTREA CLINICAL RESEARCH UNIT 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)
1.1.1.1 — Large volume liquids
1.1.1.4 — Small volume liquids
1.1.1.6 — Other aseptically prepared products
1.1.3 — Batch certification
1.2 — Non-sterile investigational medicinal products
1.2.1 — Non-Sterile Products (processing operations for the following dosage forms)
1.2.1.1 — Capsules, hard shell
1.2.1.5 — Liquids for external use
1.2.1.6 — Liquids for internal use
1.2.1.8 — Other solid dosage forms
1.2.1.15 — Other non-sterile medicinal products
1.2.2 — Batch certification
1.3 — Biological investigational medicinal products
1.3.1 — Biological medicinal products
1.3.1.8 — Other biological medicinal products
1.3.2 — Batch certification
1.3.2.8 — Other biological medicinal products
1.4 — Other investigational medicinal products or manufacturing activitiy
1.4.1 — Manufacture of:
1.4.1.3 — Other
1.4.2 — Sterilisation of active substances/excipients/finished products:
1.4.2.1 — Filtration
1.5 — Packaging
1.5.1 — Primary packaging
1.5.1.1 — Capsules, hard shell
1.5.1.2 — Capsules, soft shell
1.5.1.3 — Chewing gums
1.5.1.4 — Impregnated matrices
1.5.1.5 — Liquids for external use
1.5.1.6 — Liquids for internal use
1.5.1.8 — Other solid dosage forms
1.5.1.11 — Semi-solids
1.5.1.12 — Suppositories
1.5.1.13 — Tablets
1.5.1.14 — Transdermal patches
1.5.2 — Secondary packaging
1.6 — Quality control testing
1.6.3 — Chemical/Physical
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
2.2.3.2 — Immunological 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
Content Preview
The source document is available on KeyPedia. Sign in to view.