BIOTEC SERVICES INTERNATIONAL LIMITED – MIA 19819
| Authorisation Number | UK MIA 19819 |
| Category | MIA |
| Holder | BIOTEC SERVICES INTERNATIONAL LIMITED |
| Registered Address | BIOTEC SERVICES INTERNATIONAL LIMITED, BIOTEC HOUSE, CENTRAL PARK, WESTERN AVENUE, BRIDGEND INDUSTRIAL ESTATE, BRIDGEND, CF31 3RT, UNITED KINGDOM |
| Authorisation Date | Jul 14, 2025 |
| Legal Basis | HumanRegulation 17 of The Human Medicines Regulations 2012 (SI 2012/1916) |
| Sites | 2 |
| Manufacturing Operations | 1.1 1.1.3 1.2 1.2.2 1.3 1.3.1 1.3.1.1 1.3.1.2 1.3.1.3 1.3.1.4 1.3.1.5 1.3.1.6 1.3.2 1.3.2.1 1.3.2.2 1.3.2.3 1.3.2.4 1.3.2.5 1.3.2.6 1.3.2.7 1.3.2.8 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 2.2.3.7 2.2.3.8 2.3 2.3.1 |
| MHRA Link | View on MHRA Website |
Sites (2)
BIOTEC SERVICES INTERNATIONAL LIMITED
BOTH
Country: UNITED KINGDOMProduct Class: Human Medicinal Products
Manufacturing
1.1 — Sterile Products
1.1.3 — Batch certification
1.2 — Non-sterile products
1.2.2 — Batch certification
1.3 — Biological medicinal products
1.3.1 — Biological medicinal products
1.3.1.1 — Blood products
1.3.1.2 — Immunological products
1.3.1.3 — Cell therapy products
1.3.1.4 — Gene therapy products
1.3.1.5 — Biotechnology products
1.3.1.6 — Human or animal extracted products
1.3.2 — Batch certification
1.3.2.1 — Blood products
1.3.2.2 — Immunological products
1.3.2.3 — Cell therapy products
1.3.2.4 — Gene therapy products
1.3.2.5 — Biotechnology products
1.3.2.6 — Human or animal extracted products
1.3.2.7 — Tissue Engineered Products
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
2.2.3.7 — Tissue Engineered Products
2.2.3.8 — Other biological medicinal products
2.3 — Other Importation Activities
2.3.1 — Site of Physical Importation
BIOTEC SERVICES INTERNATIONAL LIMITED
BOTH
Country: UNITED KINGDOMProduct Class: Human Medicinal Products
Manufacturing
1.1 — Sterile Products
1.1.3 — Batch certification
1.2 — Non-sterile products
1.2.2 — Batch certification
1.3 — Biological medicinal products
1.3.2 — Batch certification
1.3.2.1 — Blood products
1.3.2.2 — Immunological products
1.3.2.3 — Cell therapy products
1.3.2.4 — Gene therapy products
1.3.2.5 — Biotechnology products
1.3.2.6 — Human or animal extracted products
1.3.2.7 — Tissue Engineered Products
1.3.2.8 — Other biological medicinal products
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
2.2.3.7 — Tissue Engineered Products
2.3 — Other Importation Activities
2.3.1 — Site of Physical Importation
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