Medicines and Healthcare products Regulatory Agency
| 1: Authorisation Number | UK MIA(IMP) 32390 |
|---|---|
| 2: Name of authorisation holder | THERMO ELECTRON LIMITED |
| 3: Address(es) of manufacturing site(s) |
THERMO ELECTRON LIMITED, THERMO FISHER SCIENTIFIC, FISHER BIOSERVICES DIVISION, UNIT 1, WOODSIDE, DUNMOW ROAD, BIRCHANGER, BISHOP'S STORTFORD, CM23 5RG, UNITED KINGDOM |
| 4: Legally registered address of authorisation holder | THERMO ELECTRON LIMITED, 3RD FLOOR, 1 ASHLEY ROAD, ALTRINCHAM, WA14 2DT, UNITED KINGDOM |
| 5: Scope of authorisation and dosage forms | ANNEX 1 and/ or ANNEX 2 |
| 6: Legal Basis of authorisation | |
| 7: Name of responsible officer of the competent authority of the member state granting the manufacturing authorisation | Confidential |
| 8: Authorisation Date | 29/01/2024 |
| 9: Annexes attached | Annex 1 and/or Annex 2 |
SCOPE OF AUTHORISATION
Annex 2
Name and address of the site:
THERMO ELECTRON LIMITED, THERMO FISHER SCIENTIFIC, FISHER BIOSERVICES DIVISION, UNIT 1, WOODSIDE, DUNMOW ROAD, BIRCHANGER, BISHOP'S STORTFORD, CM23 5RG, UNITED KINGDOM
Human Investigational Medicinal Products
| Authorised Operations |
| MANUFACTURING OPERATIONS (according to part 1)IMPORTATION OF MEDICINAL PRODUCTS (according to part 2) |
| Part 1 - MANUFACTURING OPERATIONS |
| [ 1.4 ] Other investigational medicinal products or manufacturing activitiy |
| [ 1.4.1 ] Manufacture of: |
| [ 1.4.1.3 ] Other Authorised for 'Primary labelling- not primary packaging, no open primary containers/ Importation of QP certified IMPs from a country on the 'approved country for import list' |
| [ 1.5 ] Packaging |
| [ 1.5.2 ] Secondary packaging |
| Part 2 - IMPORTATION OF MEDICINAL PRODUCTS |
| [ 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 Cell banks |
| [ 2.3 ] Other Importation Activities |
| [ 2.3.1 ] Site of Physical Importation |
| [ 2.3.2 ] Importation of Intermediate which undergoes further processing |
| [ 2.3.3 ] Biological Active Substance |
| [ 2.3.4 ] Other Authorised for 'Primary labelling- not primary packaging, no open primary containers/ Importation of QP certified IMPs from a country on the 'approved country for import list' |