Medicines and Healthcare products Regulatory Agency
| 1: Authorisation Number | UK MIA(IMP) 31 |
|---|---|
| 2: Name of authorisation holder | ROCHE PRODUCTS LIMITED |
| 3: Address(es) of manufacturing site(s) |
ROCHE PRODUCTS LIMITED, 6 FALCON WAY, SHIRE PARK, WELWYN GARDEN CITY, AL7 1TW, UNITED KINGDOM |
| 4: Legally registered address of authorisation holder | ROCHE PRODUCTS LIMITED, 6 FALCON WAY, SHIRE PARK, WELWYN GARDEN CITY, AL7 1TW, 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 | 30/01/2024 |
| 9: Annexes attached | Annex 1 and/or Annex 2 |
SCOPE OF AUTHORISATION
Annex 2
Name and address of the site:
ROCHE PRODUCTS LIMITED, 6 FALCON WAY, SHIRE PARK, WELWYN GARDEN CITY, AL7 1TW, 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 |
| [ 1.1 ] Sterile Investigational Medicinal Products |
| [ 1.1.3 ] Batch certification |
| [ 1.2 ] Non-sterile investigational medicinal products |
| [ 1.2.2 ] Batch certification |
| [ 1.3 ] Biological investigational medicinal products |
| [ 1.3.2 ] Batch certification |
| [ 1.3.2.2 ] Immunological products |
| [ 1.3.2.5 ] Biotechnology products |
| [ 1.3.2.6 ] Human or animal extracted products |
| [ 1.4 ] Other investigational medicinal products or manufacturing activitiy |
| [ 1.4.1 ] Manufacture of: |
| [ 1.4.1.3 ] Other Batch Certification of non-sterile products/Importation of QP certified IMPs from a country on the approved country for import list |
| 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 |
| [ 2.3 ] Other Importation Activities |
| [ 2.3.4 ] Other Batch Certification of non-sterile products/Importation of QP certified IMPs from a country on the approved country for import list |