Medicines and Healthcare products Regulatory Agency
| 1: Authorisation Number | UK MIA(IMP) 11184 |
|---|---|
| 2: Name of authorisation holder | BRISTOL-MYERS SQUIBB PHARMACEUTICALS LIMITED |
| 3: Address(es) of manufacturing site(s) |
BRISTOL-MYERS SQUIBB PHARMACEUTICALS LIMITED, REEDS LANE MORETON, WIRRAL, CH46 1QW, UNITED KINGDOM |
| 4: Legally registered address of authorisation holder | BRISTOL-MYERS SQUIBB PHARMACEUTICALS LIMITED, BMS HOUSE, UXBRIDGE BUSINESS PARK, SANDERSON ROAD, UXBRIDGE, UB8 1DH, 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 | 25/05/2022 |
| 9: Annexes attached | Annex 1 and/or Annex 2 |
SCOPE OF AUTHORISATION
Annex 2
Name and address of the site:
BRISTOL-MYERS SQUIBB PHARMACEUTICALS LIMITED, REEDS LANE MORETON, WIRRAL, CH46 1QW, 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 |
| [ 1.3.2.8 ] Other biological medicinal products MDX-010 (Impilimumab), Anti-CD 137 and Erbitux |
| [ 1.5 ] Packaging |
| [ 1.5.1 ] Primary packaging |
| [ 1.5.1.1 ] Capsules, hard shell |
| [ 1.5.1.13 ] Tablets |
| [ 1.5.2 ] Secondary packaging |
| [ 1.6 ] Quality control testing |
| [ 1.6.3 ] Chemical/Physical |
| Part 2 - IMPORTATION OF MEDICINAL PRODUCTS |
| [ 2.1 ] Quality control testing of imported medicinal products |
| [ 2.1.3 ] Chemical/Physical |
| [ 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 |
| [ 2.2.3.8 ] Other biological medicinal products MDX-010 (Impilimumab), Anti-CD 137 and Erbitux |
| [ 2.3 ] Other Importation Activities |
| [ 2.3.1 ] Site of Physical Importation |
| [ 2.3.2 ] Importation of Intermediate which undergoes further processing |
| [ 2.3.4 ] Other Importation of QP certified IMPs from a country on the approved country for import list |
Any restrictions or clarifying remarks
QP Mrs Annelies Jorritsma-Smit is included on this licence solely for the oversight of imported IMPs following certification in an approved country in accordance with the provisions of Regulation 43(1) of UK SI 2004/1031 (as amended). Mrs Annelies Jorritsma-Smit may not undertake QP certification of other activities performed under this MIA(IMP).