Medicines and Healthcare products Regulatory Agency
| 1: Authorisation Number | UK MIA(IMP) 58032 |
|---|---|
| 2: Name of authorisation holder | RENTSCHLER ATMP LIMITED |
| 3: Address(es) of manufacturing site(s) |
RENTSCHLER ATMP LIMITED, MODULE 12, CELL & GENE THERAPY CATAPULT MANUFACTURING CENTRE, GUNNELS WOOD ROAD, STEVENAGE, SG1 2FX, UNITED KINGDOM RENTSCHLER ATMP LIMITED, SYCAMORE HOUSE, LEYDEN ROAD, STEVENAGE, SG1 2BP, UNITED KINGDOM |
| 4: Legally registered address of authorisation holder | RENTSCHLER ATMP LIMITED, 4 FLEET PLACE, LONDON, EC4M 7RD, 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 | 14/05/2024 |
| 9: Annexes attached | Annex 1 and/or Annex 2 |
SCOPE OF AUTHORISATION
Annex 2
Name and address of the site:
RENTSCHLER ATMP LIMITED, MODULE 12, CELL & GENE THERAPY CATAPULT MANUFACTURING CENTRE, GUNNELS WOOD ROAD, STEVENAGE, SG1 2FX, UNITED KINGDOM
Human Investigational Medicinal Products
| Authorised Operations |
| MANUFACTURING OPERATIONS (according to part 1) |
| Part 1 - MANUFACTURING OPERATIONS |
| [ 1.3 ] Biological investigational medicinal products |
| [ 1.3.1 ] Biological medicinal products |
| [ 1.3.1.4 ] Gene therapy products |
| [ 1.3.1.5 ] Biotechnology products |
| [ 1.4 ] Other investigational medicinal products or manufacturing activitiy |
| [ 1.4.1 ] Manufacture of: |
| [ 1.4.1.3 ] Other Environmental monitoring or process simulation (media fill) to support sterile manufacture |
| [ 1.6 ] Quality control testing |
| [ 1.6.3 ] Chemical/Physical |
| [ 1.6.4 ] Biological |
SCOPE OF AUTHORISATION
Annex 2
Name and address of the site:
RENTSCHLER ATMP LIMITED, SYCAMORE HOUSE, LEYDEN ROAD, STEVENAGE, SG1 2BP, UNITED KINGDOM
Human Investigational Medicinal Products
| Authorised Operations |
| MANUFACTURING OPERATIONS (according to part 1) |
| Part 1 - MANUFACTURING OPERATIONS |
| [ 1.6 ] Quality control testing |
| [ 1.6.2 ] Microbiological: non-sterility |
| [ 1.6.3 ] Chemical/Physical |
| [ 1.6.4 ] Biological |