Medicines and Healthcare products Regulatory Agency
| 1: Authorisation Number | UK MIA(IMP) 46616 |
|---|---|
| 2: Name of authorisation holder | REPLIMUNE LIMITED |
| 3: Address(es) of manufacturing site(s) |
REPLIMUNE LIMITED, 69 INNOVATION DRIVE, MILTON PARK, MILTON, ABINGDON, OX14 4RQ, UNITED KINGDOM |
| 4: Legally registered address of authorisation holder | REPLIMUNE LIMITED, 69 INNOVATION DRIVE, MILTON PARK, MILTON, ABINGDON, OX14 4RQ, 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 | 21/04/2026 |
| 9: Annexes attached | Annex 1 and/or Annex 2 |
SCOPE OF AUTHORISATION
Annex 2
Name and address of the site:
REPLIMUNE LIMITED, 69 INNOVATION DRIVE, MILTON PARK, MILTON, ABINGDON, OX14 4RQ, UNITED KINGDOM
Human Investigational Medicinal Products
| Authorised Operations |
| MANUFACTURING OPERATIONS (according to part 1) |
| 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 |
| [ 1.3.1 ] Biological medicinal products |
| [ 1.3.1.4 ] Gene therapy products Special Requirements Selectively replication competent Herpes simplex virus that contain various transgenes intended to simulate immune responses. These products are administered by direct tumour injection into suitable non-neurological solid tumours |
| [ 1.3.2 ] Batch certification |
| [ 1.3.2.4 ] Gene therapy products Special Requirements Selectively replication competent Herpes simplex virus that contain various transgenes intended to simulate immune responses. These products are administered by direct tumour injection into suitable non-neurological solid tumours |
| [ 1.3.2.5 ] Biotechnology products Special Requirements According to the commercial product SmPC |
| [ 1.6 ] Quality control testing |
| [ 1.6.3 ] Chemical/Physical |
| [ 1.6.4 ] Biological |