Medicines and Healthcare products Regulatory Agency
| 1: Authorisation Number | UK MIA(IMP) 242 |
|---|---|
| 2: Name of authorisation holder | JANSSEN-CILAG LIMITED |
| 3: Address(es) of manufacturing site(s) |
JANSSEN-CILAG LIMITED, 50-100 HOLMERS FARM WAY, HIGH WYCOMBE, HP12 4EG, UNITED KINGDOM |
| 4: Legally registered address of authorisation holder | JANSSEN-CILAG LIMITED, 50-100 HOLMERS FARM WAY, HIGH WYCOMBE, HP12 4EG, 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 | 25/03/2024 |
| 9: Annexes attached | Annex 1 and/or Annex 2 |
SCOPE OF AUTHORISATION
Annex 2
Name and address of the site:
JANSSEN-CILAG LIMITED, 50-100 HOLMERS FARM WAY, HIGH WYCOMBE, HP12 4EG, UNITED KINGDOM
Human Investigational Medicinal Products
| Authorised Operations |
| IMPORTATION OF MEDICINAL PRODUCTS (according to part 2) |
| Part 2 - IMPORTATION OF MEDICINAL PRODUCTS |
| [ 2.3 ] Other Importation Activities |
| [ 2.3.4 ] Other Importation of QP-certified IMPs from a country on the approved country for import list |