Medicines and Healthcare products Regulatory Agency

MANUFACTURER'S AUTHORISATION
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
Authorised Operations
IMPORTATION OF MEDICINAL PRODUCTS (according to part 2)
Operations
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