Medicines and Healthcare products Regulatory Agency

MANUFACTURER'S AUTHORISATION
1: Authorisation Number UK MIA 42657
2: Name of authorisation holder GLAXOSMITHKLINE TRADING SERVICES LIMITED
3: Address(es) of manufacturing site(s)

GLAXO OPERATIONS UK LTD TRADING AS GLAXO WELLCOME OPERATIONS, HARMIRE ROAD, BARNARD CASTLE, DL12 8DT, UNITED KINGDOM

4: Legally registered address of authorisation holder GLAXOSMITHKLINE TRADING SERVICES LIMITED, 980 GREAT WEST ROAD, BRENTFORD, TW8 9GS, 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 28/02/2024
9: Annexes attached Annex 1 and/or Annex 2
SCOPE OF AUTHORISATION
Annex 1
Name and address of the site:

GLAXO OPERATIONS UK LTD TRADING AS GLAXO WELLCOME OPERATIONS, HARMIRE ROAD, BARNARD CASTLE, DL12 8DT, UNITED KINGDOM

Human Medicinal Products
Authorised Operations
Authorised Operations
IMPORTATION OF MEDICINAL PRODUCTS (according to part 2)
Operations
Part 2 - IMPORTATION OF MEDICINAL PRODUCTS
[ 2.2 ] Batch certification of imported medicinal products
    [ 2.2.1 ] Sterile Products
        [ 2.2.1.1 ] Aseptically prepared
    [ 2.2.2 ] Non-sterile products