Medicines and Healthcare products Regulatory Agency

MANUFACTURER'S AUTHORISATION
1: Authorisation Number UK MIA 21538
2: Name of authorisation holder TERUMO BCT LTD.
3: Address(es) of manufacturing site(s)

TERUMO BCT LIMITED, OLD BELFAST ROAD, MILLBROOK, LARNE, BT40 2SH, UNITED KINGDOM

4: Legally registered address of authorisation holder TERUMO BCT LTD., OLD BELFAST ROAD, MILLBROOK, LARNE, BT40 2SH, 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 18/12/2023
9: Annexes attached Annex 1 and/or Annex 2
SCOPE OF AUTHORISATION
Annex 1
Name and address of the site:

TERUMO BCT LIMITED, OLD BELFAST ROAD, MILLBROOK, LARNE, BT40 2SH, UNITED KINGDOM

Human Medicinal Products
Authorised Operations
Authorised Operations
MANUFACTURING OPERATIONS (according to part 1)
Operations
Part 1 - MANUFACTURING OPERATIONS
[ 1.1 ] Sterile Products
    [ 1.1.2 ] Terminally Sterilised (processing operations for the following dosage forms)
        [ 1.1.2.1 ] Large volume liquids
        [ 1.1.2.3 ] Small volume liquids
[ 1.2 ] Non-sterile products
    [ 1.2.1 ] Non-Sterile Products (processing operations for the following dosage forms)
        [ 1.2.1.5 ] Liquids for external use
[ 1.4 ] Other products or manufacturing activity
    [ 1.4.2 ] Sterilisation of active substances/excipients/finished products:
        [ 1.4.2.3 ] Moist heat
[ 1.5 ] Packaging
    [ 1.5.2 ] Secondary packaging
[ 1.6 ] Quality control testing
    [ 1.6.1 ] Microbiological: sterility
    [ 1.6.2 ] Microbiological: non-sterility
    [ 1.6.3 ] Chemical/Physical