Medicines and Healthcare products Regulatory Agency

MANUFACTURER'S AUTHORISATION
1: Authorisation Number UK MIA(IMP) 116
2: Name of authorisation holder BAXTER HEALTHCARE LIMITED
3: Address(es) of manufacturing site(s)

BAXTER HEALTHCARE LIMITED, UNIT B, TAURUS BUILDING, PETERLEY ROAD, COWLEY, OXFORD, OX4 2TZ, UNITED KINGDOM

4: Legally registered address of authorisation holder BAXTER HEALTHCARE LIMITED, CAXTON WAY, THETFORD, IP24 3SE, 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 10/06/2024
9: Annexes attached Annex 1 and/or Annex 2
SCOPE OF AUTHORISATION
Annex 2
Name and address of the site:

BAXTER HEALTHCARE LIMITED, UNIT B, TAURUS BUILDING, PETERLEY ROAD, COWLEY, OXFORD, OX4 2TZ, UNITED KINGDOM

Human Investigational Medicinal Products
Authorised Operations
Authorised Operations
MANUFACTURING OPERATIONS (according to part 1)
Operations
Part 1 - MANUFACTURING OPERATIONS
[ 1.1 ] Sterile Investigational Medicinal Products
    [ 1.1.1 ] Aseptically prepared (processing operations for the following dosage forms)
        [ 1.1.1.1 ] Large volume liquids
        [ 1.1.1.4 ] Small volume liquids
        [ 1.1.1.6 ] Other aseptically prepared products
            Cytotoxics, Monoclonal antibodies
[ 1.3 ] Biological investigational medicinal products
    [ 1.3.1 ] Biological medicinal products
        [ 1.3.1.2 ] Immunological products
        [ 1.3.1.8 ] Other biological medicinal products
            Non Cytotoxic & Cytotoxic-Monoclonal Antibodies
    [ 1.3.2 ] Batch certification
        [ 1.3.2.2 ] Immunological products
        [ 1.3.2.8 ] Other biological medicinal products
            Non Cytotoxic & Cytotoxic-Monoclonal Antibodies
[ 1.5 ] Packaging
    [ 1.5.2 ] Secondary packaging
[ 1.6 ] Quality control testing
    [ 1.6.2 ] Microbiological: non-sterility