Medicines and Healthcare products Regulatory Agency

MANUFACTURER'S AUTHORISATION
1: Authorisation Number UK MIA(IMP) 30013
2: Name of authorisation holder PHARMARON BIOLOGICS (UK) LTD
3: Address(es) of manufacturing site(s)

PHARMARON BIOLOGICS (UK) LTD, NATIONAL BIOMANUFACTURING CENTRE, ESTUARY BANKS, ESTUARY COMMERCE PARK, SPEKE ROAD, LIVERPOOL, L24 8RB, UNITED KINGDOM

4: Legally registered address of authorisation holder PHARMARON BIOLOGICS (UK) LTD, NATIONAL BIOMANUFACTURING CENTRE, ESTUARY BANKS, ESTUARY COMMERCE PARK, SPEKE ROAD, LIVERPOOL, L24 8RB, 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 25/10/2021
9: Annexes attached Annex 1 and/or Annex 2
SCOPE OF AUTHORISATION
Annex 2
Name and address of the site:

PHARMARON BIOLOGICS (UK) LTD, NATIONAL BIOMANUFACTURING CENTRE, ESTUARY BANKS, ESTUARY COMMERCE PARK, SPEKE ROAD, LIVERPOOL, L24 8RB, UNITED KINGDOM

Human Investigational Medicinal Products
Authorised Operations
Authorised Operations
MANUFACTURING OPERATIONS (according to part 1)
IMPORTATION OF MEDICINAL PRODUCTS (according to part 2)
Operations
Part 1 - MANUFACTURING OPERATIONS
[ 1.1 ] Sterile Investigational Medicinal Products
    [ 1.1.3 ] Batch certification
[ 1.2 ] Non-sterile investigational medicinal products
    [ 1.2.2 ] Batch certification
[ 1.3 ] Biological investigational medicinal products
    [ 1.3.1 ] Biological medicinal products
        [ 1.3.1.2 ] Immunological products
        [ 1.3.1.3 ] Cell therapy products
        [ 1.3.1.4 ] Gene therapy products
        [ 1.3.1.5 ] Biotechnology products
        [ 1.3.1.6 ] Human or animal extracted products
        [ 1.3.1.8 ] Other biological medicinal products
            Biological Active Starting Materials
[ 1.6 ] Quality control testing
    [ 1.6.2 ] Microbiological: non-sterility
    [ 1.6.3 ] Chemical/Physical
    [ 1.6.4 ] Biological
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
        [ 2.2.1.2 ] Terminally sterilised
    [ 2.2.2 ] Non-sterile products
    [ 2.2.3 ] Biological medicinal products
        [ 2.2.3.2 ] Immunological products
        [ 2.2.3.3 ] Cell therapy products
        [ 2.2.3.4 ] Gene therapy products
        [ 2.2.3.5 ] Biotechnology products
        [ 2.2.3.6 ] Human or animal extracted products
        [ 2.2.3.8 ] Other biological medicinal products
            Biological Active Starting Materials