Medicines and Healthcare products Regulatory Agency

MANUFACTURER'S AUTHORISATION
1: Authorisation Number UK MIA(IMP) 19437
2: Name of authorisation holder MEDIMMUNE UK LIMITED
3: Address(es) of manufacturing site(s)

MEDIMMUNE UK LIMITED, PLOT 6 RENAISSANCE WAY, LIVERPOOL, L24 9JW, UNITED KINGDOM

4: Legally registered address of authorisation holder MEDIMMUNE UK LIMITED, PLOT 6 RENAISSANCE WAY, BOULEVARD INDUSTRY PARK, SPEKE, LIVERPOOL, L24 9JW, 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 27/06/2024
9: Annexes attached Annex 1 and/or Annex 2
SCOPE OF AUTHORISATION
Annex 2
Name and address of the site:

MEDIMMUNE UK LIMITED, PLOT 6 RENAISSANCE WAY, LIVERPOOL, L24 9JW, 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
    [ 1.1.1 ] Aseptically prepared (processing operations for the following dosage forms)
        [ 1.1.1.6 ] Other aseptically prepared products
            Sterile Monovalent Virus Harvest Bulk Product
[ 1.3 ] Biological investigational medicinal products
    [ 1.3.1 ] Biological medicinal products
        [ 1.3.1.2 ] Immunological products
    [ 1.3.2 ] Batch certification
        [ 1.3.2.2 ] Immunological products
[ 1.4 ] Other investigational medicinal products or manufacturing activitiy
    [ 1.4.2 ] Sterilisation of active substances/excipients/finished products:
        [ 1.4.2.1 ] Filtration
[ 1.6 ] Quality control testing
    [ 1.6.1 ] Microbiological: sterility
    [ 1.6.2 ] Microbiological: non-sterility
    [ 1.6.3 ] Chemical/Physical
    [ 1.6.4 ] Biological
Part 2 - IMPORTATION OF MEDICINAL PRODUCTS
[ 2.1 ] Quality control testing of imported medicinal products
    [ 2.1.1 ] Microbiological: sterility
    [ 2.1.2 ] Microbiological: non-sterility
    [ 2.1.3 ] Chemical/Physical
    [ 2.1.4 ] Biological
[ 2.2 ] Batch certification of imported medicinal products
    [ 2.2.1 ] Sterile Products
        [ 2.2.1.1 ] Aseptically prepared
    [ 2.2.3 ] Biological medicinal products
        [ 2.2.3.8 ] Other biological medicinal products
            Vaccine Products
[ 2.3 ] Other Importation Activities
    [ 2.3.1 ] Site of Physical Importation