Medicines and Healthcare products Regulatory Agency

MANUFACTURER'S AUTHORISATION
1: Authorisation Number UK MIA(IMP) 14620
2: Name of authorisation holder BARTS HEALTH NHS TRUST
3: Address(es) of manufacturing site(s)

BARTS HEALTH NHS TRUST (NUCLEAR MEDICINE RADIOPHARMACY UNIT BASEMENT), NUCLEAR MEDICINE- RADIOPHARMACY, BASEMENT, KING GEORGE V WING, ST BARTHOLOMEW'S HOSPITAL, WEST SMITHFIELD, LONDON, EC1A 7BE, UNITED KINGDOM

BARTS HEALTH NHS TRUST (PHARMACY CHEMOTHERAPY UNIT 7TH FLOOR), DEPARTMENT OF PHARMACY- PHARMACY CHEMOTHERAPY UNIT, 7TH FLOOR, KING GEORGE V WING, ST BARTHOLOMEW'S HOSPITAL, WEST SMITHFIELD, LONDON, EC1A 7BE, UNITED KINGDOM

BARTS HEALTH NHS TRUST, PHARMACY TECHNICAL SERVICES, 1ST FLOOR PATHOLOGY & PHARMACY BUILDING, ROYAL LONDON HOSPITAL ,80 NEWARK STREET, LONDON, E1 2ES, UNITED KINGDOM

4: Legally registered address of authorisation holder BARTS HEALTH NHS TRUST, 80 NEWARK STREET, WHITECHAPEL, LONDON, E1 2ES, 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 01/07/2024
9: Annexes attached Annex 1 and/or Annex 2
SCOPE OF AUTHORISATION
Annex 2
Name and address of the site:

BARTS HEALTH NHS TRUST (NUCLEAR MEDICINE RADIOPHARMACY UNIT BASEMENT), NUCLEAR MEDICINE- RADIOPHARMACY, BASEMENT, KING GEORGE V WING, ST BARTHOLOMEW'S HOSPITAL, WEST SMITHFIELD, LONDON, EC1A 7BE, 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)
        [ 1.1.1.4 ] Small volume liquids
        [ 1.1.1.6 ] Other aseptically prepared products
            Radiopharmaceuticals / Radionuclide Generators/ IMP product dispensing, large and small volumes diagnostic purposes
    [ 1.1.3 ] Batch certification
[ 1.4 ] Other investigational medicinal products or manufacturing activitiy
    [ 1.4.2 ] Sterilisation of active substances/excipients/finished products:
        [ 1.4.2.1 ] Filtration
[ 1.5 ] Packaging
    [ 1.5.1 ] Primary packaging
        [ 1.5.1.10 ] Radionuclide generators
[ 1.6 ] Quality control testing
    [ 1.6.1 ] Microbiological: sterility
SCOPE OF AUTHORISATION
Annex 2
Name and address of the site:

BARTS HEALTH NHS TRUST (PHARMACY CHEMOTHERAPY UNIT 7TH FLOOR), DEPARTMENT OF PHARMACY- PHARMACY CHEMOTHERAPY UNIT, 7TH FLOOR, KING GEORGE V WING, ST BARTHOLOMEW'S HOSPITAL, WEST SMITHFIELD, LONDON, EC1A 7BE, 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
    [ 1.1.2 ] Terminally Sterilised (processing operations for the following dosage forms)
        [ 1.1.2.1 ] Large volume liquids
[ 1.2 ] Non-sterile investigational medicinal products
    [ 1.2.1 ] Non-Sterile Products (processing operations for the following dosage forms)
        [ 1.2.1.5 ] Liquids for external use
        [ 1.2.1.6 ] Liquids for internal use
[ 1.3 ] Biological investigational medicinal products
    [ 1.3.1 ] Biological medicinal products
        [ 1.3.1.4 ] Gene therapy products
        [ 1.3.1.8 ] Other biological medicinal products
            Monoclonal Antibodies
[ 1.4 ] Other investigational medicinal products or manufacturing activitiy
    [ 1.4.1 ] Manufacture of:
        [ 1.4.1.3 ] Other
            Radiopharmaceuticals/radionuclide generators
[ 1.5 ] Packaging
    [ 1.5.1 ] Primary packaging
        [ 1.5.1.5 ] Liquids for external use
        [ 1.5.1.6 ] Liquids for internal use
        [ 1.5.1.11 ] Semi-solids
    [ 1.5.2 ] Secondary packaging
[ 1.6 ] Quality control testing
    [ 1.6.2 ] Microbiological: non-sterility
    [ 1.6.3 ] Chemical/Physical
SCOPE OF AUTHORISATION
Annex 2
Name and address of the site:

BARTS HEALTH NHS TRUST, PHARMACY TECHNICAL SERVICES, 1ST FLOOR PATHOLOGY & PHARMACY BUILDING, ROYAL LONDON HOSPITAL ,80 NEWARK STREET, LONDON, E1 2ES, 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
[ 1.2 ] Non-sterile investigational medicinal products
    [ 1.2.1 ] Non-Sterile Products (processing operations for the following dosage forms)
        [ 1.2.1.5 ] Liquids for external use
        [ 1.2.1.6 ] Liquids for internal use
        [ 1.2.1.11 ] Semi-solids
[ 1.3 ] Biological investigational medicinal products
    [ 1.3.1 ] Biological medicinal products
        [ 1.3.1.4 ] Gene therapy products
        [ 1.3.1.8 ] Other biological medicinal products
            Antibodies/antibody conjugates
[ 1.4 ] Other investigational medicinal products or manufacturing activitiy
    [ 1.4.2 ] Sterilisation of active substances/excipients/finished products:
        [ 1.4.2.1 ] Filtration
[ 1.5 ] Packaging
    [ 1.5.1 ] Primary packaging
        [ 1.5.1.13 ] Tablets
    [ 1.5.2 ] Secondary packaging
[ 1.6 ] Quality control testing
    [ 1.6.2 ] Microbiological: non-sterility
    [ 1.6.3 ] Chemical/Physical