Medicines and Healthcare products Regulatory Agency

MANUFACTURER'S AUTHORISATION
1: Authorisation Number UK MIA(IMP) 11149
2: Name of authorisation holder ROYAL FREE LONDON NHS FOUNDATION TRUST
3: Address(es) of manufacturing site(s)

ROYAL FREE LONDON NHS FOUNDATION TRUST, RADIOPHARMACY NUCLEAR MEDICINE, THE ROYAL FREE HOSPITAL, POND STREET, LONDON, NW3 2QG, UNITED KINGDOM

ROYAL FREE LONDON NHS FOUNDATION TRUST, PHARMACY DEPARTMENT, THE ROYAL FREE HOSPITAL, POND STREET, LONDON, NW3 2QG, UNITED KINGDOM

ROYAL FREE LONDON NHS FOUNDATION TRUST, CENTRE FOR CELL, GENE & TISSUE THERAPEUTICS, POND STREET, LONDON, NW3 2QG, UNITED KINGDOM

4: Legally registered address of authorisation holder ROYAL FREE LONDON NHS FOUNDATION TRUST, PHARMACY DEPARTMENT, THE ROYAL FREE HOSPITAL, POND STREET, LONDON, NW3 2QG, 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 15/09/2021
9: Annexes attached Annex 1 and/or Annex 2
SCOPE OF AUTHORISATION
Annex 2
Name and address of the site:

ROYAL FREE LONDON NHS FOUNDATION TRUST, RADIOPHARMACY NUCLEAR MEDICINE, THE ROYAL FREE HOSPITAL, POND STREET, LONDON, NW3 2QG, 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
            Radio Pharmaceuticals
[ 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
        [ 1.3.1.6 ] Human or animal extracted products
        [ 1.3.1.8 ] Other biological medicinal products
            Proteins, Peptides
    [ 1.3.2 ] Batch certification
        [ 1.3.2.2 ] Immunological products
        [ 1.3.2.3 ] Cell therapy products
        [ 1.3.2.4 ] Gene therapy products
        [ 1.3.2.6 ] Human or animal extracted products
        [ 1.3.2.8 ] Other biological medicinal products
            Proteins, Peptides
[ 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
        [ 1.5.1.6 ] Liquids for internal use
    [ 1.5.2 ] Secondary packaging
[ 1.6 ] Quality control testing
    [ 1.6.2 ] Microbiological: non-sterility
    [ 1.6.3 ] Chemical/Physical
    [ 1.6.4 ] Biological
SCOPE OF AUTHORISATION
Annex 2
Name and address of the site:

ROYAL FREE LONDON NHS FOUNDATION TRUST, PHARMACY DEPARTMENT, THE ROYAL FREE HOSPITAL, POND STREET, LONDON, NW3 2QG, 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)
        [ 1.1.1.1 ] Large volume liquids
        [ 1.1.1.3 ] Semi-solids
        [ 1.1.1.4 ] Small volume liquids
    [ 1.1.2 ] Terminally Sterilised (processing operations for the following dosage forms)
        [ 1.1.2.1 ] Large volume liquids
        [ 1.1.2.2 ] Semi-solids
        [ 1.1.2.3 ] Small volume liquids
        [ 1.1.2.5 ] Other terminally sterilised prepared products
            Ampoules, Creams, Powders, Medicated Dressings, (sent away for sterilisation by irradiation), and Bo
    [ 1.1.3 ] Batch certification
[ 1.2 ] Non-sterile investigational medicinal products
    [ 1.2.1 ] Non-Sterile Products (processing operations for the following dosage forms)
        [ 1.2.1.1 ] Capsules, hard shell
        [ 1.2.1.5 ] Liquids for external use
        [ 1.2.1.6 ] Liquids for internal use
        [ 1.2.1.11 ] Semi-solids
        [ 1.2.1.13 ] Tablets
[ 1.3 ] Biological investigational medicinal products
    [ 1.3.1 ] Biological medicinal products
        [ 1.3.1.1 ] Blood products
        [ 1.3.1.2 ] Immunological products
        [ 1.3.1.6 ] Human or animal extracted products
        [ 1.3.1.8 ] Other biological medicinal products
            Proteins, Peptides
    [ 1.3.2 ] Batch certification
        [ 1.3.2.1 ] Blood products
        [ 1.3.2.2 ] Immunological products
        [ 1.3.2.6 ] Human or animal extracted 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
        [ 1.4.2.2 ] Dry heat
        [ 1.4.2.3 ] Moist heat
[ 1.5 ] Packaging
    [ 1.5.1 ] Primary packaging
        [ 1.5.1.1 ] Capsules, hard shell
        [ 1.5.1.2 ] Capsules, soft shell
        [ 1.5.1.5 ] Liquids for external use
        [ 1.5.1.6 ] Liquids for internal use
        [ 1.5.1.8 ] Other solid dosage forms
        [ 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
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
        [ 2.2.1.2 ] Terminally sterilised
    [ 2.2.2 ] Non-sterile products
[ 2.3 ] Other Importation Activities
    [ 2.3.1 ] Site of Physical Importation
    [ 2.3.2 ] Importation of Intermediate which undergoes further processing
SCOPE OF AUTHORISATION
Annex 2
Name and address of the site:

ROYAL FREE LONDON NHS FOUNDATION TRUST, CENTRE FOR CELL, GENE & TISSUE THERAPEUTICS, POND STREET, LONDON, NW3 2QG, 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)
        [ 1.1.1.5 ] Solids and implants
        [ 1.1.1.6 ] Other aseptically prepared products
            ATMPs
    [ 1.1.3 ] Batch certification
[ 1.3 ] Biological investigational medicinal products
    [ 1.3.1 ] Biological medicinal products
        [ 1.3.1.3 ] Cell therapy products
        [ 1.3.1.4 ] Gene therapy products
        [ 1.3.1.7 ] Tissue Engineered Products
        [ 1.3.1.8 ] Other biological medicinal products
            INTERMEDIATE MATERIALS: TISSUE CULTURE SUPERNATANTS
    [ 1.3.2 ] Batch certification
        [ 1.3.2.3 ] Cell therapy products
        [ 1.3.2.4 ] Gene therapy products
        [ 1.3.2.7 ] Tissue Engineered Products
[ 1.5 ] Packaging
    [ 1.5.2 ] Secondary packaging
[ 1.6 ] Quality control testing
    [ 1.6.1 ] Microbiological: sterility
    [ 1.6.4 ] Biological
Part 2 - IMPORTATION OF MEDICINAL PRODUCTS
[ 2.1 ] Quality control testing of imported medicinal products
    [ 2.1.1 ] Microbiological: sterility
    [ 2.1.4 ] Biological
[ 2.2 ] Batch certification of imported medicinal products
    [ 2.2.3 ] Biological medicinal products
        [ 2.2.3.3 ] Cell therapy products
        [ 2.2.3.4 ] Gene therapy products
[ 2.3 ] Other Importation Activities
    [ 2.3.2 ] Importation of Intermediate which undergoes further processing