Medicines and Healthcare products Regulatory Agency

MANUFACTURER'S AUTHORISATION
1: Authorisation Number UK MIA 45803
2: Name of authorisation holder ROSLIN CELL THERAPIES LIMITED
3: Address(es) of manufacturing site(s)

ROSLINCT - SHAWFAIR, 2 WESTER SHAWFAIR, DANDERHALL, DALKEITH, EH22 1FD, UNITED KINGDOM

BIO CUBE 2, BIOCUBE 2, 11 LITTLE FRANCE ROAD, EDINBURGH BIOQUARTER, EDINBURGH, EH16 4UX, UNITED KINGDOM

4: Legally registered address of authorisation holder ROSLIN CELL THERAPIES LIMITED, 9 LITTLE FRANCE ROAD, EDINBURGH BIOQUARTER, EDINBURGH, EH16 4UX, 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 20/05/2024
9: Annexes attached Annex 1 and/or Annex 2
SCOPE OF AUTHORISATION
Annex 1
Name and address of the site:

ROSLINCT - SHAWFAIR, 2 WESTER SHAWFAIR, DANDERHALL, DALKEITH, EH22 1FD, UNITED KINGDOM

Human Medicinal Products
Authorised Operations
Authorised Operations
MANUFACTURING OPERATIONS (according to part 1)
Operations
Part 1 - MANUFACTURING OPERATIONS
[ 1.1 ] Sterile Products
    [ 1.1.3 ] Batch certification
[ 1.3 ] Biological medicinal products
    [ 1.3.2 ] Batch certification
        [ 1.3.2.3 ] Cell therapy products
            Special Requirements
            Live Cells
        [ 1.3.2.4 ] Gene therapy products
            Special Requirements
            Live Cells
        [ 1.3.2.6 ] Human or animal extracted products
            Special Requirements
            Live Cells
SCOPE OF AUTHORISATION
Annex 1
Name and address of the site:

BIO CUBE 2, BIOCUBE 2, 11 LITTLE FRANCE ROAD, EDINBURGH BIOQUARTER, EDINBURGH, EH16 4UX, UNITED KINGDOM

Human Medicinal Products
Authorised Operations
Authorised Operations
MANUFACTURING OPERATIONS (according to part 1)
Operations
Part 1 - MANUFACTURING OPERATIONS
[ 1.1 ] Sterile Products
    [ 1.1.1 ] Aseptically prepared (processing operations for the following dosage forms)
        [ 1.1.1.6 ] Other aseptically prepared products
            Cellular therapy products ( ATMPs), Master cell banks
            Special Requirements
            Live Cells
    [ 1.1.3 ] Batch certification
[ 1.3 ] Biological medicinal products
    [ 1.3.1 ] Biological medicinal products
        [ 1.3.1.3 ] Cell therapy products
            Special Requirements
            Live Cells
        [ 1.3.1.4 ] Gene therapy products
            Special Requirements
            Live Cells
        [ 1.3.1.6 ] Human or animal extracted products
            Special Requirements
            Live Cells
        [ 1.3.1.7 ] Tissue Engineered Products
            Special Requirements
            Live Cells
    [ 1.3.2 ] Batch certification
        [ 1.3.2.3 ] Cell therapy products
            Special Requirements
            Live Cells
        [ 1.3.2.4 ] Gene therapy products
            Special Requirements
            Live Cells
        [ 1.3.2.6 ] Human or animal extracted products
            Special Requirements
            Live Cells
        [ 1.3.2.7 ] Tissue Engineered Products
            Special Requirements
            Live Cells
[ 1.5 ] Packaging
    [ 1.5.1 ] Primary packaging
        [ 1.5.1.6 ] Liquids for internal use
    [ 1.5.2 ] Secondary packaging