Medicines and Healthcare products Regulatory Agency

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

BIO CUBE 2, NINE EDINBURGH BIO QUARTER, 9 LITTLE FRANCE ROAD, EDINBURGH, EH16 4UX, UNITED KINGDOM

SCOTTISH CENTRE FOR REGENERATIVE MEDICINE, GMP CELLULAR THERAPY FACILITY, SCOTTISH CENTRE FOR REGENERATIVE MEDICINE, EDINBURGH BIOQUARTER, 5 LITTLE FRANCE DRIVE, EDINBURGH, EH16 4UU, UNITED KINGDOM

4: Legally registered address of authorisation holder ROSLIN CELL THERAPIES LIMITED, NINE EDINBURGH BIO QUARTER, 9 LITTLE FRANCE ROAD, 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 19/10/2021
9: Annexes attached Annex 1 and/or Annex 2
SCOPE OF AUTHORISATION
Annex 2
Name and address of the site:

BIO CUBE 2, NINE EDINBURGH BIO QUARTER, 9 LITTLE FRANCE ROAD, EDINBURGH, EH16 4UX, 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
[ 1.3 ] Biological investigational 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
[ 1.5 ] Packaging
    [ 1.5.1 ] Primary packaging
        [ 1.5.1.6 ] Liquids for internal use
    [ 1.5.2 ] Secondary packaging
SCOPE OF AUTHORISATION
Annex 2
Name and address of the site:

SCOTTISH CENTRE FOR REGENERATIVE MEDICINE, GMP CELLULAR THERAPY FACILITY, SCOTTISH CENTRE FOR REGENERATIVE MEDICINE, EDINBURGH BIOQUARTER, 5 LITTLE FRANCE DRIVE, EDINBURGH, EH16 4UU, 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)
        [ 1.1.1.4 ] Small volume liquids
        [ 1.1.1.6 ] Other aseptically prepared products
            cellular therapy products (ATMPS), Master cell banks
    [ 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
        [ 1.3.1.6 ] Human or animal extracted products
        [ 1.3.1.7 ] Tissue Engineered Products
            Special Requirements
            Live Cells
    [ 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
            Special Requirements
            Live Cells
[ 1.5 ] Packaging
    [ 1.5.2 ] Secondary packaging
[ 1.6 ] Quality control testing
    [ 1.6.2 ] Microbiological: non-sterility
    [ 1.6.4 ] Biological
Part 2 - IMPORTATION OF MEDICINAL PRODUCTS
[ 2.2 ] Batch certification of imported medicinal products
    [ 2.2.3 ] Biological medicinal products
        [ 2.2.3.4 ] Gene therapy products
        [ 2.2.3.7 ] Tissue Engineered Products