Medicines and Healthcare products Regulatory Agency

MANUFACTURER'S AUTHORISATION
1: Authorisation Number UK MIA(IMP) 19819
2: Name of authorisation holder BIOTEC SERVICES INTERNATIONAL LIMITED
3: Address(es) of manufacturing site(s)

BIOTEC SERVICES INTERNATIONAL LIMITED, UNITS 2100, 2110, 2120, 2130, 2010, 2430 AND 2500, PHASE 18, CENTRAL PARK, BRIDGEND INDUSTRIAL ESTATE, BRIDGEND, CF31 3TY, UNITED KINGDOM

BIOTEC SERVICES INTERNATIONAL LIMITED, BIOTEC HOUSE, CENTRAL PARK, WESTERN AVENUE, BRIDGEND INDUSTRIAL ESTATE, BRIDGEND, CF31 3RT, UNITED KINGDOM

4: Legally registered address of authorisation holder BIOTEC SERVICES INTERNATIONAL LIMITED, BIOTEC HOUSE, CENTRAL PARK, WESTERN AVENUE, BRIDGEND INDUSTRIAL ESTATE, BRIDGEND, CF31 3RT, 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 01/05/2024
9: Annexes attached Annex 1 and/or Annex 2
SCOPE OF AUTHORISATION
Annex 2
Name and address of the site:

BIOTEC SERVICES INTERNATIONAL LIMITED, UNITS 2100, 2110, 2120, 2130, 2010, 2430 AND 2500, PHASE 18, CENTRAL PARK, BRIDGEND INDUSTRIAL ESTATE, BRIDGEND, CF31 3TY, 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
    [ 1.1.3 ] Batch certification
[ 1.2 ] Non-sterile investigational medicinal products
    [ 1.2.2 ] Batch certification
[ 1.3 ] Biological investigational medicinal products
    [ 1.3.2 ] Batch certification
        [ 1.3.2.1 ] Blood products
        [ 1.3.2.2 ] Immunological products
        [ 1.3.2.3 ] Cell therapy products
        [ 1.3.2.4 ] Gene therapy products
        [ 1.3.2.5 ] Biotechnology products
        [ 1.3.2.6 ] Human or animal extracted products
        [ 1.3.2.7 ] Tissue Engineered Products
[ 1.5 ] Packaging
    [ 1.5.2 ] Secondary packaging
Part 2 - IMPORTATION OF MEDICINAL PRODUCTS
[ 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
    [ 2.2.3 ] Biological medicinal products
        [ 2.2.3.1 ] Blood products
        [ 2.2.3.2 ] Immunological products
        [ 2.2.3.3 ] Cell therapy products
        [ 2.2.3.4 ] Gene therapy products
        [ 2.2.3.5 ] Biotechnology products
        [ 2.2.3.6 ] Human or animal extracted products
        [ 2.2.3.7 ] Tissue Engineered Products
        [ 2.2.3.8 ] Other biological medicinal products
            Tissue engineered products
[ 2.3 ] Other Importation Activities
    [ 2.3.1 ] Site of Physical Importation
    [ 2.3.2 ] Importation of Intermediate which undergoes further processing
    [ 2.3.4 ] Other
        Importation of QP certified IMPs from a country on the approved country for import list
SCOPE OF AUTHORISATION
Annex 2
Name and address of the site:

BIOTEC SERVICES INTERNATIONAL LIMITED, BIOTEC HOUSE, CENTRAL PARK, WESTERN AVENUE, BRIDGEND INDUSTRIAL ESTATE, BRIDGEND, CF31 3RT, 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
    [ 1.1.3 ] Batch certification
[ 1.2 ] Non-sterile investigational medicinal products
    [ 1.2.2 ] Batch certification
[ 1.3 ] Biological investigational medicinal products
    [ 1.3.2 ] Batch certification
        [ 1.3.2.1 ] Blood products
        [ 1.3.2.2 ] Immunological products
        [ 1.3.2.3 ] Cell therapy products
        [ 1.3.2.4 ] Gene therapy products
        [ 1.3.2.5 ] Biotechnology products
        [ 1.3.2.6 ] Human or animal extracted products
        [ 1.3.2.7 ] Tissue Engineered Products
[ 1.5 ] Packaging
    [ 1.5.2 ] Secondary packaging
Part 2 - IMPORTATION OF MEDICINAL PRODUCTS
[ 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
    [ 2.2.3 ] Biological medicinal products
        [ 2.2.3.1 ] Blood products
        [ 2.2.3.2 ] Immunological products
        [ 2.2.3.3 ] Cell therapy products
        [ 2.2.3.4 ] Gene therapy products
        [ 2.2.3.5 ] Biotechnology products
        [ 2.2.3.6 ] Human or animal extracted products
        [ 2.2.3.7 ] Tissue Engineered Products
        [ 2.2.3.8 ] Other biological medicinal products
            Tissue engineered products
[ 2.3 ] Other Importation Activities
    [ 2.3.1 ] Site of Physical Importation
    [ 2.3.2 ] Importation of Intermediate which undergoes further processing
    [ 2.3.4 ] Other
        Importation of QP certified IMPs from a country on the approved country for import list