Medicines and Healthcare products Regulatory Agency

MANUFACTURER'S AUTHORISATION
1: Authorisation Number UK MIA 57623
2: Name of authorisation holder CHARLES RIVER DISCOVERY RESEARCH SERVICES UK LIMITED
3: Address(es) of manufacturing site(s)

CHARLES RIVER DISCOVERY RESEARCH SERVICES UK LIMITED, STEPHENSON BUILDING, THE SCIENCE PARK, KEELE, NEWCASTLE, ST5 5SP, UNITED KINGDOM

4: Legally registered address of authorisation holder CHARLES RIVER DISCOVERY RESEARCH SERVICES UK LIMITED, STEPHENSON BUILDING, THE SCIENCE PARK, KEELE, NEWCASTLE, ST5 5SP, 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 24/05/2024
9: Annexes attached Annex 1 and/or Annex 2
SCOPE OF AUTHORISATION
Annex 1
Name and address of the site:

CHARLES RIVER DISCOVERY RESEARCH SERVICES UK LIMITED, STEPHENSON BUILDING, THE SCIENCE PARK, KEELE, NEWCASTLE, ST5 5SP, UNITED KINGDOM

Human 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 Products
    [ 1.1.1 ] Aseptically prepared (processing operations for the following dosage forms)
        [ 1.1.1.4 ] Small volume liquids
            Special Requirements
            Pathogenic Organisms (Biosafety Level 3 or 4)
[ 1.2 ] Non-sterile products
    [ 1.2.1 ] Non-Sterile Products (processing operations for the following dosage forms)
        [ 1.2.1.6 ] Liquids for internal use
            Special Requirements
            Live Cells
        [ 1.2.1.17 ] Other non-sterile medicinal products
            Manufacture of low bioburden bulk drug substance solutions
            Special Requirements
            Live Cells
[ 1.3 ] Biological medicinal products
    [ 1.3.1 ] Biological medicinal products
        [ 1.3.1.2 ] Immunological products
            Special Requirements
            Live Cells
        [ 1.3.1.4 ] Gene therapy products
            Special Requirements
            Live Cells
        [ 1.3.1.5 ] Biotechnology products
            Special Requirements
            Live Cells
        [ 1.3.1.8 ] Other biological medicinal products
            Antibodies,Antibody conjugates, Live microbial products, Therapeutic Virus, Plant extracted materials
            Special Requirements
            Live Cells
    [ 1.3.2 ] Batch certification
        [ 1.3.2.2 ] Immunological products
            Special Requirements
            Live Cells
        [ 1.3.2.4 ] Gene therapy products
            Special Requirements
            Live Cells
        [ 1.3.2.5 ] Biotechnology products
            Special Requirements
            Live Cells
[ 1.4 ] Other products or manufacturing activity
    [ 1.4.2 ] Sterilisation of active substances/excipients/finished products:
        [ 1.4.2.1 ] Filtration
        [ 1.4.2.3 ] Moist heat
[ 1.6 ] Quality control testing
    [ 1.6.2 ] Microbiological: non-sterility
    [ 1.6.3 ] Chemical/Physical
    [ 1.6.4 ] Biological
Part 2 - IMPORTATION OF MEDICINAL PRODUCTS
[ 2.1 ] Quality control testing of imported medicinal products
    [ 2.1.2 ] Microbiological: non-sterility
    [ 2.1.3 ] Chemical/Physical
    [ 2.1.4 ] Biological
[ 2.3 ] Other Importation Activities
    [ 2.3.1 ] Site of Physical Importation
    [ 2.3.2 ] Importation of Intermediate which undergoes further processing