Medicines and Healthcare products Regulatory Agency

MANUFACTURER'S AUTHORISATION
1: Authorisation Number UK MIA(IMP) 13101
2: Name of authorisation holder LABCORP CLINICAL RESEARCH UNIT LIMITED
3: Address(es) of manufacturing site(s)

LABCORP CLINICAL RESEARCH UNIT LIMITED, SPRINGFIELD HOUSE, HYDE STREET, LEEDS, LS2 9LH, UNITED KINGDOM

4: Legally registered address of authorisation holder LABCORP CLINICAL RESEARCH UNIT LIMITED, SPRINGFIELD HOUSE, HYDE STREET, LEEDS, LS2 9LH, 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 25/10/2021
9: Annexes attached Annex 1 and/or Annex 2
SCOPE OF AUTHORISATION
Annex 2
Name and address of the site:

LABCORP CLINICAL RESEARCH UNIT LIMITED, SPRINGFIELD HOUSE, HYDE STREET, LEEDS, LS2 9LH, 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
        [ 1.1.1.4 ] Small volume liquids
        [ 1.1.1.6 ] Other aseptically prepared products
            Formulation/Reconstitution of biologicals and peptide hormones with subsequent manufacture of small
[ 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
        [ 1.2.1.8 ] Other solid dosage forms
        [ 1.2.1.15 ] Other non-sterile medicinal products
            Radiolabelled substances e.g. liquids, solid dosage forms and capsules
[ 1.3 ] Biological investigational medicinal products
    [ 1.3.1 ] Biological medicinal products
        [ 1.3.1.8 ] Other biological medicinal products
            Packaging of immunological and biotechnology products. Packaging of human or animal extracted produc
[ 1.4 ] Other investigational medicinal products or manufacturing activitiy
    [ 1.4.1 ] Manufacture of:
        [ 1.4.1.3 ] Other
            Radiolabelled substances e.g. e.g. liquid and solid dosage forms.
    [ 1.4.2 ] Sterilisation of active substances/excipients/finished products:
        [ 1.4.2.1 ] Filtration
[ 1.5 ] Packaging
    [ 1.5.1 ] Primary packaging
        [ 1.5.1.1 ] Capsules, hard shell
        [ 1.5.1.2 ] Capsules, soft shell
        [ 1.5.1.3 ] Chewing gums
        [ 1.5.1.4 ] Impregnated matrices
        [ 1.5.1.5 ] Liquids for external use
        [ 1.5.1.6 ] Liquids for internal use
        [ 1.5.1.8 ] Other solid dosage forms
        [ 1.5.1.11 ] Semi-solids
        [ 1.5.1.12 ] Suppositories
        [ 1.5.1.13 ] Tablets
        [ 1.5.1.14 ] Transdermal patches
    [ 1.5.2 ] Secondary packaging
[ 1.6 ] Quality control testing
    [ 1.6.3 ] Chemical/Physical
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
        [ 2.2.3.2 ] Immunological products
        [ 2.2.3.5 ] Biotechnology products
        [ 2.2.3.6 ] Human or animal extracted products
[ 2.3 ] Other Importation Activities
    [ 2.3.1 ] Site of Physical Importation