Medicines and Healthcare products Regulatory Agency

MANUFACTURER'S AUTHORISATION
1: Authorisation Number UK MIA(IMP) 57419
2: Name of authorisation holder EMERGEX VACCINES HOLDING LIMITED
3: Address(es) of manufacturing site(s)

EMERGEX VACCINES HOLDING LIMITED, 65 INNOVATION DRIVE, MILTON PARK, MILTON, ABINGDON, OX14 4RQ, UNITED KINGDOM

4: Legally registered address of authorisation holder EMERGEX VACCINES HOLDING LIMITED, 65 INNOVATION DRIVE, MILTON PARK, MILTON, ABINGDON, OX14 4RQ, 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 21/06/2024
9: Annexes attached Annex 1 and/or Annex 2
SCOPE OF AUTHORISATION
Annex 2
Name and address of the site:

EMERGEX VACCINES HOLDING LIMITED, 65 INNOVATION DRIVE, MILTON PARK, MILTON, ABINGDON, OX14 4RQ, 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
[ 1.2 ] Non-sterile investigational medicinal products
    [ 1.2.1 ] Non-Sterile Products (processing operations for the following dosage forms)
        [ 1.2.1.6 ] Liquids for internal use
[ 1.5 ] Packaging
    [ 1.5.1 ] Primary packaging
        [ 1.5.1.6 ] Liquids for internal use
[ 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
[ 2.3 ] Other Importation Activities
    [ 2.3.2 ] Importation of Intermediate which undergoes further processing