Medicines and Healthcare products Regulatory Agency

MANUFACTURER'S AUTHORISATION
1: Authorisation Number UK MIA 21659
2: Name of authorisation holder VALNEVA SCOTLAND LIMITED
3: Address(es) of manufacturing site(s)

VALNEVA SCOTLAND LIMITED, OAKBANK PARK ROAD, MID CALDER, LIVINGSTON, EH53 0TG, UNITED KINGDOM

4: Legally registered address of authorisation holder VALNEVA SCOTLAND LIMITED, OAKBANK PARK ROAD, MID CALDER, LIVINGSTON, EH53 0TG, 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 12/02/2024
9: Annexes attached Annex 1 and/or Annex 2
SCOPE OF AUTHORISATION
Annex 1
Name and address of the site:

VALNEVA SCOTLAND LIMITED, OAKBANK PARK ROAD, MID CALDER, LIVINGSTON, EH53 0TG, UNITED KINGDOM

Human Medicinal Products
Authorised Operations
Authorised Operations
MANUFACTURING OPERATIONS (according to part 1)
Operations
Part 1 - MANUFACTURING OPERATIONS
[ 1.1 ] Sterile Products
    [ 1.1.1 ] Aseptically prepared (processing operations for the following dosage forms)
        [ 1.1.1.1 ] Large volume liquids
[ 1.3 ] Biological medicinal products
    [ 1.3.1 ] Biological medicinal products
        [ 1.3.1.2 ] Immunological products
    [ 1.3.2 ] Batch certification
        [ 1.3.2.2 ] Immunological products
[ 1.4 ] Other products or manufacturing activity
    [ 1.4.2 ] Sterilisation of active substances/excipients/finished products:
        [ 1.4.2.1 ] Filtration
[ 1.6 ] Quality control testing
    [ 1.6.2 ] Microbiological: non-sterility
    [ 1.6.3 ] Chemical/Physical
    [ 1.6.4 ] Biological