Medicines and Healthcare products Regulatory Agency

MANUFACTURER'S AUTHORISATION
1: Authorisation Number UK MIA 6183
2: Name of authorisation holder AIR PRODUCTS PLC
3: Address(es) of manufacturing site(s)

AIR PRODUCTS PLC, MANCHESTER ROAD, CARRINGTON, MANCHESTER, M31 4TG, UNITED KINGDOM

AIR PRODUCTS PLC, HAWKSWORTH, HARRIER PARK, DIDCOT, OX11 7PL, UNITED KINGDOM

AIR PRODUCTS PLC, SALTEND LANE, HEDON, HULL, HU12 8PP, UNITED KINGDOM

AIR PRODUCTS PLC, SHARP STREET, WALKDEN, WORSLEY, MANCHESTER, M28 3WA, UNITED KINGDOM

AIR PRODUCTS PLC, 2 MILLENNIUM GATE, WESTMERE DRIVE, CREWE, CW1 6AP, UNITED KINGDOM

4: Legally registered address of authorisation holder AIR PRODUCTS PLC, 2 MILLENNIUM GATE, WESTMERE DRIVE, CREWE, CHESHIRE, CW1 6AP, 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 01/03/2021
9: Annexes attached Annex 1 and/or Annex 2
SCOPE OF AUTHORISATION
Annex 1
Name and address of the site:

AIR PRODUCTS PLC, MANCHESTER ROAD, CARRINGTON, MANCHESTER, M31 4TG, UNITED KINGDOM

Human Medicinal Products
Authorised Operations
Authorised Operations
MANUFACTURING OPERATIONS (according to part 1)
Operations
Part 1 - MANUFACTURING OPERATIONS
[ 1.2 ] Non-sterile products
    [ 1.2.1 ] Non-Sterile Products (processing operations for the following dosage forms)
        [ 1.2.1.7 ] Medicinal gases
[ 1.5 ] Packaging
    [ 1.5.1 ] Primary packaging
        [ 1.5.1.7 ] Medicinal gases
[ 1.6 ] Quality control testing
    [ 1.6.3 ] Chemical/Physical
SCOPE OF AUTHORISATION
Annex 1
Name and address of the site:

AIR PRODUCTS PLC, HAWKSWORTH, HARRIER PARK, DIDCOT, OX11 7PL, UNITED KINGDOM

Human Medicinal Products
Authorised Operations
Authorised Operations
MANUFACTURING OPERATIONS (according to part 1)
Operations
Part 1 - MANUFACTURING OPERATIONS
[ 1.2 ] Non-sterile products
    [ 1.2.1 ] Non-Sterile Products (processing operations for the following dosage forms)
        [ 1.2.1.7 ] Medicinal gases
[ 1.5 ] Packaging
    [ 1.5.1 ] Primary packaging
        [ 1.5.1.7 ] Medicinal gases
[ 1.6 ] Quality control testing
    [ 1.6.3 ] Chemical/Physical
SCOPE OF AUTHORISATION
Annex 1
Name and address of the site:

AIR PRODUCTS PLC, SALTEND LANE, HEDON, HULL, HU12 8PP, UNITED KINGDOM

Human Medicinal Products
Authorised Operations
Authorised Operations
MANUFACTURING OPERATIONS (according to part 1)
Operations
Part 1 - MANUFACTURING OPERATIONS
[ 1.2 ] Non-sterile products
    [ 1.2.1 ] Non-Sterile Products (processing operations for the following dosage forms)
        [ 1.2.1.7 ] Medicinal gases
[ 1.5 ] Packaging
    [ 1.5.1 ] Primary packaging
        [ 1.5.1.7 ] Medicinal gases
[ 1.6 ] Quality control testing
    [ 1.6.3 ] Chemical/Physical
SCOPE OF AUTHORISATION
Annex 1
Name and address of the site:

AIR PRODUCTS PLC, SHARP STREET, WALKDEN, WORSLEY, MANCHESTER, M28 3WA, UNITED KINGDOM

Human Medicinal Products
Authorised Operations
Authorised Operations
MANUFACTURING OPERATIONS (according to part 1)
Operations
Part 1 - MANUFACTURING OPERATIONS
[ 1.2 ] Non-sterile products
    [ 1.2.1 ] Non-Sterile Products (processing operations for the following dosage forms)
        [ 1.2.1.7 ] Medicinal gases
[ 1.5 ] Packaging
    [ 1.5.1 ] Primary packaging
        [ 1.5.1.7 ] Medicinal gases
[ 1.6 ] Quality control testing
    [ 1.6.3 ] Chemical/Physical
SCOPE OF AUTHORISATION
Annex 1
Name and address of the site:

AIR PRODUCTS PLC, 2 MILLENNIUM GATE, WESTMERE DRIVE, CREWE, CW1 6AP, UNITED KINGDOM

Human Medicinal Products
Authorised Operations
Authorised Operations
MANUFACTURING OPERATIONS (according to part 1)
Operations
Part 1 - MANUFACTURING OPERATIONS
[ 1.2 ] Non-sterile products
    [ 1.2.1 ] Non-Sterile Products (processing operations for the following dosage forms)
        [ 1.2.1.7 ] Medicinal gases
    [ 1.2.2 ] Batch certification
[ 1.5 ] Packaging
    [ 1.5.1 ] Primary packaging
        [ 1.5.1.7 ] Medicinal gases
[ 1.6 ] Quality control testing
    [ 1.6.3 ] Chemical/Physical