Medicines and Healthcare products Regulatory Agency

MANUFACTURER'S AUTHORISATION
1: Authorisation Number UK MIA 17872
2: Name of authorisation holder MEDICAL GAS SOLUTIONS LIMITED
3: Address(es) of manufacturing site(s)

MEDICAL GAS SOLUTIONS LIMITED, BUILDINGS 17-22, MANOR INDUSTRIAL ESTATE, BAGILLT, CH6 5UY, UNITED KINGDOM

MEDICAL GAS SOLUTIONS LIMITED, UNIT 10 WATLING STREET BUSINESS PARK, WATLING STREET, CANNOCK, WS11 9XG, UNITED KINGDOM

4: Legally registered address of authorisation holder MEDICAL GAS SOLUTIONS LIMITED, UNIT 17-22, MANOR INDUSTRIAL ESTATE, BAGILLT, CH6 5UY, 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 31/01/2024
9: Annexes attached Annex 1 and/or Annex 2
SCOPE OF AUTHORISATION
Annex 1
Name and address of the site:

MEDICAL GAS SOLUTIONS LIMITED, BUILDINGS 17-22, MANOR INDUSTRIAL ESTATE, BAGILLT, CH6 5UY, 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
SCOPE OF AUTHORISATION
Annex 1
Name and address of the site:

MEDICAL GAS SOLUTIONS LIMITED, UNIT 10 WATLING STREET BUSINESS PARK, WATLING STREET, CANNOCK, WS11 9XG, 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