Medicines and Healthcare products Regulatory Agency

MANUFACTURER'S AUTHORISATION
1: Authorisation Number UK MIA 3076
2: Name of authorisation holder SPECIALITY OXYGEN SERVICE LIMITED
3: Address(es) of manufacturing site(s)

SPECIALITY OXYGEN SERVICE LIMITED, CONWAY INDUSTRIAL ESTATE, SKULL HOUSE LANE, APPLEY BRIDGE, WIGAN, WN6 9DW, UNITED KINGDOM

4: Legally registered address of authorisation holder SPECIALITY OXYGEN SERVICE LIMITED, CONWAY INDUSTRIAL ESTATE, SKULL HOUSE LANE, APPLEY BRIDGE, WIGAN, WN6 9DW, 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 18/07/2022
9: Annexes attached Annex 1 and/or Annex 2
SCOPE OF AUTHORISATION
Annex 1
Name and address of the site:

SPECIALITY OXYGEN SERVICE LIMITED, CONWAY INDUSTRIAL ESTATE, SKULL HOUSE LANE, APPLEY BRIDGE, WIGAN, WN6 9DW, 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
        [ 1.2.1.9 ] Pressurised preparations
    [ 1.2.2 ] Batch certification
[ 1.5 ] Packaging
    [ 1.5.1 ] Primary packaging
        [ 1.5.1.7 ] Medicinal gases
        [ 1.5.1.9 ] Pressurised preparations
[ 1.6 ] Quality control testing
    [ 1.6.3 ] Chemical/Physical