Medicines and Healthcare products Regulatory Agency

MANUFACTURER'S AUTHORISATION
1: Authorisation Number UK MIA(IMP) 19054
2: Name of authorisation holder ALIUM MEDICAL LIMITED
3: Address(es) of manufacturing site(s)

ALIUM MEDICAL LIMITED, UNIT 7, CAPITAL BUSINESS PARK, MANOR WAY, BOREHAMWOOD, WD6 1GW, UNITED KINGDOM

4: Legally registered address of authorisation holder ALIUM MEDICAL LIMITED, UNIT 7, CAPITAL BUSINESS PARK, MANOR WAY, BOREHAMWOOD, WD6 1GW, 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 13/07/2022
9: Annexes attached Annex 1 and/or Annex 2
SCOPE OF AUTHORISATION
Annex 2
Name and address of the site:

ALIUM MEDICAL LIMITED, UNIT 7, CAPITAL BUSINESS PARK, MANOR WAY, BOREHAMWOOD, WD6 1GW, UNITED KINGDOM

Human Investigational Medicinal Products
Authorised Operations
Authorised Operations
IMPORTATION OF MEDICINAL PRODUCTS (according to part 2)
Operations
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
    [ 2.2.2 ] Non-sterile products
[ 2.3 ] Other Importation Activities
    [ 2.3.1 ] Site of Physical Importation
    [ 2.3.2 ] Importation of Intermediate which undergoes further processing