Medicines and Healthcare products Regulatory Agency

MANUFACTURER'S AUTHORISATION
1: Authorisation Number UK MIA(IMP) 22443
2: Name of authorisation holder ALLIANCE MEDICAL RADIOPHARMACY LIMITED
3: Address(es) of manufacturing site(s)

ALLIANCE MEDICAL RADIOPHARMACY LIMITED , ROYAL MARSDEN HOSPITAL, DOWNS ROAD, SUTTON, SM2 5PT, UNITED KINGDOM

4: Legally registered address of authorisation holder ALLIANCE MEDICAL RADIOPHARMACY LIMITED, ICENI CENTRE, WARWICK TECHNOLOGY PARK, GALLOWS HILL, WARWICK, CV34 6DA, 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 25/11/2021
9: Annexes attached Annex 1 and/or Annex 2
SCOPE OF AUTHORISATION
Annex 2
Name and address of the site:

ALLIANCE MEDICAL RADIOPHARMACY LIMITED , ROYAL MARSDEN HOSPITAL, DOWNS ROAD, SUTTON, SM2 5PT, UNITED KINGDOM

Human Investigational Medicinal Products
Authorised Operations
Authorised Operations
MANUFACTURING OPERATIONS (according to part 1)
Operations
Part 1 - MANUFACTURING OPERATIONS
[ 1.1 ] Sterile Investigational Medicinal Products
    [ 1.1.1 ] Aseptically prepared (processing operations for the following dosage forms)
        [ 1.1.1.4 ] Small volume liquids
        [ 1.1.1.6 ] Other aseptically prepared products
            Radiopharmaceuticals (small volume liquids)
    [ 1.1.2 ] Terminally Sterilised (processing operations for the following dosage forms)
        [ 1.1.2.3 ] Small volume liquids
        [ 1.1.2.5 ] Other terminally sterilised prepared products
            Radiopharmaceuticals (small volume liquids)
    [ 1.1.3 ] Batch certification
[ 1.4 ] Other investigational medicinal products or manufacturing activitiy
    [ 1.4.2 ] Sterilisation of active substances/excipients/finished products:
        [ 1.4.2.1 ] Filtration
        [ 1.4.2.3 ] Moist heat
[ 1.5 ] Packaging
    [ 1.5.1 ] Primary packaging
        [ 1.5.1.6 ] Liquids for internal use
    [ 1.5.2 ] Secondary packaging
[ 1.6 ] Quality control testing
    [ 1.6.2 ] Microbiological: non-sterility
    [ 1.6.3 ] Chemical/Physical