Medicines and Healthcare products Regulatory Agency

MANUFACTURER'S AUTHORISATION
1: Authorisation Number UK MIA 16363
2: Name of authorisation holder MILPHARM LIMITED
3: Address(es) of manufacturing site(s)

MILPHARM LIMITED, ARES BLOCK, ODYSSEY BUSINESS PARK, WEST END ROAD, RUISLIP, HA4 6QD, UNITED KINGDOM

4: Legally registered address of authorisation holder MILPHARM LIMITED, ARES BLOCK, ODYSSEY BUSINESS PARK, WEST END ROAD, RUISLIP, HA4 6QD, 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 17/06/2024
9: Annexes attached Annex 1 and/or Annex 2
SCOPE OF AUTHORISATION
Annex 1
Name and address of the site:

MILPHARM LIMITED, ARES BLOCK, ODYSSEY BUSINESS PARK, WEST END ROAD, RUISLIP, HA4 6QD, UNITED KINGDOM

Human 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