Medicines and Healthcare products Regulatory Agency

MANUFACTURER'S AUTHORISATION
1: Authorisation Number UK MIA 25298
2: Name of authorisation holder BROWN & BURK UK LIMITED
3: Address(es) of manufacturing site(s)

BROWN AND BURK UK LIMITED, MICRO HOUSE, BURY STREET, RUISLIP, HA4 7TL, UNITED KINGDOM

BROWN & BURK UK LIMITED, MICRO HOUSE, 5 MARRYAT CLOSE, HOUNSLOW, TW4 5DQ, UNITED KINGDOM

4: Legally registered address of authorisation holder BROWN & BURK UK LIMITED, MICRO HOUSE, 5 MARRYAT CLOSE, HOUNSLOW, TW4 5DQ, 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 06/06/2024
9: Annexes attached Annex 1 and/or Annex 2
SCOPE OF AUTHORISATION
Annex 1
Name and address of the site:

BROWN AND BURK UK LIMITED, MICRO HOUSE, BURY STREET, RUISLIP, HA4 7TL, 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
[ 2.3 ] Other Importation Activities
    [ 2.3.1 ] Site of Physical Importation
SCOPE OF AUTHORISATION
Annex 1
Name and address of the site:

BROWN & BURK UK LIMITED, MICRO HOUSE, 5 MARRYAT CLOSE, HOUNSLOW, TW4 5DQ, 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