Medicines and Healthcare products Regulatory Agency

MANUFACTURER'S AUTHORISATION
1: Authorisation Number UK MIA 1811
2: Name of authorisation holder BARD PHARMACEUTICALS LIMITED
3: Address(es) of manufacturing site(s)

BARD PHARMACEUTICALS LIMITED, UNIT 191, CAMBRIDGE SCIENCE PARK, MILTON ROAD, CAMBRIDGE, CB4 0GW, UNITED KINGDOM

4: Legally registered address of authorisation holder BARD PHARMACEUTICALS LIMITED, UNIT 198, CAMBRIDGE SCIENCE PARK, MILTON ROAD, CAMBRIDGE, CB4 0AB, 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 15/03/2023
9: Annexes attached Annex 1 and/or Annex 2
SCOPE OF AUTHORISATION
Annex 1
Name and address of the site:

BARD PHARMACEUTICALS LIMITED, UNIT 191, CAMBRIDGE SCIENCE PARK, MILTON ROAD, CAMBRIDGE, CB4 0GW, UNITED KINGDOM

Human Medicinal Products
Authorised Operations
Authorised Operations
MANUFACTURING OPERATIONS (according to part 1)
IMPORTATION OF MEDICINAL PRODUCTS (according to part 2)
Operations
Part 1 - MANUFACTURING OPERATIONS
[ 1.1 ] Sterile Products
    [ 1.1.3 ] Batch certification
[ 1.2 ] Non-sterile products
    [ 1.2.1 ] Non-Sterile Products (processing operations for the following dosage forms)
        [ 1.2.1.1 ] Capsules, hard shell
        [ 1.2.1.13 ] Tablets
        [ 1.2.1.17 ] Other non-sterile medicinal products
            Granules for suspension.
    [ 1.2.2 ] Batch certification
[ 1.5 ] Packaging
    [ 1.5.1 ] Primary packaging
        [ 1.5.1.1 ] Capsules, hard shell
        [ 1.5.1.13 ] Tablets
        [ 1.5.1.17 ] Other non-sterile medicinal products
            Granules for suspension
    [ 1.5.2 ] Secondary packaging
[ 1.6 ] Quality control testing
    [ 1.6.3 ] Chemical/Physical
Part 2 - IMPORTATION OF MEDICINAL PRODUCTS
[ 2.1 ] Quality control testing of imported medicinal products
    [ 2.1.3 ] Chemical/Physical
[ 2.2 ] Batch certification of imported medicinal products
    [ 2.2.1 ] Sterile Products
        [ 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