Medicines and Healthcare products Regulatory Agency

MANUFACTURER'S AUTHORISATION
1: Authorisation Number UK MIA(IMP) 15059
2: Name of authorisation holder CELERION GB LIMITED
3: Address(es) of manufacturing site(s)

CELERION GB LIMITED, 22-24 LISBURN ROAD, BELFAST, BT9 6AD, UNITED KINGDOM

4: Legally registered address of authorisation holder CELERION GB LIMITED, 22-24 LISBURN ROAD, BELFAST, BT9 6AD, 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 31/01/2024
9: Annexes attached Annex 1 and/or Annex 2
SCOPE OF AUTHORISATION
Annex 2
Name and address of the site:

CELERION GB LIMITED, 22-24 LISBURN ROAD, BELFAST, BT9 6AD, UNITED KINGDOM

Human Investigational 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 Investigational Medicinal Products
    [ 1.1.1 ] Aseptically prepared (processing operations for the following dosage forms)
        [ 1.1.1.1 ] Large volume liquids
        [ 1.1.1.4 ] Small volume liquids
    [ 1.1.3 ] Batch certification
[ 1.2 ] Non-sterile investigational medicinal products
    [ 1.2.1 ] Non-Sterile Products (processing operations for the following dosage forms)
        [ 1.2.1.1 ] Capsules, hard shell
        [ 1.2.1.6 ] Liquids for internal use
    [ 1.2.2 ] Batch certification
[ 1.3 ] Biological investigational medicinal products
    [ 1.3.1 ] Biological medicinal products
        [ 1.3.1.1 ] Blood products
        [ 1.3.1.2 ] Immunological products
        [ 1.3.1.3 ] Cell therapy products
        [ 1.3.1.4 ] Gene therapy products
        [ 1.3.1.5 ] Biotechnology products
        [ 1.3.1.6 ] Human or animal extracted products
[ 1.5 ] Packaging
    [ 1.5.1 ] Primary packaging
        [ 1.5.1.1 ] Capsules, hard shell
        [ 1.5.1.2 ] Capsules, soft shell
        [ 1.5.1.3 ] Chewing gums
        [ 1.5.1.4 ] Impregnated matrices
        [ 1.5.1.5 ] Liquids for external use
        [ 1.5.1.6 ] Liquids for internal use
        [ 1.5.1.8 ] Other solid dosage forms
        [ 1.5.1.11 ] Semi-solids
        [ 1.5.1.12 ] Suppositories
        [ 1.5.1.13 ] Tablets
        [ 1.5.1.14 ] Transdermal patches
        [ 1.5.1.15 ] Other non-sterile medicinal products
            Pessaries and vaginal rings
    [ 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
        [ 2.2.1.1 ] 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