Medicines and Healthcare products Regulatory Agency

MANUFACTURER'S AUTHORISATION
1: Authorisation Number UK MIA(IMP) 29826
2: Name of authorisation holder PHARMACEUTICAL SOLUTIONS LIMITED
3: Address(es) of manufacturing site(s)

PHARMACEUTICAL SOLUTIONS LIMITED, THE OLD BAKERY, HIGH STREET, TARVIN, CHESTER, CH3 8JA, UNITED KINGDOM

4: Legally registered address of authorisation holder PHARMACEUTICAL SOLUTIONS LIMITED, THE OLD BAKERY, HIGH STREET, TARVIN, CHESTER, CH3 8JA, 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 05/04/2024
9: Annexes attached Annex 1 and/or Annex 2
SCOPE OF AUTHORISATION
Annex 2
Name and address of the site:

PHARMACEUTICAL SOLUTIONS LIMITED, THE OLD BAKERY, HIGH STREET, TARVIN, CHESTER, CH3 8JA, 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
    [ 1.1.3 ] Batch certification
[ 1.2 ] Non-sterile investigational medicinal products
    [ 1.2.2 ] Batch certification
[ 1.3 ] Biological investigational medicinal products
    [ 1.3.2 ] Batch certification
        [ 1.3.2.5 ] Biotechnology products
        [ 1.3.2.6 ] Human or animal extracted products
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
    [ 2.2.3 ] Biological medicinal products
        [ 2.2.3.5 ] Biotechnology products
        [ 2.2.3.6 ] Human or animal extracted products
[ 2.3 ] Other Importation Activities
    [ 2.3.2 ] Importation of Intermediate which undergoes further processing
    [ 2.3.4 ] Other
        Importation of QP-certified IMPs from a country on the approved country for import list