Medicines and Healthcare products Regulatory Agency

MANUFACTURER'S AUTHORISATION
1: Authorisation Number UK MIA(IMP) 47685
2: Name of authorisation holder CLINICAL SERVICES INTERNATIONAL LIMITED
3: Address(es) of manufacturing site(s)

CLINICAL SERVICES INTERNATIONAL, SUITE 212, 50 SLOANE AVENUE, LONDON, SW3 3DD, UNITED KINGDOM

4: Legally registered address of authorisation holder CLINICAL SERVICES INTERNATIONAL LIMITED, SUITE 212, 50 SLOANE AVENUE, LONDON, SW3 3DD, 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 11/06/2024
9: Annexes attached Annex 1 and/or Annex 2
SCOPE OF AUTHORISATION
Annex 2
Name and address of the site:

CLINICAL SERVICES INTERNATIONAL, SUITE 212, 50 SLOANE AVENUE, LONDON, SW3 3DD, UNITED KINGDOM

Human Investigational 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
    [ 2.2.3 ] Biological medicinal products
        [ 2.2.3.2 ] Immunological products
        [ 2.2.3.5 ] Biotechnology products
        [ 2.2.3.6 ] Human or animal extracted products
        [ 2.2.3.8 ] Other biological medicinal products
            Microbial derived
[ 2.3 ] Other Importation Activities
    [ 2.3.2 ] Importation of Intermediate which undergoes further processing