Medicines and Healthcare products Regulatory Agency

MANUFACTURER'S AUTHORISATION
1: Authorisation Number UK MIA(IMP) 10555
2: Name of authorisation holder EISAI LIMITED
3: Address(es) of manufacturing site(s)

EISAI LIMITED, EUROPEAN KNOWLEDGE CENTRE, MOSQUITO WAY, HATFIELD, AL10 9SN, UNITED KINGDOM

4: Legally registered address of authorisation holder EISAI LIMITED, EUROPEAN KNOWLEDGE CENTRE, MOSQUITO WAY, HATFIELD, AL10 9SN, 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 14/10/2021
9: Annexes attached Annex 1 and/or Annex 2
SCOPE OF AUTHORISATION
Annex 2
Name and address of the site:

EISAI LIMITED, EUROPEAN KNOWLEDGE CENTRE, MOSQUITO WAY, HATFIELD, AL10 9SN, 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
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
[ 2.3 ] Other Importation Activities
    [ 2.3.2 ] Importation of Intermediate which undergoes further processing
    [ 2.3.4 ] Other
        Radiopharmaceuticals/Radionuclide generators and Biological active starting materials