Medicines and Healthcare products Regulatory Agency

MANUFACTURER'S AUTHORISATION
1: Authorisation Number UK MIA(IMP) 59204
2: Name of authorisation holder HITECH HEALTH (UK) LIMITED
3: Address(es) of manufacturing site(s)

HITECH HEALTH UK LIMITED, NO.2 GLASSHOUSE- 2S9, ALDERLEY PARK, CONGLETON ROAD, NETHER ALDERLEY, MACCLESFIELD, SK10 4ZE, UNITED KINGDOM

4: Legally registered address of authorisation holder HITECH HEALTH (UK) LIMITED, NO.2 GLASSHOUSE- 2S9, ALDERLEY PARK, CONGLETON ROAD, NETHER ALDERLEY, MACCLESFIELD, SK10 4ZE, 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 19/03/2025
9: Annexes attached Annex 1 and/or Annex 2
SCOPE OF AUTHORISATION
Annex 2
Name and address of the site:

HITECH HEALTH UK LIMITED, NO.2 GLASSHOUSE- 2S9, ALDERLEY PARK, CONGLETON ROAD, NETHER ALDERLEY, MACCLESFIELD, SK10 4ZE, 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
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
        [ 2.2.3.3 ] Cell therapy products
        [ 2.2.3.4 ] Gene therapy products
        [ 2.2.3.5 ] Biotechnology products
[ 2.3 ] Other Importation Activities
    [ 2.3.4 ] Other
        Importation of QP-certified IMPs from a country on the approved country for import list