Medicines and Healthcare products Regulatory Agency

MANUFACTURER'S AUTHORISATION
1: Authorisation Number UK MIA 41102
2: Name of authorisation holder GH PHARMA (UK) LIMITED
3: Address(es) of manufacturing site(s)

GH PHARMA (UK) LIMITED, 12 THE BROADWAY, ST. IVES, PE27 5BN, UNITED KINGDOM

4: Legally registered address of authorisation holder GH PHARMA (UK) LIMITED, CHARLTON HOUSE, DOUR STREET, DOVER, CT16 1BL, 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 13/12/2023
9: Annexes attached Annex 1 and/or Annex 2
SCOPE OF AUTHORISATION
Annex 1
Name and address of the site:

GH PHARMA (UK) LIMITED, 12 THE BROADWAY, ST. IVES, PE27 5BN, UNITED KINGDOM

Human 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 Products
    [ 1.1.3 ] Batch certification
Part 2 - IMPORTATION OF MEDICINAL PRODUCTS
[ 2.2 ] Batch certification of imported medicinal products
    [ 2.2.1 ] Sterile Products
        [ 2.2.1.2 ] Terminally sterilised