Medicines and Healthcare products Regulatory Agency

MANUFACTURER'S AUTHORISATION
1: Authorisation Number UK MIA 30619
2: Name of authorisation holder CLINUVEL (UK) LIMITED
3: Address(es) of manufacturing site(s)

CLINUVEL (UK) LIMITED, WESLEY HOUSE, BULL HILL, LEATHERHEAD, KT22 7AH, UNITED KINGDOM

4: Legally registered address of authorisation holder CLINUVEL (UK) LIMITED, DEVONSHIRE HOUSE, 60 GOSWELL ROAD, LONDON, EC1M 7AD, 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 29/06/2018
9: Annexes attached Annex 1 and/or Annex 2
SCOPE OF AUTHORISATION
Annex 1
Name and address of the site:

CLINUVEL (UK) LIMITED, WESLEY HOUSE, BULL HILL, LEATHERHEAD, KT22 7AH, UNITED KINGDOM

Human Medicinal Products
Authorised Operations
Authorised Operations
IMPORTATION OF MEDICINAL PRODUCTS (according to part 2)
Operations
Part 2 - IMPORTATION OF MEDICINAL PRODUCTS
[ 2.3 ] Other Importation Activities
    [ 2.3.2 ] Importation of Intermediate which undergoes further processing