Medicines and Healthcare products Regulatory Agency

MANUFACTURER'S AUTHORISATION
1: Authorisation Number UK MIA(IMP) 18351
2: Name of authorisation holder ALCURA UK LIMITED
3: Address(es) of manufacturing site(s)

ALCURA UK LIMITED, ALCURA HOUSE, CASWELL ROAD, BRACKMILLS INDUSTRIAL ESTATE, NORTHAMPTON, NN4 7PU, UNITED KINGDOM

4: Legally registered address of authorisation holder ALCURA UK LIMITED, ALCURA HOUSE, CASWELL ROAD, BRACKMILLS INDUSTRIAL ESTATE, NORTHAMPTON, NN4 7PU, 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 19/08/2024
9: Annexes attached Annex 1 and/or Annex 2
SCOPE OF AUTHORISATION
Annex 2
Name and address of the site:

ALCURA UK LIMITED, ALCURA HOUSE, CASWELL ROAD, BRACKMILLS INDUSTRIAL ESTATE, NORTHAMPTON, NN4 7PU, 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
[ 2.3 ] Other Importation Activities
    [ 2.3.1 ] Site of Physical Importation
    [ 2.3.4 ] Other
        Importation of QP certified IMPs from a country on the 'approved country for import list'/Returns and destruction of IMPs