Medicines and Healthcare products Regulatory Agency

MANUFACTURER'S AUTHORISATION
1: Authorisation Number UK MIA 34771
2: Name of authorisation holder MACLEODS PHARMA UK LIMITED
3: Address(es) of manufacturing site(s)

MACLEODS PHARMA UK LIMITED, WYNYARD PARK HOUSE, WYNYARD AVENUE, WYNYARD, BILLINGHAM, TS22 5TB, UNITED KINGDOM

4: Legally registered address of authorisation holder MACLEODS PHARMA UK LIMITED, WYNYARD PARK HOUSE, WYNYARD AVENUE, WYNYARD, BILLINGHAM, TS22 5TB, 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 09/05/2024
9: Annexes attached Annex 1 and/or Annex 2
SCOPE OF AUTHORISATION
Annex 1
Name and address of the site:

MACLEODS PHARMA UK LIMITED, WYNYARD PARK HOUSE, WYNYARD AVENUE, WYNYARD, BILLINGHAM, TS22 5TB, UNITED KINGDOM

Human Medicinal Products
Authorised Operations
Authorised Operations
IMPORTATION OF MEDICINAL PRODUCTS (according to part 2)
Operations
Part 2 - IMPORTATION OF MEDICINAL PRODUCTS
[ 2.2 ] Batch certification of imported medicinal products
    [ 2.2.2 ] Non-sterile products