Medicines and Healthcare products Regulatory Agency

MANUFACTURER'S AUTHORISATION
1: Authorisation Number UK MIA 4296
2: Name of authorisation holder B BRAUN MEDICAL LIMITED
3: Address(es) of manufacturing site(s)

B BRAUN MEDICAL LIMITED, UNIT 8, BROOKDALE ROAD, THORNCLIFFE PARK ESTATE, CHAPELTOWN, SHEFFIELD, S35 2PW, UNITED KINGDOM

4: Legally registered address of authorisation holder B BRAUN MEDICAL LIMITED, UNIT 8, BROOKDALE ROAD, THORNCLIFFE PARK ESTATE, CHAPELTOWN, SHEFFIELD, S35 2PW, 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 05/11/2024
9: Annexes attached Annex 1 and/or Annex 2
SCOPE OF AUTHORISATION
Annex 1
Name and address of the site:

B BRAUN MEDICAL LIMITED, UNIT 8, BROOKDALE ROAD, THORNCLIFFE PARK ESTATE, CHAPELTOWN, SHEFFIELD, S35 2PW, 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
    [ 2.2.1 ] Sterile Products
        [ 2.2.1.2 ] Terminally sterilised