Medicines and Healthcare products Regulatory Agency

MANUFACTURER'S AUTHORISATION
1: Authorisation Number UK MIA 41013
2: Name of authorisation holder SEACROSS PHARMACEUTICALS LIMITED
3: Address(es) of manufacturing site(s)

SEACROSS PHARMACEUTICALS LIMITED, STANMORE BUSINESS & INNOVATION CENTRE, STANMORE PLACE, HOWARD ROAD, STANMORE, HA7 1BT, UNITED KINGDOM

4: Legally registered address of authorisation holder SEACROSS PHARMACEUTICALS LIMITED, STANMORE BUSINESS & INNOVATION CENTRE, STANMORE PLACE, HOWARD ROAD, STANMORE, HA7 1BT, 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 22/04/2024
9: Annexes attached Annex 1 and/or Annex 2
SCOPE OF AUTHORISATION
Annex 1
Name and address of the site:

SEACROSS PHARMACEUTICALS LIMITED, STANMORE BUSINESS & INNOVATION CENTRE, STANMORE PLACE, HOWARD ROAD, STANMORE, HA7 1BT, 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
        [ 2.2.1.1 ] Aseptically prepared
        [ 2.2.1.2 ] Terminally sterilised
    [ 2.2.2 ] Non-sterile products