Medicines and Healthcare products Regulatory Agency

MANUFACTURER'S AUTHORISATION
1: Authorisation Number UK MIA 20377
2: Name of authorisation holder ALMAC CLINICAL SERVICES LIMITED
3: Address(es) of manufacturing site(s)

ALMAC CLINICAL SERVICES LIMITED, SEAGOE INDUSTRIAL ESTATE, 9 CHARLESTOWN ROAD, CRAIGAVON, NORTHERN IRELAND, BT63 5PW, UNITED KINGDOM

4: Legally registered address of authorisation holder ALMAC CLINICAL SERVICES LIMITED, SEAGOE INDUSTRIAL ESTATE, 9 CHARLESTOWN ROAD, CRAIGAVON, NORTHERN IRELAND, BT63 5PW, 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 17/04/2024
9: Annexes attached Annex 1 and/or Annex 2
SCOPE OF AUTHORISATION
Annex 1
Name and address of the site:

ALMAC CLINICAL SERVICES LIMITED, SEAGOE INDUSTRIAL ESTATE, 9 CHARLESTOWN ROAD, CRAIGAVON, NORTHERN IRELAND, BT63 5PW, UNITED KINGDOM

Human Medicinal Products
Authorised Operations
Authorised Operations
MANUFACTURING OPERATIONS (according to part 1)
Operations
Part 1 - MANUFACTURING OPERATIONS
[ 1.1 ] Sterile Products
    [ 1.1.3 ] Batch certification
[ 1.2 ] Non-sterile products
    [ 1.2.2 ] Batch certification
[ 1.3 ] Biological medicinal products
    [ 1.3.2 ] Batch certification
        [ 1.3.2.1 ] Blood products
        [ 1.3.2.2 ] Immunological products
        [ 1.3.2.3 ] Cell therapy products
        [ 1.3.2.4 ] Gene therapy products
        [ 1.3.2.5 ] Biotechnology products
        [ 1.3.2.6 ] Human or animal extracted products