Medicines and Healthcare products Regulatory Agency
| 1: Authorisation Number | UK MIA 62112 |
|---|---|
| 2: Name of authorisation holder | SMIRO QUALITAS MANUFACTURING LTD |
| 3: Address(es) of manufacturing site(s) |
SMIRO QUALITAS MANUFACTURING LTD, 4 FLATFORD ROAD, HAVERHILL, CB9 7WW, UNITED KINGDOM SMIRO QUALITAS MANUFACTURING LTD, UNIT 14, 19, 26 AND 27 HOLLANDS ROAD BUSINESS CENTRE, 21-27 HOLLANDS ROAD, HAVERHILL, CB9 8PU, UNITED KINGDOM |
| 4: Legally registered address of authorisation holder | SMIRO QUALITAS MANUFACTURING LTD, 4 FLATFORD ROAD, HAVERHILL, CB9 7WW, 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 | 30/06/2026 |
| 9: Annexes attached | Annex 1 and/or Annex 2 |
SCOPE OF AUTHORISATION
Annex 1
Name and address of the site:
SMIRO QUALITAS MANUFACTURING LTD, 4 FLATFORD ROAD, HAVERHILL, CB9 7WW, UNITED KINGDOM
Human Medicinal Products
| Authorised Operations |
| IMPORTATION OF MEDICINAL PRODUCTS (according to part 2) |
| 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 |
| [ 2.2.3 ] Biological medicinal products |
| [ 2.2.3.1 ] Blood products |
| [ 2.2.3.2 ] Immunological products |
| [ 2.2.3.3 ] Cell therapy products |
| [ 2.2.3.4 ] Gene therapy products |
| [ 2.2.3.5 ] Biotechnology products |
| [ 2.2.3.6 ] Human or animal extracted products |
| [ 2.3 ] Other Importation Activities |
| [ 2.3.4 ] Products authorised under regulation 174 (supply in response to spread of pathogenic agents etc) GMP Importation and batch release of recombinant proteins,vaccines and adjuvants |
SCOPE OF AUTHORISATION
Annex 1
Name and address of the site:
SMIRO QUALITAS MANUFACTURING LTD, UNIT 14, 19, 26 AND 27 HOLLANDS ROAD BUSINESS CENTRE, 21-27 HOLLANDS ROAD, HAVERHILL, CB9 8PU, UNITED KINGDOM
Human Medicinal Products
| Authorised Operations |
| MANUFACTURING OPERATIONS (according to part 1)IMPORTATION OF MEDICINAL PRODUCTS (according to part 2) |
| Part 1 - MANUFACTURING OPERATIONS |
| [ 1.5 ] Packaging |
| [ 1.5.2 ] Secondary packaging |
| 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 |
| [ 2.2.3 ] Biological medicinal products |
| [ 2.2.3.1 ] Blood products |
| [ 2.2.3.2 ] Immunological products |
| [ 2.2.3.3 ] Cell therapy products |
| [ 2.2.3.4 ] Gene therapy products |
| [ 2.2.3.5 ] Biotechnology products |
| [ 2.2.3.6 ] Human or animal extracted products |
| [ 2.3 ] Other Importation Activities |
| [ 2.3.1 ] Site of Physical Importation |
| [ 2.3.2 ] Importation of Intermediate which undergoes further processing |
| [ 2.3.4 ] Products authorised under regulation 174 (supply in response to spread of pathogenic agents etc) GMP Importation and batch release of recombinant proteins,vaccines and adjuvants. |