Medicines and Healthcare products Regulatory Agency
1: Authorisation Number | UK MIA 44646 |
---|---|
2: Name of authorisation holder | SMIRO QUALITAS LIMITED |
3: Address(es) of manufacturing site(s) |
SMIRO QUALITAS LIMITED, 4 FLATFORD ROAD, HAVERHILL, CB9 7WW, UNITED KINGDOM |
4: Legally registered address of authorisation holder | SMIRO QUALITAS LIMITED, 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 | 26/07/2024 |
9: Annexes attached | Annex 1 and/or Annex 2 |
SCOPE OF AUTHORISATION
Annex 1
Name and address of the site:
SMIRO QUALITAS LIMITED, 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 |
[ 2.2.2 ] Non-sterile products |
[ 2.2.3 ] Biological medicinal products |
[ 2.2.3.2 ] Immunological products |
[ 2.3 ] Other Importation Activities |
[ 2.3.4 ] Products authorised under regulation 174 (supply in response to spread of pathogenic agents etc) GMP Certification and Batch release of imported biological imported Product- Monoclonal antibodies, Vaccines, oral vaccines, recombinant proteins, MVAs and adjuvants |