Medicines and Healthcare products Regulatory Agency
| 1: Authorisation Number | UK MIA 49794 |
|---|---|
| 2: Name of authorisation holder | FLEXIPHARM AUSTRADING LIMITED |
| 3: Address(es) of manufacturing site(s) |
FLEXIPHARM AUSTRADING LIMITED, ATI HOUSE, 6 BOSTON DRIVE, BOURNE END, SL8 5YS, UNITED KINGDOM |
| 4: Legally registered address of authorisation holder | FLEXIPHARM AUSTRADING LIMITED, ATI HOUSE, 6 BOSTON DRIVE, BOURNE END, SL8 5YS, 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 | 12/12/2022 |
| 9: Annexes attached | Annex 1 and/or Annex 2 |
SCOPE OF AUTHORISATION
Annex 1
Name and address of the site:
FLEXIPHARM AUSTRADING LIMITED, ATI HOUSE, 6 BOSTON DRIVE, BOURNE END, SL8 5YS, 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 |
| [ 2.2.1.2 ] Terminally sterilised |
| [ 2.2.2 ] Non-sterile products |
| [ 2.3 ] Other Importation Activities |
| [ 2.3.4 ] Products authorised under regulation 174 (supply in response to spread of pathogenic agents etc) Authorised importation activities without manufacturing activity. Site of operations, not site of physical importation. Storage of retention samples |