Medicines and Healthcare products Regulatory Agency
| 1: Authorisation Number | UK MIA(IMP) 60304 |
|---|---|
| 2: Name of authorisation holder | MODERNA BIOTECH MANUFACTURING UK LTD |
| 3: Address(es) of manufacturing site(s) |
MODERNA BIOTECH MANUFACTURING UK LTD, PERIMETER ROAD, HARWELL OXFORD, DIDCOT, OX11 0GN, UNITED KINGDOM |
| 4: Legally registered address of authorisation holder | MODERNA BIOTECH MANUFACTURING UK LTD, 54 PORTLAND PLACE, LONDON, W1B 1DY, 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 | 22/10/2026 |
| 9: Annexes attached | Annex 1 and/or Annex 2 |
SCOPE OF AUTHORISATION
Annex 2
Name and address of the site:
MODERNA BIOTECH MANUFACTURING UK LTD, PERIMETER ROAD, HARWELL OXFORD, DIDCOT, OX11 0GN, UNITED KINGDOM
Human Investigational 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 |
| [ 2.2.3 ] Biological medicinal products |
| [ 2.2.3.5 ] Biotechnology products |
| [ 2.2.3.8 ] Other biological medicinal products Importation of investigational mRNA-based individualised neoantigen therapy |
| [ 2.3 ] Other Importation Activities |
| [ 2.3.1 ] Site of Physical Importation |