Medicines and Healthcare products Regulatory Agency
| 1: Authorisation Number | UK MIA 60304 |
|---|---|
| 2: Name of authorisation holder | MODERNA BIOTECH MANUFACTURING UK LTD |
| 3: Address(es) of manufacturing site(s) |
MODERNA TECHNOLOGY CENTRE - HARWELL (MTC-H), 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 | 19/06/2025 |
| 9: Annexes attached | Annex 1 and/or Annex 2 |
SCOPE OF AUTHORISATION
Annex 1
Name and address of the site:
MODERNA TECHNOLOGY CENTRE - HARWELL (MTC-H), PERIMETER ROAD, HARWELL OXFORD, DIDCOT, OX11 0GN, UNITED KINGDOM
Human Medicinal Products
| Authorised Operations |
| MANUFACTURING OPERATIONS (according to part 1) |
| Part 1 - MANUFACTURING OPERATIONS |
| [ 1.1 ] Sterile Products |
| [ 1.1.3 ] Batch certification |
| [ 1.3 ] Biological medicinal products |
| [ 1.3.1 ] Biological medicinal products |
| [ 1.3.1.2 ] Immunological products Special Requirements Manf. of low bioburden drug substance (mRNA) and low bioburden Intermediates (mRNA Lipid Nanoparticle (LNP)) products |
| [ 1.3.1.5 ] Biotechnology products Special Requirements Manf. of low bioburden drug substance (mRNA) and low bioburden Intermediates (mRNA Lipid Nanoparticle (LNP)) products |
| [ 1.3.2 ] Batch certification |
| [ 1.3.2.2 ] Immunological products Special Requirements Manf. of low bioburden drug substance (mRNA) and low bioburden Intermediates (mRNA Lipid Nanoparticle (LNP)) products |
| [ 1.3.2.5 ] Biotechnology products Special Requirements Manf. of low bioburden drug substance (mRNA) and low bioburden Intermediates (mRNA Lipid Nanoparticle (LNP)) products |
| [ 1.6 ] Quality control testing |
| [ 1.6.3 ] Chemical/Physical |
| [ 1.6.4 ] Biological |