Medicines and Healthcare products Regulatory Agency
| 1: Authorisation Number | UK MIA(IMP) 35718 |
|---|---|
| 2: Name of authorisation holder | QUOTIENT SCIENCES LIMITED |
| 3: Address(es) of manufacturing site(s) |
QUOTIENT SCIENCES LIMITED, TRENT HOUSE/SHERWOOD HOUSE/LIME HOUSE, MERE WAY, RUDDINGTON FIELDS, RUDDINGTON, NOTTINGHAM, NG11 6JS, UNITED KINGDOM QUOTIENT SCIENCES LIMITED, 5 BOULTON ROAD, READING, RG2 0NH, UNITED KINGDOM |
| 4: Legally registered address of authorisation holder | QUOTIENT SCIENCES LIMITED, TRENT HOUSE, MERE WAY, RUDDINGTON FIELDS BUSINESS PARK, RUDDINGTON, NOTTINGHAM, NG11 6JS, 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 | 09/05/2024 |
| 9: Annexes attached | Annex 1 and/or Annex 2 |
SCOPE OF AUTHORISATION
Annex 2
Name and address of the site:
QUOTIENT SCIENCES LIMITED, TRENT HOUSE/SHERWOOD HOUSE/LIME HOUSE, MERE WAY, RUDDINGTON FIELDS, RUDDINGTON, NOTTINGHAM, NG11 6JS, UNITED KINGDOM
Human Investigational Medicinal Products
| Authorised Operations |
| MANUFACTURING OPERATIONS (according to part 1)IMPORTATION OF MEDICINAL PRODUCTS (according to part 2) |
| Part 1 - MANUFACTURING OPERATIONS |
| [ 1.1 ] Sterile Investigational Medicinal Products |
| [ 1.1.1 ] Aseptically prepared (processing operations for the following dosage forms) |
| [ 1.1.1.6 ] Other aseptically prepared products Clinical labelling and/or randomisation & blinding and batch certification of sterile IMPs manufactured at other authorised manufacturing sites |
| [ 1.1.3 ] Batch certification |
| [ 1.2 ] Non-sterile investigational medicinal products |
| [ 1.2.1 ] Non-Sterile Products (processing operations for the following dosage forms) |
| [ 1.2.1.1 ] Capsules, hard shell |
| [ 1.2.1.5 ] Liquids for external use |
| [ 1.2.1.6 ] Liquids for internal use |
| [ 1.2.1.8 ] Other solid dosage forms |
| [ 1.2.1.9 ] Pressurised preparations |
| [ 1.2.1.11 ] Semi-solids |
| [ 1.2.1.12 ] Suppositories |
| [ 1.2.1.13 ] Tablets |
| [ 1.2.1.15 ] Other non-sterile medicinal products Any products listed in 1.2 may be radiolabelled and contain antibiotics, cytotoxics, biotechnology, human or animal derived products. |
| [ 1.2.2 ] Batch certification |
| [ 1.3 ] Biological investigational medicinal products |
| [ 1.3.1 ] Biological medicinal products |
| [ 1.3.1.5 ] Biotechnology products |
| [ 1.3.1.8 ] Other biological medicinal products Radiolabelling and/or aseptic assembly of pre-formulated biologicals. Any of the products listed in section 1.3 may contain Antibiotics, Cytototoxics, Biotechnology and Human or Animal derived products. |
| [ 1.3.2 ] Batch certification |
| [ 1.3.2.5 ] Biotechnology products |
| [ 1.4 ] Other investigational medicinal products or manufacturing activitiy |
| [ 1.4.2 ] Sterilisation of active substances/excipients/finished products: |
| [ 1.4.2.1 ] Filtration |
| [ 1.5 ] Packaging |
| [ 1.5.1 ] Primary packaging |
| [ 1.5.1.1 ] Capsules, hard shell |
| [ 1.5.1.5 ] Liquids for external use |
| [ 1.5.1.6 ] Liquids for internal use |
| [ 1.5.1.8 ] Other solid dosage forms |
| [ 1.5.1.9 ] Pressurised preparations |
| [ 1.5.1.11 ] Semi-solids |
| [ 1.5.1.12 ] Suppositories |
| [ 1.5.1.13 ] Tablets |
| [ 1.5.2 ] Secondary packaging |
| [ 1.6 ] Quality control testing |
| [ 1.6.2 ] Microbiological: non-sterility |
| [ 1.6.3 ] Chemical/Physical |
| Part 2 - IMPORTATION OF MEDICINAL PRODUCTS |
| [ 2.1 ] Quality control testing of imported medicinal products |
| [ 2.1.2 ] Microbiological: non-sterility |
| [ 2.1.3 ] Chemical/Physical |
| [ 2.2 ] Batch certification of imported medicinal products |
| [ 2.2.1 ] Sterile Products |
| [ 2.2.1.1 ] Aseptically prepared |
| [ 2.2.2 ] Non-sterile products |
| [ 2.2.3 ] Biological medicinal products |
| [ 2.2.3.8 ] Other biological medicinal products Radiolabelling and/or aseptic assembly of pre-formulated biologicals. Any of the products listed in section 1.3 may contain Antibiotics, Cytototoxics, Biotechnology and Human or Animal derived 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 ] Other Importation of QP-certified IMPs from a country on the approved country for import list |
SCOPE OF AUTHORISATION
Annex 2
Name and address of the site:
QUOTIENT SCIENCES LIMITED, 5 BOULTON ROAD, READING, RG2 0NH, UNITED KINGDOM
Human Investigational Medicinal Products
| Authorised Operations |
| MANUFACTURING OPERATIONS (according to part 1)IMPORTATION OF MEDICINAL PRODUCTS (according to part 2) |
| Part 1 - MANUFACTURING OPERATIONS |
| [ 1.2 ] Non-sterile investigational medicinal products |
| [ 1.2.1 ] Non-Sterile Products (processing operations for the following dosage forms) |
| [ 1.2.1.1 ] Capsules, hard shell |
| [ 1.2.1.5 ] Liquids for external use |
| [ 1.2.1.6 ] Liquids for internal use |
| [ 1.2.1.8 ] Other solid dosage forms |
| [ 1.2.1.9 ] Pressurised preparations |
| [ 1.2.1.11 ] Semi-solids |
| [ 1.2.1.12 ] Suppositories |
| [ 1.2.1.13 ] Tablets |
| [ 1.2.1.15 ] Other non-sterile medicinal products Blister/Multidose Resovoir Dry Powder Inhaler,DPI/PMDI |
| [ 1.2.2 ] Batch certification |
| [ 1.3 ] Biological investigational medicinal products |
| [ 1.3.1 ] Biological medicinal products |
| [ 1.3.1.5 ] Biotechnology products |
| [ 1.3.2 ] Batch certification |
| [ 1.3.2.5 ] Biotechnology products |
| [ 1.4 ] Other investigational medicinal products or manufacturing activitiy |
| [ 1.4.1 ] Manufacture of: |
| [ 1.4.1.1 ] Herbal products |
| [ 1.4.1.3 ] Other Traditional Herbal Medicines/Importation of QP-certified IMPs from a country on the approved country for import list |
| [ 1.5 ] Packaging |
| [ 1.5.1 ] Primary packaging |
| [ 1.5.1.1 ] Capsules, hard shell |
| [ 1.5.1.2 ] Capsules, soft shell |
| [ 1.5.1.8 ] Other solid dosage forms |
| [ 1.5.1.9 ] Pressurised preparations |
| [ 1.5.1.11 ] Semi-solids |
| [ 1.5.1.12 ] Suppositories |
| [ 1.5.1.13 ] Tablets |
| [ 1.5.1.14 ] Transdermal patches |
| [ 1.5.2 ] Secondary packaging |
| [ 1.6 ] Quality control testing |
| [ 1.6.3 ] Chemical/Physical |
| [ 1.6.4 ] Biological |
| 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 |
| [ 2.3 ] Other Importation Activities |
| [ 2.3.1 ] Site of Physical Importation |
| [ 2.3.4 ] Other Traditional Herbal Medicines/Importation of QP-certified IMPs from a country on the approved country for import list |