Medicines and Healthcare products Regulatory Agency
| 1: Authorisation Number | UK MIA(IMP) 49464 |
|---|---|
| 2: Name of authorisation holder | ENTEROBIOTIX LIMITED |
| 3: Address(es) of manufacturing site(s) |
ENTEROBIOTIX LIMITED, UNIT 2.3 WESTERN CAMPUS, STARLING WAY, STRATHCLYDE BUSINESS PARK, BELLSHILL, ML4 3PU, UNITED KINGDOM ENTEROBIOTIX LIMITED, ABERDEEN BLOOD TRANSFUSION CENTRE, FORESTERHILL ROAD, ABERDEEN, AB25 2ZW, UNITED KINGDOM |
| 4: Legally registered address of authorisation holder | ENTEROBIOTIX LIMITED, PHOENIX HOUSE, STRATHCLYDE BUSINESS PARK, BELLSHILL, ML4 3NJ, 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 | 21/08/2023 |
| 9: Annexes attached | Annex 1 and/or Annex 2 |
SCOPE OF AUTHORISATION
Annex 2
Name and address of the site:
ENTEROBIOTIX LIMITED, UNIT 2.3 WESTERN CAMPUS, STARLING WAY, STRATHCLYDE BUSINESS PARK, BELLSHILL, ML4 3PU, UNITED KINGDOM
Human Investigational Medicinal Products
| Authorised Operations |
| MANUFACTURING OPERATIONS (according to part 1) |
| 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 |
| [ 1.2.1.15 ] Other non-sterile medicinal products Faecal Microbiota |
| [ 1.2.2 ] Batch certification |
| [ 1.3 ] Biological investigational medicinal products |
| [ 1.3.1 ] Biological medicinal products |
| [ 1.3.1.6 ] Human or animal extracted products |
| [ 1.3.1.8 ] Other biological medicinal products Faecal Microbiota |
| [ 1.3.2 ] Batch certification |
| [ 1.3.2.6 ] Human or animal extracted products |
| [ 1.3.2.8 ] Other biological medicinal products Faecal Microbiota |
| [ 1.5 ] Packaging |
| [ 1.5.1 ] Primary packaging |
| [ 1.5.1.1 ] Capsules, hard shell |
| [ 1.6 ] Quality control testing |
| [ 1.6.2 ] Microbiological: non-sterility |
| [ 1.6.3 ] Chemical/Physical |
| [ 1.6.4 ] Biological |
SCOPE OF AUTHORISATION
Annex 2
Name and address of the site:
ENTEROBIOTIX LIMITED, ABERDEEN BLOOD TRANSFUSION CENTRE, FORESTERHILL ROAD, ABERDEEN, AB25 2ZW, UNITED KINGDOM
Human Investigational Medicinal Products
| Authorised Operations |
| MANUFACTURING OPERATIONS (according to part 1) |
| Part 1 - MANUFACTURING OPERATIONS |
| [ 1.2 ] Non-sterile investigational medicinal products |
| [ 1.2.1 ] Non-Sterile Products (processing operations for the following dosage forms) |
| [ 1.2.1.6 ] Liquids for internal use |
| [ 1.2.1.15 ] Other non-sterile medicinal products FAECAL MICROBIOTA |
| [ 1.2.2 ] Batch certification |
| [ 1.3 ] Biological investigational medicinal products |
| [ 1.3.1 ] Biological medicinal products |
| [ 1.3.1.6 ] Human or animal extracted products |
| [ 1.3.1.8 ] Other biological medicinal products FAECAL MICROBIOTA |
| [ 1.5 ] Packaging |
| [ 1.5.1 ] Primary packaging |
| [ 1.5.1.6 ] Liquids for internal use |
| [ 1.5.1.15 ] Other non-sterile medicinal products FAECAL MICROBIOTA |
| [ 1.5.2 ] Secondary packaging |
| [ 1.6 ] Quality control testing |
| [ 1.6.1 ] Microbiological: sterility |