Medicines and Healthcare products Regulatory Agency
1: Authorisation Number | UK MIA(IMP) 1384 |
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2: Name of authorisation holder | UNIVERSITY OF EDINBURGH |
3: Address(es) of manufacturing site(s) |
HEALTHCARE TECHNOLOGY ACCELERATOR FACILITY (HTAF) STERILE FILL UNIT (SFU), STERILE FILL UNIT, QUEENS MEDICAL RESEARCH INSTITUTE, 47 LITTLE FRANCE CRESCENT, EDINBURGH, EH16 4TJ, UNITED KINGDOM UNIVERSITY OF EDINBURGH - PET RADIOCHEMISTRY, QUEENS MEDICAL RESEARCH INSTITUTE, 47 LITTLE FRANCE CRESCENT, EDINBURGH, EH16 4TJ, UNITED KINGDOM UNIVERSITY OF EDINBURGH - INVESTIGATIONAL SUPPLIES GROUP, 1 GEORGE SQUARE, EDINBURGH, EH8 9JZ, UNITED KINGDOM |
4: Legally registered address of authorisation holder | UNIVERSITY OF EDINBURGH, OLD COLLEGE, SOUTH BRIDGE, EDINBURGH, EH8 9YL, 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 | 04/04/2025 |
9: Annexes attached | Annex 1 and/or Annex 2 |
HEALTHCARE TECHNOLOGY ACCELERATOR FACILITY (HTAF) STERILE FILL UNIT (SFU), STERILE FILL UNIT, QUEENS MEDICAL RESEARCH INSTITUTE, 47 LITTLE FRANCE CRESCENT, EDINBURGH, EH16 4TJ, UNITED KINGDOM
Authorised Operations |
MANUFACTURING OPERATIONS (according to part 1) |
Part 1 - MANUFACTURING OPERATIONS |
[ 1.1 ] Sterile Investigational Medicinal Products |
[ 1.1.1 ] Aseptically prepared (processing operations for the following dosage forms) |
[ 1.1.1.4 ] Small volume liquids |
[ 1.4 ] Other investigational medicinal products or manufacturing activitiy |
[ 1.4.2 ] Sterilisation of active substances/excipients/finished products: |
[ 1.4.2.1 ] Filtration |
[ 1.6 ] Quality control testing |
[ 1.6.3 ] Chemical/Physical |
UNIVERSITY OF EDINBURGH - PET RADIOCHEMISTRY, QUEENS MEDICAL RESEARCH INSTITUTE, 47 LITTLE FRANCE CRESCENT, EDINBURGH, EH16 4TJ, UNITED KINGDOM
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) |
[ 1.1.1.4 ] Small volume liquids Special Requirements Radiopharmaceuticals |
[ 1.1.2 ] Terminally Sterilised (processing operations for the following dosage forms) |
[ 1.1.2.3 ] Small volume liquids |
[ 1.1.2.5 ] Other terminally sterilised prepared products Radiopharmaceuticals |
[ 1.4 ] Other investigational medicinal products or manufacturing activitiy |
[ 1.4.2 ] Sterilisation of active substances/excipients/finished products: |
[ 1.4.2.1 ] Filtration |
[ 1.4.2.3 ] Moist heat |
[ 1.6 ] Quality control testing |
[ 1.6.2 ] Microbiological: non-sterility |
[ 1.6.3 ] Chemical/Physical |
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 |
UNIVERSITY OF EDINBURGH - INVESTIGATIONAL SUPPLIES GROUP, 1 GEORGE SQUARE, EDINBURGH, EH8 9JZ, UNITED KINGDOM
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 |
[ 1.2.1.11 ] Semi-solids |
[ 1.5 ] Packaging |
[ 1.5.1 ] Primary packaging |
[ 1.5.1.2 ] Capsules, soft shell |
[ 1.5.1.12 ] Suppositories |
[ 1.5.1.13 ] Tablets |
[ 1.5.1.15 ] Other non-sterile medicinal products Powders |
[ 1.5.2 ] Secondary packaging |
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 |
[ 2.2.3 ] Biological medicinal products |
[ 2.2.3.1 ] Blood products |
[ 2.2.3.2 ] Immunological products |
[ 2.2.3.4 ] Gene therapy products |
[ 2.2.3.5 ] Biotechnology products |
[ 2.2.3.6 ] Human or animal extracted products |