Medicines and Healthcare products Regulatory Agency
1: Authorisation Number | UK MIA(IMP) 11149 |
---|---|
2: Name of authorisation holder | ROYAL FREE LONDON NHS FOUNDATION TRUST |
3: Address(es) of manufacturing site(s) |
ROYAL FREE LONDON NHS FOUNDATION TRUST, PHARMACY DEPARTMENT, THE ROYAL FREE HOSPITAL, POND STREET, LONDON, NW3 2QG, UNITED KINGDOM ROYAL FREE LONDON NHS FOUNDATION TRUST, CENTRE FOR CELL, GENE & TISSUE THERAPEUTICS, POND STREET, LONDON, NW3 2QG, UNITED KINGDOM ROYAL FREE LONDON NHS FOUNDATION TRUST, RADIOPHARMACY NUCLEAR MEDICINE, THE ROYAL FREE HOSPITAL, POND STREET, LONDON, NW3 2QG, UNITED KINGDOM |
4: Legally registered address of authorisation holder | ROYAL FREE LONDON NHS FOUNDATION TRUST, PHARMACY DEPARTMENT, THE ROYAL FREE HOSPITAL, POND STREET, LONDON, NW3 2QG, 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 | 17/04/2024 |
9: Annexes attached | Annex 1 and/or Annex 2 |
ROYAL FREE LONDON NHS FOUNDATION TRUST, PHARMACY DEPARTMENT, THE ROYAL FREE HOSPITAL, POND STREET, LONDON, NW3 2QG, 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) |
[ 1.1.1.1 ] Large volume liquids |
[ 1.1.1.3 ] Semi-solids |
[ 1.1.1.4 ] Small volume liquids |
[ 1.1.2 ] Terminally Sterilised (processing operations for the following dosage forms) |
[ 1.1.2.1 ] Large volume liquids |
[ 1.1.2.2 ] Semi-solids |
[ 1.1.2.3 ] Small volume liquids |
[ 1.1.2.5 ] Other terminally sterilised prepared products Ampoules, Creams, Powders, Medicated Dressings, (sent away for sterilisation by irradiation), and Bone Wax. |
[ 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 |
[ 1.2.1.11 ] Semi-solids |
[ 1.2.1.13 ] Tablets |
[ 1.3 ] Biological investigational medicinal products |
[ 1.3.1 ] Biological medicinal products |
[ 1.3.1.1 ] Blood products |
[ 1.3.1.2 ] Immunological products |
[ 1.3.1.6 ] Human or animal extracted products |
[ 1.3.1.8 ] Other biological medicinal products Proteins, Peptides |
[ 1.3.2 ] Batch certification |
[ 1.3.2.1 ] Blood products |
[ 1.3.2.2 ] Immunological products |
[ 1.3.2.6 ] Human or animal extracted 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 |
[ 1.4.2.2 ] Dry heat |
[ 1.4.2.3 ] Moist heat |
[ 1.5 ] Packaging |
[ 1.5.1 ] Primary packaging |
[ 1.5.1.1 ] Capsules, hard shell |
[ 1.5.1.2 ] Capsules, soft shell |
[ 1.5.1.5 ] Liquids for external use |
[ 1.5.1.6 ] Liquids for internal use |
[ 1.5.1.8 ] Other solid dosage forms |
[ 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 |
[ 2.1.1 ] Microbiological: sterility |
[ 2.1.2 ] Microbiological: non-sterility |
[ 2.1.3 ] Chemical/Physical |
[ 2.1.4 ] Biological |
[ 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 |
[ 2.3.2 ] Importation of Intermediate which undergoes further processing |
ROYAL FREE LONDON NHS FOUNDATION TRUST, CENTRE FOR CELL, GENE & TISSUE THERAPEUTICS, POND STREET, LONDON, NW3 2QG, 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) |
[ 1.1.1.5 ] Solids and implants |
[ 1.1.1.6 ] Other aseptically prepared products ATMPs |
[ 1.1.3 ] Batch certification |
[ 1.3 ] Biological investigational medicinal products |
[ 1.3.1 ] Biological medicinal products |
[ 1.3.1.3 ] Cell therapy products |
[ 1.3.1.4 ] Gene therapy products |
[ 1.3.1.7 ] Tissue Engineered Products |
[ 1.3.1.8 ] Other biological medicinal products INTERMEDIATE MATERIALS: TISSUE CULTURE SUPERNATANTS |
[ 1.3.2 ] Batch certification |
[ 1.3.2.3 ] Cell therapy products |
[ 1.3.2.4 ] Gene therapy products |
[ 1.3.2.7 ] Tissue Engineered Products |
[ 1.5 ] Packaging |
[ 1.5.2 ] Secondary packaging |
[ 1.6 ] Quality control testing |
[ 1.6.1 ] Microbiological: sterility |
[ 1.6.4 ] Biological |
Part 2 - IMPORTATION OF MEDICINAL PRODUCTS |
[ 2.1 ] Quality control testing of imported medicinal products |
[ 2.1.1 ] Microbiological: sterility |
[ 2.1.4 ] Biological |
[ 2.2 ] Batch certification of imported medicinal products |
[ 2.2.3 ] Biological medicinal products |
[ 2.2.3.3 ] Cell therapy products |
[ 2.2.3.4 ] Gene therapy products |
[ 2.3 ] Other Importation Activities |
[ 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 |
ROYAL FREE LONDON NHS FOUNDATION TRUST, RADIOPHARMACY NUCLEAR MEDICINE, THE ROYAL FREE HOSPITAL, POND STREET, LONDON, NW3 2QG, 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 |
[ 1.1.1.6 ] Other aseptically prepared products Radio Pharmaceuticals |
[ 1.3 ] Biological investigational medicinal products |
[ 1.3.1 ] Biological medicinal products |
[ 1.3.1.2 ] Immunological products |
[ 1.3.1.3 ] Cell therapy products |
[ 1.3.1.4 ] Gene therapy products |
[ 1.3.1.6 ] Human or animal extracted products |
[ 1.3.1.8 ] Other biological medicinal products Proteins, Peptides |
[ 1.3.2 ] Batch certification |
[ 1.3.2.2 ] Immunological products |
[ 1.3.2.3 ] Cell therapy products |
[ 1.3.2.4 ] Gene therapy products |
[ 1.3.2.6 ] Human or animal extracted products |
[ 1.3.2.8 ] Other biological medicinal products Proteins, Peptides |
[ 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 |
[ 1.5.1.6 ] Liquids for internal use |
[ 1.5.2 ] Secondary packaging |
[ 1.6 ] Quality control testing |
[ 1.6.2 ] Microbiological: non-sterility |
[ 1.6.3 ] Chemical/Physical |
[ 1.6.4 ] Biological |