Medicines and Healthcare products Regulatory Agency
1: Authorisation Number | UK MIA 22443 |
---|---|
2: Name of authorisation holder | ALLIANCE MEDICAL RADIOPHARMACY LIMITED |
3: Address(es) of manufacturing site(s) |
ALLIANCE MEDICAL RADIOPHARMACY LIMITED, UNIT 19, QUADRUM PARK, OLD PORTSMOUTH ROAD, PEASMARSH, GUILDFORD, GU3 1LU, UNITED KINGDOM ALLIANCE MEDICAL RADIOPHARMACY LIMITED , ROYAL PRESTON HOSPITAL, SHAROE GREEN LANE, FULWOOD, PRESTON, PR2 9HT, UNITED KINGDOM ALLIANCE MEDICAL RADIOPHARMACY LIMITED , ROYAL MARSDEN HOSPITAL, DOWNS ROAD, SUTTON, SM2 5PT, UNITED KINGDOM ALLIANCE MEDICAL RADIOPHARMACY LIMITED , KEELE UNIVERSITY SCIENCE PARK, KEELE, NEWCASTLE, ST5 5BX, UNITED KINGDOM ALLIANCE MEDICAL RADIOPHARMACY LIMITED, NOBEL WAY, DINNINGTON, SHEFFIELD, S25 3QB, UNITED KINGDOM |
4: Legally registered address of authorisation holder | ALLIANCE MEDICAL RADIOPHARMACY LIMITED, FIRST FLOOR, THE WOODS, OPUS 40 BUSINESS PARK, HAYWOOD ROAD, WARWICK, CV34 5AH, 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 | 11/03/2024 |
9: Annexes attached | Annex 1 and/or Annex 2 |
ALLIANCE MEDICAL RADIOPHARMACY LIMITED, UNIT 19, QUADRUM PARK, OLD PORTSMOUTH ROAD, PEASMARSH, GUILDFORD, GU3 1LU, 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 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 Radiopharmaceuticals (Small volume liquids) |
[ 1.1.3 ] Batch certification |
[ 1.4 ] Other products or manufacturing activity |
[ 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 |
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 |
[ 2.3 ] Other Importation Activities |
[ 2.3.4 ] Products authorised under regulation 174 (supply in response to spread of pathogenic agents etc) Radiopharmaceuticals/Radionuclide generators/production of positron emmission tomography isoptopes |
ALLIANCE MEDICAL RADIOPHARMACY LIMITED , ROYAL PRESTON HOSPITAL, SHAROE GREEN LANE, FULWOOD, PRESTON, PR2 9HT, UNITED KINGDOM
Authorised Operations |
MANUFACTURING OPERATIONS (according to part 1) |
Part 1 - MANUFACTURING OPERATIONS |
[ 1.1 ] Sterile Products |
[ 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 (Small volume liquids) |
[ 1.1.3 ] Batch certification |
[ 1.4 ] Other products or manufacturing activity |
[ 1.4.2 ] Sterilisation of active substances/excipients/finished products: |
[ 1.4.2.3 ] Moist heat |
[ 1.4.3 ] Other Radiopharmaceuticals (Moist Heat) |
[ 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 |
ALLIANCE MEDICAL RADIOPHARMACY LIMITED , ROYAL MARSDEN HOSPITAL, DOWNS ROAD, SUTTON, SM2 5PT, UNITED KINGDOM
Authorised Operations |
MANUFACTURING OPERATIONS (according to part 1) |
Part 1 - MANUFACTURING OPERATIONS |
[ 1.1 ] Sterile Products |
[ 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 (Small volume liquids) |
[ 1.1.3 ] Batch certification |
[ 1.4 ] Other products or manufacturing activity |
[ 1.4.2 ] Sterilisation of active substances/excipients/finished products: |
[ 1.4.2.3 ] Moist heat |
[ 1.4.3 ] Other Radiopharmaceuticals (moist heat) |
[ 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 |
ALLIANCE MEDICAL RADIOPHARMACY LIMITED , KEELE UNIVERSITY SCIENCE PARK, KEELE, NEWCASTLE, ST5 5BX, UNITED KINGDOM
Authorised Operations |
MANUFACTURING OPERATIONS (according to part 1) |
Part 1 - MANUFACTURING OPERATIONS |
[ 1.1 ] Sterile Products |
[ 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(small volume liquids) |
[ 1.1.3 ] Batch certification |
[ 1.4 ] Other products or manufacturing activity |
[ 1.4.2 ] Sterilisation of active substances/excipients/finished products: |
[ 1.4.2.3 ] Moist heat |
[ 1.4.3 ] Other Radiopharmaceuticals (moist heat) |
[ 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 |
ALLIANCE MEDICAL RADIOPHARMACY LIMITED, NOBEL WAY, DINNINGTON, SHEFFIELD, S25 3QB, 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 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 Radiopharmaceuticals (small volume liquids) |
[ 1.1.3 ] Batch certification |
[ 1.4 ] Other products or manufacturing activity |
[ 1.4.1 ] Manufacture of: |
[ 1.4.1.3 ] Other Radiopharmaceuticals |
[ 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 |
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 |