Medicines and Healthcare products Regulatory Agency
| 1: Authorisation Number | UK MIA 10414 |
|---|---|
| 2: Name of authorisation holder | DOLBY MEDICAL HOME RESPIRATORY CARE LIMITED |
| 3: Address(es) of manufacturing site(s) |
DOLBY MEDICAL HOME RESPIRATORY CARE LIMITED, NORTH SUITE, LOMOND COURT, THE CASTLE BUSINESS PARK, STIRLING, FK9 4TU, UNITED KINGDOM DOLBY MEDICAL HOME RESPIRATORY CARE LIMITED, UNIT 2, BROADLEYS ROAD, SPRINGKERSE INDUSTRIAL ESTATE, STIRLING, FK7 7ST, UNITED KINGDOM DOLBY MEDICAL HOME RESPIRATORY CARE LIMITED, UNIT 18, ARKWRIGHT ROAD INDUSTRIAL ESTATE, ARKWRIGHT ROAD, BEDFORD, MK42 0LQ, UNITED KINGDOM |
| 4: Legally registered address of authorisation holder | DOLBY MEDICAL HOME RESPIRATORY CARE LIMITED, NORTH SUITE, LOMOND COURT, THE CASTLE BUSINESS PARK, STIRLING, FK9 4TU, 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 | 23/04/2024 |
| 9: Annexes attached | Annex 1 and/or Annex 2 |
DOLBY MEDICAL HOME RESPIRATORY CARE LIMITED, NORTH SUITE, LOMOND COURT, THE CASTLE BUSINESS PARK, STIRLING, FK9 4TU, UNITED KINGDOM
| Authorised Operations |
| MANUFACTURING OPERATIONS (according to part 1) |
| Part 1 - MANUFACTURING OPERATIONS |
| [ 1.2 ] Non-sterile products |
| [ 1.2.1 ] Non-Sterile Products (processing operations for the following dosage forms) |
| [ 1.2.1.7 ] Medicinal gases |
| [ 1.2.2 ] Batch certification |
| [ 1.5 ] Packaging |
| [ 1.5.1 ] Primary packaging |
| [ 1.5.1.7 ] Medicinal gases |
| [ 1.6 ] Quality control testing |
| [ 1.6.3 ] Chemical/Physical |
DOLBY MEDICAL HOME RESPIRATORY CARE LIMITED, UNIT 2, BROADLEYS ROAD, SPRINGKERSE INDUSTRIAL ESTATE, STIRLING, FK7 7ST, UNITED KINGDOM
| Authorised Operations |
| MANUFACTURING OPERATIONS (according to part 1) |
| Part 1 - MANUFACTURING OPERATIONS |
| [ 1.2 ] Non-sterile products |
| [ 1.2.1 ] Non-Sterile Products (processing operations for the following dosage forms) |
| [ 1.2.1.7 ] Medicinal gases |
| [ 1.2.2 ] Batch certification |
| [ 1.5 ] Packaging |
| [ 1.5.1 ] Primary packaging |
| [ 1.5.1.7 ] Medicinal gases |
| [ 1.6 ] Quality control testing |
| [ 1.6.3 ] Chemical/Physical |
DOLBY MEDICAL HOME RESPIRATORY CARE LIMITED, UNIT 18, ARKWRIGHT ROAD INDUSTRIAL ESTATE, ARKWRIGHT ROAD, BEDFORD, MK42 0LQ, UNITED KINGDOM
| Authorised Operations |
| MANUFACTURING OPERATIONS (according to part 1) |
| Part 1 - MANUFACTURING OPERATIONS |
| [ 1.2 ] Non-sterile products |
| [ 1.2.1 ] Non-Sterile Products (processing operations for the following dosage forms) |
| [ 1.2.1.7 ] Medicinal gases |
| [ 1.2.2 ] Batch certification |
| [ 1.5 ] Packaging |
| [ 1.5.1 ] Primary packaging |
| [ 1.5.1.7 ] Medicinal gases |
| [ 1.6 ] Quality control testing |
| [ 1.6.3 ] Chemical/Physical |