Medicines and Healthcare products Regulatory Agency
| 1: Authorisation Number | UK MIA 17907 |
|---|---|
| 2: Name of authorisation holder | BRISTOL LABORATORIES LIMITED |
| 3: Address(es) of manufacturing site(s) |
BRISTOL LABORATORIES LIMITED, UNIT 6, SOVEREIGN PARK, LAPORTE WAY, LUTON, LU4 8EL, UNITED KINGDOM BRISTOL LABORATORIES LIMITED, UNIT 5, PREMIER BUSINESS PARK, DENCORA WAY, LUTON, LU3 3HP, UNITED KINGDOM BRISTOL LABORATORIES LIMITED, LAPORTE WAY, LUTON, LU4 8WL, UNITED KINGDOM BRISTOL LABORATORIES LIMITED, UNIT 5, TRAYNOR WAY, WHITEHOUSE BUSINESS PARK, PETERLEE, SR8 2RU, UNITED KINGDOM BRISTOL LABORATORIES LIMITED, UNIT 9A AND 9B, PREMIER BUSINESS PARK, DENCORA WAY, LUTON, LU3 3HP, UNITED KINGDOM BRISTOL LABORATORIES LIMITED, UNIT 3, CANALSIDE, NORTHBRIDGE ROAD, BERKHAMSTED, HP4 1EG, UNITED KINGDOM |
| 4: Legally registered address of authorisation holder | BRISTOL LABORATORIES LIMITED, UNIT 3, CANALSIDE, NORTHBRIDGE ROAD, BERKHAMSTED, HP4 1EG, 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 | 07/11/2024 |
| 9: Annexes attached | Annex 1 and/or Annex 2 |
BRISTOL LABORATORIES LIMITED, UNIT 6, SOVEREIGN PARK, LAPORTE WAY, LUTON, LU4 8EL, UNITED KINGDOM
| Authorised Operations |
| IMPORTATION OF MEDICINAL PRODUCTS (according to part 2) |
| Part 2 - IMPORTATION OF MEDICINAL PRODUCTS |
| [ 2.3 ] Other Importation Activities |
| [ 2.3.1 ] Site of Physical Importation |
BRISTOL LABORATORIES LIMITED, UNIT 5, PREMIER BUSINESS PARK, DENCORA WAY, LUTON, LU3 3HP, UNITED KINGDOM
| Authorised Operations |
| IMPORTATION OF MEDICINAL PRODUCTS (according to part 2) |
| Part 2 - IMPORTATION OF MEDICINAL PRODUCTS |
| [ 2.3 ] Other Importation Activities |
| [ 2.3.1 ] Site of Physical Importation |
BRISTOL LABORATORIES LIMITED, LAPORTE WAY, LUTON, LU4 8WL, 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 products |
| [ 1.2.1 ] Non-Sterile Products (processing operations for the following dosage forms) |
| [ 1.2.1.1 ] Capsules, hard shell |
| [ 1.2.1.8 ] Other solid dosage forms |
| [ 1.2.1.13 ] Tablets |
| [ 1.2.1.17 ] Other non-sterile medicinal products Powders for sachets |
| [ 1.2.2 ] Batch certification |
| [ 1.5 ] Packaging |
| [ 1.5.1 ] Primary packaging |
| [ 1.5.1.1 ] Capsules, hard shell |
| [ 1.5.1.8 ] Other solid dosage forms |
| [ 1.5.1.13 ] Tablets |
| [ 1.5.1.17 ] Other non-sterile medicinal products Powders for sachets |
| [ 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 |
| [ 2.2.2 ] Non-sterile products |
| [ 2.3 ] Other Importation Activities |
| [ 2.3.1 ] Site of Physical Importation |
BRISTOL LABORATORIES LIMITED, UNIT 5, TRAYNOR WAY, WHITEHOUSE BUSINESS PARK, PETERLEE, SR8 2RU, 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 products |
| [ 1.2.1 ] Non-Sterile Products (processing operations for the following dosage forms) |
| [ 1.2.1.1 ] Capsules, hard shell |
| [ 1.2.1.13 ] Tablets |
| [ 1.2.2 ] Batch certification |
| [ 1.5 ] Packaging |
| [ 1.5.1 ] Primary packaging |
| [ 1.5.1.1 ] Capsules, hard shell |
| [ 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 |
| [ 2.1.2 ] Microbiological: non-sterility |
| [ 2.1.3 ] Chemical/Physical |
| [ 2.2 ] Batch certification of imported medicinal products |
| [ 2.2.2 ] Non-sterile products |
| [ 2.3 ] Other Importation Activities |
| [ 2.3.1 ] Site of Physical Importation |
BRISTOL LABORATORIES LIMITED, UNIT 9A AND 9B, PREMIER BUSINESS PARK, DENCORA WAY, LUTON, LU3 3HP, UNITED KINGDOM
| Authorised Operations |
| IMPORTATION OF MEDICINAL PRODUCTS (according to part 2) |
| Part 2 - IMPORTATION OF MEDICINAL PRODUCTS |
| [ 2.3 ] Other Importation Activities |
| [ 2.3.1 ] Site of Physical Importation |
BRISTOL LABORATORIES LIMITED, UNIT 3, CANALSIDE, NORTHBRIDGE ROAD, BERKHAMSTED, HP4 1EG, UNITED KINGDOM
| Authorised Operations |
| IMPORTATION OF MEDICINAL PRODUCTS (according to part 2) |
| Part 2 - IMPORTATION OF MEDICINAL PRODUCTS |
| [ 2.2 ] Batch certification of imported medicinal products |
| [ 2.2.2 ] Non-sterile products |
| [ 2.3 ] Other Importation Activities |
| [ 2.3.1 ] Site of Physical Importation |