Medicines and Healthcare products Regulatory Agency
| 1: Authorisation Number | UK MIA 14988 |
|---|---|
| 2: Name of authorisation holder | MELBOURN SCIENTIFIC LIMITED |
| 3: Address(es) of manufacturing site(s) |
MELBOURN SCIENTIFIC LIMITED, SAXON WAY, MELBOURN, ROYSTON, SG8 6DN, UNITED KINGDOM |
| 4: Legally registered address of authorisation holder | MELBOURN SCIENTIFIC LIMITED, SAXON WAY, MELBOURN, ROYSTON, SG8 6DN, 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 | 20/11/2024 |
| 9: Annexes attached | Annex 1 and/or Annex 2 |
SCOPE OF AUTHORISATION
Annex 1
Name and address of the site:
MELBOURN SCIENTIFIC LIMITED, SAXON WAY, MELBOURN, ROYSTON, SG8 6DN, UNITED KINGDOM
Human Medicinal Products
| Authorised Operations |
| MANUFACTURING OPERATIONS (according to part 1)IMPORTATION OF MEDICINAL PRODUCTS (according to part 2) |
| Part 1 - MANUFACTURING OPERATIONS |
| [ 1.1 ] Sterile Products |
| [ 1.1.3 ] Batch certification |
| [ 1.2 ] Non-sterile products |
| [ 1.2.1 ] Non-Sterile Products (processing operations for the following dosage forms) |
| [ 1.2.1.17 ] Other non-sterile medicinal products Nasal spray emulsion, Soft mist for inhalation |
| [ 1.2.2 ] Batch certification |
| [ 1.6 ] Quality control testing |
| [ 1.6.3 ] Chemical/Physical |
| [ 1.6.4 ] Biological |
| Part 2 - IMPORTATION OF MEDICINAL PRODUCTS |
| [ 2.1 ] Quality control testing of imported medicinal products |
| [ 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 |
| [ 2.2.3 ] Biological medicinal products |
| [ 2.2.3.5 ] Biotechnology products |
| [ 2.2.3.6 ] Human or animal extracted products |
| [ 2.2.3.8 ] Other biological medicinal products This variation in support of an MA appliction for Enoxoparin which is derived from porcine sources. |