Medicines and Healthcare products Regulatory Agency
| 1: Authorisation Number | UK MIA(IMP) 12689 |
|---|---|
| 2: Name of authorisation holder | PAREXEL INTERNATIONAL LIMITED |
| 3: Address(es) of manufacturing site(s) |
PAREXEL INTERNATIONAL LIMITED, CLINICAL PHARMACOLOGY RESEARCH UNIT, LEVEL 7, NORTHWICK PARK HOSPITAL, WATFORD ROAD, HARROW, HA1 3UJ, UNITED KINGDOM |
| 4: Legally registered address of authorisation holder | PAREXEL INTERNATIONAL LIMITED, C/O LAWRENCE YOUNG LIMITED, HART HOUSE, PRIESTLEY ROAD, BASINGSTOKE, RG24 9PU, 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 | 06/12/2023 |
| 9: Annexes attached | Annex 1 and/or Annex 2 |
SCOPE OF AUTHORISATION
Annex 2
Name and address of the site:
PAREXEL INTERNATIONAL LIMITED, CLINICAL PHARMACOLOGY RESEARCH UNIT, LEVEL 7, NORTHWICK PARK HOSPITAL, WATFORD ROAD, HARROW, HA1 3UJ, UNITED KINGDOM
Human Investigational 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 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 |
| [ 1.1.3 ] 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 |
| [ 1.2.2 ] Batch certification |
| [ 1.3 ] Biological investigational medicinal products |
| [ 1.3.2 ] Batch certification |
| [ 1.3.2.5 ] Biotechnology products |
| [ 1.4 ] Other investigational medicinal products or manufacturing activitiy |
| [ 1.4.1 ] Manufacture of: |
| [ 1.4.1.3 ] Other Assemble and Import closed containers of cytostatics/cytotoxics, where there will be minimal risk of exposure/ Importation of QP certified IMPs from a country on the approved country for import list |
| [ 1.5 ] Packaging |
| [ 1.5.1 ] Primary packaging |
| [ 1.5.1.1 ] Capsules, hard shell |
| [ 1.5.1.2 ] Capsules, soft shell |
| [ 1.5.1.3 ] Chewing gums |
| [ 1.5.1.5 ] Liquids for external use |
| [ 1.5.1.6 ] Liquids for internal use |
| [ 1.5.1.9 ] Pressurised preparations |
| [ 1.5.1.11 ] Semi-solids |
| [ 1.5.1.12 ] Suppositories |
| [ 1.5.1.13 ] Tablets |
| [ 1.5.2 ] Secondary packaging |
| Part 2 - IMPORTATION OF MEDICINAL PRODUCTS |
| [ 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 |
| [ 2.3 ] Other Importation Activities |
| [ 2.3.1 ] Site of Physical Importation |
| [ 2.3.2 ] Importation of Intermediate which undergoes further processing |
| [ 2.3.4 ] Other Assemble and Import closed containers of cytostatics/cytotoxics, where there will be minimal risk of exposure/ Importation of QP certified IMPs from a country on the approved country for import list |