Medicines and Healthcare products Regulatory Agency
| 1: Authorisation Number | UK MIA(IMP) 15134 |
|---|---|
| 2: Name of authorisation holder | OWEN MUMFORD LIMITED |
| 3: Address(es) of manufacturing site(s) |
OWEN MUMFORD LIMITED, PRIMSDOWN INDUSTRIAL ESTATE, WORCESTER ROAD, CHIPPING NORTON, OX7 5XP, UNITED KINGDOM |
| 4: Legally registered address of authorisation holder | OWEN MUMFORD LIMITED, BROOK HILL, WOODSTOCK, OX20 1TU, 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 | 27/04/2023 |
| 9: Annexes attached | Annex 1 and/or Annex 2 |
SCOPE OF AUTHORISATION
Annex 2
Name and address of the site:
OWEN MUMFORD LIMITED, PRIMSDOWN INDUSTRIAL ESTATE, WORCESTER ROAD, CHIPPING NORTON, OX7 5XP, 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 |
| [ 1.2 ] Non-sterile investigational medicinal products |
| [ 1.2.1 ] Non-Sterile Products (processing operations for the following dosage forms) |
| [ 1.2.1.15 ] Other non-sterile medicinal products Combination Adrenaline autoinjector |
| [ 1.5 ] Packaging |
| [ 1.5.1 ] Primary packaging |
| [ 1.5.1.15 ] Other non-sterile medicinal products The combination autoinjector is assembled, labelled and packed by Owen Mumford Ltd. The bulk sterile prefilled syringe is supplied separately and is assembled into the combination product using in-house manufactured plastic components |
| [ 1.5.2 ] Secondary packaging |
| [ 1.6 ] Quality control testing |
| [ 1.6.3 ] Chemical/Physical |
| Part 2 - IMPORTATION OF MEDICINAL PRODUCTS |
| [ 2.3 ] Other Importation Activities |
| [ 2.3.2 ] Importation of Intermediate which undergoes further processing |