Medicines and Healthcare products Regulatory Agency
| 1: Authorisation Number | UK MIA(IMP) 48101 |
|---|---|
| 2: Name of authorisation holder | MAC RESEARCH LTD |
| 3: Address(es) of manufacturing site(s) |
MAC CLINICAL RESEARCH LIMITED - MAC CLINICAL RESEARCH FINANCE LTD, MONARCH HOUSE, WAKEFIELD ROAD, LEEDS, LS10 1DP, UNITED KINGDOM MAC CLINICAL RESEARCH MANCHESTER-MAC CLINICAL RESEARCH FINANCE LIMITED, CITYLABS 1.0, NELSON STREET, MANCHESTER, M13 9NQ, UNITED KINGDOM |
| 4: Legally registered address of authorisation holder | MAC RESEARCH LTD, 19 PARK ROAD, LYTHAM ST. ANNES, FY8 1PW, 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 | 14/10/2024 |
| 9: Annexes attached | Annex 1 and/or Annex 2 |
SCOPE OF AUTHORISATION
Annex 2
Name and address of the site:
MAC CLINICAL RESEARCH LIMITED - MAC CLINICAL RESEARCH FINANCE LTD, MONARCH HOUSE, WAKEFIELD ROAD, LEEDS, LS10 1DP, UNITED KINGDOM
Human Investigational Medicinal Products
| Authorised Operations |
| MANUFACTURING OPERATIONS (according to part 1) |
| 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 |
| [ 1.1.1.4 ] Small volume liquids |
| [ 1.1.1.6 ] Other aseptically prepared products Manipulation of previously formulated products e.g. cytotoxics and monoclonal antibodies, GMOs and vaccines. |
| [ 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 |
| [ 1.2.1.6 ] Liquids for internal use |
| [ 1.2.1.8 ] Other solid dosage forms |
| [ 1.2.1.15 ] Other non-sterile medicinal products Weighing and mixing of drug substance into individual subject dose containers |
| [ 1.2.2 ] Batch certification |
| [ 1.4 ] Other investigational medicinal products or manufacturing activitiy |
| [ 1.4.2 ] Sterilisation of active substances/excipients/finished products: |
| [ 1.4.2.1 ] Filtration |
| [ 1.5 ] Packaging |
| [ 1.5.1 ] Primary packaging |
| [ 1.5.1.1 ] Capsules, hard shell |
| [ 1.5.1.2 ] Capsules, soft shell |
| [ 1.5.1.5 ] Liquids for external use |
| [ 1.5.1.6 ] Liquids for internal use |
| [ 1.5.1.8 ] Other solid dosage forms |
| [ 1.5.1.11 ] Semi-solids |
| [ 1.5.1.13 ] Tablets |
| [ 1.5.1.15 ] Other non-sterile medicinal products Weighing and mixing of drug substance into individual subject dose containers |
| [ 1.5.2 ] Secondary packaging |
| [ 1.6 ] Quality control testing |
| [ 1.6.3 ] Chemical/Physical |
SCOPE OF AUTHORISATION
Annex 2
Name and address of the site:
MAC CLINICAL RESEARCH MANCHESTER-MAC CLINICAL RESEARCH FINANCE LIMITED, CITYLABS 1.0, NELSON STREET, MANCHESTER, M13 9NQ, UNITED KINGDOM
Human Investigational Medicinal Products
| Authorised Operations |
| MANUFACTURING OPERATIONS (according to part 1) |
| Part 1 - MANUFACTURING OPERATIONS |
| [ 1.5 ] Packaging |
| [ 1.5.1 ] Primary packaging |
| [ 1.5.1.1 ] Capsules, hard shell |
| [ 1.5.1.2 ] Capsules, soft shell |
| [ 1.5.1.8 ] Other solid dosage forms |
| [ 1.5.1.13 ] Tablets |
| [ 1.5.2 ] Secondary packaging |