Medicines and Healthcare products Regulatory Agency
1: Authorisation Number | UK MIA(IMP) 13101 |
---|---|
2: Name of authorisation holder | LABCORP CLINICAL RESEARCH UNIT LIMITED |
3: Address(es) of manufacturing site(s) |
LABCORP CLINICAL RESEARCH UNIT LIMITED, SPRINGFIELD HOUSE, HYDE STREET, LEEDS, LS2 9LH, UNITED KINGDOM |
4: Legally registered address of authorisation holder | LABCORP CLINICAL RESEARCH UNIT LIMITED, SPRINGFIELD HOUSE, HYDE STREET, LEEDS, LS2 9LH, 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 | 23/12/2021 |
9: Annexes attached | Annex 1 and/or Annex 2 |
SCOPE OF AUTHORISATION
Annex 2
Name and address of the site:
LABCORP CLINICAL RESEARCH UNIT LIMITED, SPRINGFIELD HOUSE, HYDE STREET, LEEDS, LS2 9LH, 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 |
[ 1.1.1.4 ] Small volume liquids |
[ 1.1.1.6 ] Other aseptically prepared products Formulation/Reconstitution of biologicals and peptide hormones with subsequent manufacture of small |
[ 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 |
[ 1.2.1.8 ] Other solid dosage forms |
[ 1.2.1.15 ] Other non-sterile medicinal products Radiolabelled substances e.g. liquids, solid dosage forms and capsules |
[ 1.3 ] Biological investigational medicinal products |
[ 1.3.1 ] Biological medicinal products |
[ 1.3.1.8 ] Other biological medicinal products Packaging of immunological and biotechnology products. Packaging of human or animal extracted produc |
[ 1.4 ] Other investigational medicinal products or manufacturing activitiy |
[ 1.4.1 ] Manufacture of: |
[ 1.4.1.3 ] Other Radiolabelled substances e.g. e.g. liquid and solid dosage forms./Importation of QP-certified IMPs f |
[ 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 |
[ 1.5.1.3 ] Chewing gums |
[ 1.5.1.4 ] Impregnated matrices |
[ 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 |
[ 1.5.1.12 ] Suppositories |
[ 1.5.1.13 ] Tablets |
[ 1.5.1.14 ] Transdermal patches |
[ 1.5.2 ] Secondary packaging |
[ 1.6 ] Quality control testing |
[ 1.6.3 ] Chemical/Physical |
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 |
[ 2.2.3.2 ] Immunological products |
[ 2.2.3.5 ] Biotechnology products |
[ 2.2.3.6 ] Human or animal extracted products |
[ 2.3 ] Other Importation Activities |
[ 2.3.1 ] Site of Physical Importation |
[ 2.3.4 ] Other Radiolabelled substances e.g. e.g. liquid and solid dosage forms./Importation of QP-certified IMPs f |