Medicines and Healthcare products Regulatory Agency
| 1: Authorisation Number | UK MIA(IMP) 57623 |
|---|---|
| 2: Name of authorisation holder | CHARLES RIVER DISCOVERY RESEARCH SERVICES UK LIMITED |
| 3: Address(es) of manufacturing site(s) |
CHARLES RIVER DISCOVERY RESEARCH SERVICES UK LIMITED, STEPHENSON BUILDING, THE SCIENCE PARK, KEELE, NEWCASTLE, ST5 5SP, UNITED KINGDOM |
| 4: Legally registered address of authorisation holder | CHARLES RIVER DISCOVERY RESEARCH SERVICES UK LIMITED, STEPHENSON BUILDING, THE SCIENCE PARK, KEELE, NEWCASTLE, ST5 5SP, 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 | 13/03/2023 |
| 9: Annexes attached | Annex 1 and/or Annex 2 |
SCOPE OF AUTHORISATION
Annex 2
Name and address of the site:
CHARLES RIVER DISCOVERY RESEARCH SERVICES UK LIMITED, STEPHENSON BUILDING, THE SCIENCE PARK, KEELE, NEWCASTLE, ST5 5SP, 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) |
| [ 1.1.1.4 ] Small volume liquids |
| [ 1.2 ] Non-sterile investigational medicinal products |
| [ 1.2.1 ] Non-Sterile Products (processing operations for the following dosage forms) |
| [ 1.2.1.6 ] Liquids for internal use |
| [ 1.2.1.15 ] Other non-sterile medicinal products Manufacture of low bioburden bulk drug substance solutions. |
| [ 1.3 ] Biological investigational medicinal products |
| [ 1.3.1 ] Biological medicinal products |
| [ 1.3.1.2 ] Immunological products |
| [ 1.3.1.4 ] Gene therapy products |
| [ 1.3.1.5 ] Biotechnology products |
| [ 1.3.1.8 ] Other biological medicinal products Antibodies, antibody conjugates Live microbial products; Therapeutic Virus; Plant extracted materials. |
| [ 1.4 ] Other investigational medicinal products or manufacturing activitiy |
| [ 1.4.2 ] Sterilisation of active substances/excipients/finished products: |
| [ 1.4.2.1 ] Filtration |
| [ 1.4.2.3 ] Moist heat |
| [ 1.6 ] Quality control testing |
| [ 1.6.2 ] Microbiological: non-sterility |
| [ 1.6.3 ] Chemical/Physical |
| [ 1.6.4 ] Biological |
| Part 2 - IMPORTATION OF MEDICINAL PRODUCTS |
| [ 2.1 ] Quality control testing of imported medicinal products |
| [ 2.1.2 ] Microbiological: non-sterility |
| [ 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 |
| [ 2.2.3.2 ] Immunological products |
| [ 2.2.3.3 ] Cell therapy products |
| [ 2.2.3.4 ] Gene therapy products |
| [ 2.2.3.5 ] Biotechnology products |
| [ 2.2.3.6 ] Human or animal extracted products |
| [ 2.2.3.8 ] Other biological medicinal products Antibodies, antibody conjugates Live microbial products; Therapeutic Virus; Plant extracted materials. |