Medicines and Healthcare products Regulatory Agency
| 1: Authorisation Number | UK MIA 13485 |
|---|---|
| 2: Name of authorisation holder | MW ENCAP LIMITED |
| 3: Address(es) of manufacturing site(s) |
MW ENCAP LIMITED, UNITS 1-8, OAKBANK PARK WAY, OAKBANK INDUSTRIAL ESTATE, MID CALDER, LIVINGSTON, EH53 0TH, UNITED KINGDOM |
| 4: Legally registered address of authorisation holder | MW ENCAP LIMITED, UNITS 1-8, OAKBANK PARK WAY, OAKBANK INDUSTRIAL ESTATE, MID CALDER, LIVINGSTON, EH53 0TH, 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 | 23/03/2023 |
| 9: Annexes attached | Annex 1 and/or Annex 2 |
SCOPE OF AUTHORISATION
Annex 1
Name and address of the site:
MW ENCAP LIMITED, UNITS 1-8, OAKBANK PARK WAY, OAKBANK INDUSTRIAL ESTATE, MID CALDER, LIVINGSTON, EH53 0TH, UNITED KINGDOM
Human 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 products |
| [ 1.2.1 ] Non-Sterile Products (processing operations for the following dosage forms) |
| [ 1.2.1.1 ] Capsules, hard shell |
| [ 1.2.1.17 ] Other non-sterile medicinal products Larger scale manufacture of Cytotoxics in dedicated high containment facilities. Initial dispensing of drug substance is carried out in an isolation cabinet. Packaging: Strip and/or blister packing |
| [ 1.3 ] Biological medicinal products |
| [ 1.3.1 ] Biological medicinal products |
| [ 1.3.1.6 ] Human or animal extracted products |
| [ 1.5 ] Packaging |
| [ 1.5.1 ] Primary packaging |
| [ 1.5.1.1 ] Capsules, hard shell |
| [ 1.5.1.17 ] Other non-sterile medicinal products Cytotoxics |
| [ 1.6 ] Quality control testing |
| [ 1.6.2 ] Microbiological: non-sterility |
| [ 1.6.3 ] Chemical/Physical |
| Part 2 - IMPORTATION OF MEDICINAL PRODUCTS |
| [ 2.1 ] Quality control testing of imported medicinal products |
| [ 2.1.3 ] Chemical/Physical |
| [ 2.2 ] Batch certification of imported medicinal products |
| [ 2.2.2 ] Non-sterile products |
| [ 2.3 ] Other Importation Activities |
| [ 2.3.2 ] Importation of Intermediate which undergoes further processing |