Medicines and Healthcare products Regulatory Agency
| 1: Authorisation Number | UK MIA(IMP) 39 |
|---|---|
| 2: Name of authorisation holder | UCB PHARMA LIMITED |
| 3: Address(es) of manufacturing site(s) |
UCB PHARMA LIMITED, 208 BATH ROAD, SLOUGH, SL1 3WE, UNITED KINGDOM |
| 4: Legally registered address of authorisation holder | UCB PHARMA LIMITED, 208 BATH ROAD, SLOUGH, SL1 3WE, 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 | 22/07/2022 |
| 9: Annexes attached | Annex 1 and/or Annex 2 |
SCOPE OF AUTHORISATION
Annex 2
Name and address of the site:
UCB PHARMA LIMITED, 208 BATH ROAD, SLOUGH, SL1 3WE, UNITED KINGDOM
Human Investigational Medicinal Products
| Authorised Operations |
| IMPORTATION OF MEDICINAL PRODUCTS (according to part 2) |
| Part 2 - IMPORTATION OF MEDICINAL PRODUCTS |
| [ 2.2 ] Batch certification of imported medicinal products |
| [ 2.2.2 ] Non-sterile products |
| [ 2.3 ] Other Importation Activities |
| [ 2.3.4 ] Other Importation of QP-certified IMPs from a country on the approved country for import list |
Any restrictions or clarifying remarks
QP Valentine Hecq is included on this licence solely for the oversight of imported IMPs following certification in an approved country in accordance with the provisions of Regulation 43(1) of UK SI 2004/1031 (as amended). Valentine Hecq may not undertake QP certification of other activities performed under this MIA(IMP).