Medicines and Healthcare products Regulatory Agency
| 1: Authorisation Number | UK MIA(IMP) 41042 |
|---|---|
| 2: Name of authorisation holder | ABBVIE LTD |
| 3: Address(es) of manufacturing site(s) |
ABBVIE LIMITED, ABBVIE HOUSE, VANWALL BUSINESS PARK, VANWALL ROAD, MAIDENHEAD, SL6 4UB, UNITED KINGDOM |
| 4: Legally registered address of authorisation holder | ABBVIE LTD, ABBVIE HOUSE, VANWALL BUSINESS PARK, VANWALL ROAD, MAIDENHEAD, SL6 4UB, 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 | 24/01/2024 |
| 9: Annexes attached | Annex 1 and/or Annex 2 |
SCOPE OF AUTHORISATION
Annex 2
Name and address of the site:
ABBVIE LIMITED, ABBVIE HOUSE, VANWALL BUSINESS PARK, VANWALL ROAD, MAIDENHEAD, SL6 4UB, UNITED KINGDOM
Human Investigational Medicinal Products
| Authorised Operations |
| IMPORTATION OF MEDICINAL PRODUCTS (according to part 2) |
| Part 2 - IMPORTATION OF MEDICINAL 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
Mr Alessandro Giuseppe Giunta, Dr Ralph Deubner, Mrs Cathrin Pauly, Mr Kevin Regan, Dr Christian van den Bos and Mr Philipp Kindel are 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). Mr Alessandro Giuseppe Giunta, Dr Ralph Deubner, Mrs Cathrin Pauly, Mr Kevin Regan, Dr Christian van den Bos and Mr Philipp Kindel may not undertake QP certification of other activities performed under this MIA(IMP).