Medicines and Healthcare products Regulatory Agency

MANUFACTURER'S AUTHORISATION
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
Authorised Operations
IMPORTATION OF MEDICINAL PRODUCTS (according to part 2)
Operations
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).