Medicines and Healthcare products Regulatory Agency

MANUFACTURER'S AUTHORISATION
1: Authorisation Number UK MIA 45438
2: Name of authorisation holder 3M UNITED KINGDOM PUBLIC LIMITED COMPANY
3: Address(es) of manufacturing site(s)

KINDEVA DRUG DELIVERY LIMITED , DERBY ROAD, LOUGHBOROUGH, LE11 5SF, UNITED KINGDOM

4: Legally registered address of authorisation holder 3M UNITED KINGDOM PUBLIC LIMITED COMPANY, 3M CENTRE, CAIN ROAD, BRACKNELL, RG12 8HT, 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 27/02/2020
9: Annexes attached Annex 1 and/or Annex 2
SCOPE OF AUTHORISATION
Annex 1
Name and address of the site:

KINDEVA DRUG DELIVERY LIMITED , DERBY ROAD, LOUGHBOROUGH, LE11 5SF, UNITED KINGDOM

Human Medicinal Products
Authorised Operations
Authorised Operations
IMPORTATION OF MEDICINAL PRODUCTS (according to part 2)
Operations
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
[ 2.2 ] Batch certification of imported medicinal products
    [ 2.2.2 ] Non-sterile products
[ 2.3 ] Other Importation Activities
    [ 2.3.4 ] Products authorised under regulation 174 (supply in response to spread of pathogenic agents etc)
        No physical importation; fiscal movement of product between 3M EMEA Switzerland and 3M UK PLC