Medicines and Healthcare products Regulatory Agency
1: Authorisation Number | UK MIA 45438 |
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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 |
IMPORTATION OF MEDICINAL PRODUCTS (according to part 2) |
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 |