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Medicines and Healthcare products Regulatory Agency

CERTIFICATE NUMBER : UK MIA 101 Insp GMP/GDP/IMP 101/19062596-0008[H]

Certificate of GMP Compliance Of A Manufacturer(1),(2)

Part 1
Issued following an inspection in accordance with :

Regulation 331A of The Human Medicines Regulations 2012 (SI 2012/1916)

  The competent authority of United Kingdom confirms the following :
The Manufacturer : NOVARTIS PHARMACEUTICALS UK LIMITED
 
Site address : NOVARTIS PHARMACEUTICALS UK LIMITED, 2ND FLOOR, THE WEST WORKS BUILDING, WHITE CITY PLACE, 195 WOOD LANE, LONDON, W12 7FQ, UNITED KINGDOM
 

Has been inspected under the national inspection programme in connection with manufacturing authorisation no. UK MIA 101 in accordance with Regulation 17 of The Human Medicines Regulations 2012 (SI 2012/1916)

From the knowledge gained during inspection of this manufacturer, the latest of which was conducted on 08/03/2021, it is considered that it complies with
  • The principles and guidelines of Good Manufacturing Practice laid down in Regulation B17 of the Human Medicines Regulations 2012 (as amended)

This certificate reflects the status of the manufacturing site at the time of the inspection noted above and should not be relied upon to reflect the compliance status if more than three years have elapsed since the date of that inspection. However, this period of validity may be reduced or extended using regulatory risk management principles by an entry in the Restrictions or Clarifying remarks field. This certificate is valid only when presented with all pages and both Parts 1 and 2. The authenticity of this certificate may be verified in MHRA-GMDP. If it does not appear, please contact the issuing authority.

  • (1) Guidance on the interpretation of this template can be found in the Help menu of MHRA-GMDP database.
  • (2) These requirements fulfil the GMP recommendations of WHO.
Part 2
Human Medicinal Products
  1. MANUFACTURING OPERATIONS
  [ 1.1 ] Sterile Products
    [ 1.1.3 ] Batch certification
  [ 1.2 ] Non-sterile products
    [ 1.2.2 ] Batch certification
  [ 1.3 ] Biological medicinal products
    [ 1.3.2 ] Batch certification
      [ 1.3.2.5 ] Biotechnology products
  2. IMPORTATION OF MEDICINAL PRODUCTS
  [ 2.2 ] Batch certification of imported medicinal products
    [ 2.2.1 ] Sterile Products
      [ 2.2.1.1 ] Aseptically prepared
      [ 2.2.1.2 ] Terminally sterilised
    [ 2.2.2 ] Non-sterile products
  [ 2.3 ] Other Importation Activities
    [ 2.3.4 ] Other
Ordering and Invoicing of all products, including those imported from outside of the EEA
Restrictions or Remarks
The certificate is issued based on a remote inspection of GMP compliance during COVID-19 travel restrictions. A risk-based site inspection programme remains in force.
08/04/2021 Name and signature of the authorised person of the Competent Authority of United Kingdom
Confidential
Medicines and Healthcare products Regulatory Agency
Tel : Confidential

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