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Medicines and Healthcare products Regulatory Agency

CERTIFICATE NUMBER : UK MIA(IMP) 37245 Insp IMP 37245/14726845-0009[I]

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

Part 1
Issued following an inspection in accordance with :

Part 6 of The Medicines for Human Use (Clinical Trials) Regulations 2004 (SI 2004/1031)

  The competent authority of United Kingdom confirms the following :
The Manufacturer : MYONEX LIMITED
 
Site address : MYONEX LIMITED, 1 MEER END, BIRSTALL, LEICESTER, LE4 3EH, UNITED KINGDOM
 

Has been inspected under the national inspection programme in connection with manufacturing authorisation no. UK MIA(IMP) 37245 in accordance with Part 6 of The Medicines for Human Use (Clinical Trials) Regulations 2004 (SI 2004/1031)

From the knowledge gained during inspection of this manufacturer, the latest of which was conducted on 21/10/2021, 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 Investigational Medicinal Products
  1. MANUFACTURING OPERATIONS
  [ 1.1 ] Sterile Investigational Medicinal Products
    [ 1.1.3 ] Batch certification
  [ 1.2 ] Non-sterile investigational medicinal products
    [ 1.2.2 ] Batch certification
  [ 1.3 ] Biological investigational medicinal products
    [ 1.3.2 ] Batch certification
      [ 1.3.2.2 ] Immunological products
      [ 1.3.2.5 ] Biotechnology products
      [ 1.3.2.6 ] Human or animal extracted products
  [ 1.5 ] Packaging
    [ 1.5.2 ] Secondary packaging
  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
    [ 2.2.3 ] Biological medicinal products
      [ 2.2.3.2 ] Immunological products
      [ 2.2.3.5 ] Biotechnology products
      [ 2.2.3.6 ] Human or animal extracted products
  [ 2.3 ] Other Importation Activities
    [ 2.3.1 ] Site of Physical Importation
    [ 2.3.4 ] Other
Importation of QP certified IMPs from a country on the 'approved country for import list'
Restrictions or Remarks
Secondary packaging activities on site limited to open label studies and expiry update / post-certification labelling activity only.
22/10/2021 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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