Medicines and Healthcare products Regulatory Agency

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 :    

Has been inspected under the national inspection programme in connection with manufacturing authorisation no. UK MIA 42117 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 12/09/2022, 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.

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Operations

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

[ 2.3.2 ] Importation of Intermediate which undergoes further processing

[ 2.3.4 ] Other Semi finish / bulk

Contact Details

04/04/2024	Name and signature of the authorised person of the Competent Authority of United Kingdom
	Confidential
	Medicines and Healthcare products Regulatory Agency
	Tel : Confidential