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 in connection with marketing authorisation(s) listing manufacturers located outside of the European Economic Area in accordance with The Human Medicines Regulations 2012 (SI 2012/1916)

From the knowledge gained during inspection of this manufacturer, the latest of which was conducted on 18/08/2015, 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

1. MANUFACTURING OPERATIONS

[ 1.3 ] Biological medicinal products

[ 1.3.1 ] Biological medicinal products

[ 1.3.1.6 ] Human or animal extracted products

[ 1.3.1.8 ] Other biological medicinal products Harvest of egg white that contains active substance (i.e., sebelipase alfa)

Contact Details

26/10/2015	Name and signature of the authorised person of the Competent Authority of United Kingdom
	Confidential
	Medicines and Healthcare products Regulatory Agency
	Tel : Confidential