Medicines and Healthcare products Regulatory Agency

Issued following an inspection in accordance with :

Regulation 5 of the current Veterinary Medicines Regulations

  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 Regulation 5 of The current Veterinary Medicines Regulations

From the knowledge gained during inspection of this manufacturer, the latest of which was conducted on 31/01/2011, it is considered that it complies with

• The principles and guidelines of Good Manufacturing Practice laid down in Regulation 5 of the current Veterinary Medicines Regulations

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

[ 1.1 ] Sterile Products

[ 1.1.1 ] Aseptically prepared (processing operations for the following dosage forms)

[ 1.1.1.2 ] Lyophilisates

[ 1.1.1.4 ] Small volume liquids

[ 1.1.1.6 ] Other aseptically prepared products Emulsions

[ 1.1.2 ] Terminally Sterilised (processing operations for the following dosage forms)

[ 1.1.2.3 ] Small volume liquids

[ 1.1.2.5 ] Other terminally sterilised prepared products Emulsions

[ 1.2 ] Non-sterile products

[ 1.2.1 ] Non-Sterile Products (processing operations for the following dosage forms)

[ 1.2.1.5 ] Liquids for external use

[ 1.2.1.6 ] Liquids for internal use

[ 1.4 ] Other products or manufacturing activity

[ 1.4.2 ] Sterilisation of active substances/excipients/finished products:

[ 1.4.2.1 ] Filtration

[ 1.4.2.3 ] Moist heat

[ 1.6 ] Quality control testing

[ 1.6.1 ] Microbiological: sterility

[ 1.6.2 ] Microbiological: non-sterility

[ 1.6.3 ] Chemical/Physical

Contact Details

09/01/2012	Name and signature of the authorised person of the Competent Authority of United Kingdom
	Confidential
	Medicines and Healthcare products Regulatory Agency
	Tel : Confidential