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PHARMACEUTICAL INSPECTION CONVENTION PHARMACEUTICAL INSPECTION CO-OPERATION SCHEME

3 December 2007

PRESS RELEASE

PIC/S MEETINGS IN SINGAPORE

From 18 to 23 November 2007, the following events took place in Singapore: PIC/S Executive Bureau, PIC/S Committee, annual PIC/S Seminar, PIC/S – ASEAN forum and PIC/S – ISPE joint workshop. It is the first time that PIC/S meetings (including the annual PIC/S Seminar) have taken place in Asia!

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PIC/S COMMITTEE MEETING (19 November 2007)

A joint Committee meeting of the Pharmaceutical Inspection Convention (PIC) and the Pharmaceutical Inspection Co-operation Scheme (PIC Scheme) was held in Singapore on 19 November 2007 under the chairmanship of Mr. Jacques Morénas (France / French Agency for the Safety of Health Products). With the exception of Austria, Belgium, Iceland and Liechtenstein, all PIC/S Participating Authorities were represented. The competent authorities from Argentina, Israel, Malta and USA, as well as EMEA and WHO also participated in the meeting.

The Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme (jointly referred to as PIC/S) are two international instruments between countries and pharmaceutical inspection authorities which provide together an active and constructive co-operation in the field of GMP. Their purpose is the networking between competent authorities, the development and maintenance of mutual confidence, the exchange of information and experience in the field of GMP and related areas and the mutual training of inspectors.

There are currently 31 Participating Authorities in the PIC/S (Convention (#) and Scheme taken together). The PIC/S Participating Authorities are coming from Australia#, Austria#, Belgium#, Canada, Czech Republic (both Human and Veterinary), Denmark#, Estonia, Finland#, France#, Germany#, Greece, Hungary#, Iceland#, Ireland#, Italy#, Latvia, Liechtenstein#, Malaysia, Netherlands, Norway#, Poland, Portugal#, Romania#, Singapore, Slovak Republic, South Africa, Spain, Sweden#, Switzerland#, and the United Kingdom#.

Assessment and Reassessment of Authorities Argentina and Malta to join in 2008

The Committee invited Argentina’s National Institute of Medicaments (INAME) and Malta’s Medicines Authority (MMA) to join PIC/S as new Participating Authorities as of 1 January 2008. INAME applied for PIC/S Membership on 26 January 2005 and has been admitted following an assessment of its GMP system (notably the GMP inspectorate, the manufacturer

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