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GS1 Healthcare Newsletter Page 6
GS1 Healthcare Newsletter
Page 6 of 13 pages
GS1 Healthcare Newsletter
No. 24 – Spring / Summer – 2012 - www.gs1.org/healthcare/news_events
Sanofi Pasteur launches 2D bar
coding for paediatric vaccines
The American Academy of Pediatrics (AAP) and Sanofi
Pasteur, the vaccines division of Sanofi, recently announced
the adoption of 2D barcodes including lot numbers and
expirations dates to improve patient care and office
efficiencies. The new technology is meant to reduce medical
errors and provide better visibility across the supply chain
by documenting vaccine information in patient records with
greater accuracy.
The 2D bar-code technology is available because of the work
by a collaborative group of stakeholders and the forward
thinking of many AAP members, says Edward Zissman, MD,
FAAP, co-chair of the AAP Vaccine Barcoding project.
Other vaccine manufacturers are expected to begin
launching products with 2D bar codes later in the year.
Food and Drug Administration (FDA) guidance allows
manufacturers to request a linear barcode waiver to use
alternative symbologies such as the GS1 DataMatrix. A US
Centers for Disease Control and Prevention (CDC) pilot with
two manufacturers will be implemented in approximately
223 immunizer practices from August 2012 to April 2013.
Europe: Public consultation of the
EU concept paper for the delegated
acts
The European Commission published in November 2011 a
concept paper for public consultation in preparation for the
delegated act on the detailed rules for a Unique Identifier
for medicinal products for human use, and its verification
as required by Directive 2011/62/EU. The consultation
ended on 27 April 2012. GS1 in Europe and GS1 Healthcare
submitted a joint contribution to this public consultation in
which GS1 applauded the European Commission and the
European Parliament for its ongoing commitment to increase
the security of the pharmaceutical supply chain and prevent
the entry into the legal supply chain of falsified medicinal
products. In particular, as the European Commission moves
forward, GS1 Healthcare recommended a harmonised
approach across the European Union, and even worldwide,
as well as the adoption of GS1 Standards by the European
Commission, providing a framework to fulfil the needs of
various applications, including authentication/verification as
required by Directive 2011/62/EU.
GS1 also encouraged setting a framework for the industry,
which will allow it to move towards the use of GS1 Standards
across the European Union by 2022, by mandating that all
systems be able to use GS1 Standards.
Algeria: GS1 DataMatrix endorsed
for Pharma products serialisation
GS1 DataMatrix has been
incorporated in the new Algerian
proposal on legal requirements for
Pharma serialisation. As from mid-
March 2012, the Ministry of Health,
together with relevant stakeholders,
will draft a Roadmap to provide
guidance to the industry on implementing GS1 DataMatrix.
The new legal requirements on Pharma serialisation
including the incorporation of GTIN, Batch Number, Expiry
Date and Serial Number, into the GS1 DataMatrix bar code,
for all medicines are expected to be adopted by end 2012
/ early 2013.
Updated information on this topic will be provided within
the GS1 Healthcare Public Policy Work Team and via the
Public Policy Database (GS1 Healthcare Members only.
To become a Global Member: http://www.gs1.org/
healthcare/about/memberships
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