The founding principle of the ESM approach is that each pack of medicine is checked individually before it is dispensed to the patient, ensuring that the patient receives a genuine product. The system will support the use of GS1 Standards (GS1 DataMatrix containing GTIN, Expiration Date, Batch or Lot Number and Serial Number) and PPN. Dave Ricks, Senior VP and President Lilly Bio-Medicines and EFPIA board member said that “the announcement marks an important milestone in the development of a pan-European system to effectively combat counterfeit medicines. Patient safety is paramount for the European Stakeholder Model partners. This is why we are proactively investing to build the first elements of a medicines verification system for Europe. Working in partnership with governments, we intend to deliver a system that is robust, secure and cost-effective.” Although still in the formative stage, the not-for-profit stakeholder organisation, called the European Medicines Verification Organisation (EMVO) will oversee the ESM. The system is planned to be also composed by so-called blue-print systems, that can be rolled-out in a cost-effective manner on a national level. Read more
Brazil - ANVISA issues a public consultation on identification and tracking of pharmaceutical products ANVISA published its public consultation on pharma serialisation. The proposal is to include a GS1 DataMatrix comprised of a national number provided by ANVISA, Serial Number and Expiration Date, and Batch or Lot Number. The new requirements are intended to be applicable 180 days after the publication of the final rule. GS1 Brazil and GS1 Healthcare provided a joint answer to the public consultation on 9 May and suggested that ANVISA use the truly global GS1 System also in Brazil. This approach was supported by the Brazilian stakeholders. The input was acknowledged in a public meeting and the final rule is expected in the next weeks.
Saudi Arabia - Saudi FDA publishes a guidance document for pharmaceuticals The Drug Sector in Saudi Food and Drug Authority (SFDA) believes that a standardised identification system for drugs from the manufacturer to the patient is imperative to comply with the increasing need for product integrity and traceability. The responsible department of the Saudi FDA is therefore urging all drug manufacturers in Saudi Arabia and international manufacturers exporting to Saudi Arabia to adopt GS1 supply chain standards. All drugs’ markings must be upgraded from linear bar codes to GS1 DataMatrix bar codes. The GS1 DataMatrix bar code must, at minimum, carry the GTIN (Global Trade Item Number), Expiration Date, Batch or Lot Number. The new requirements must be applied by drug manufacturers on all type of pharmaceutical products (both human and veterinary drugs).
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The SFDA published a circular stating the dates of implementation in two phases: • Use of 2D bar codes with Batch or Lot Number, Expiration Date and SFDA code will be due on the 21 March 2015 • All of the above plus a Serial Number due on the 21 March 2016.
GS1 Healthcare Newsletter No. 27 – Q2 2013 - http://www.gs1.org/healthcare/library#newsletters
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