From now on, UNICOM will feature bi-monthly interactive webinar sessions organized by UNICOM workpackage (WP) 1 “IDMP-related standards and terminologies.” We wish to provide a wider public access to the UNICOM Community of Expertise and discuss current IDMP topics and further issues related to the identification of medicinal products in regulatory and clinical contexts. The webinars will be complemented by an extensive questions and comments section. Issues discussed will support UNICOM to enrich its “Gap-Analysis” helping to identify open and new issues around the IDMP suite of standards and their implementation.
The first session topic was:“IDMP, Falsified Medicines Directive and Parallel Trade.” Moderated by UNICOM WP lead Christian Hay, Jean-Gonzague Fontaine, member of ISO TC215/WG6 “Pharmacy and Medication – IDMP Sustainability Strategy Lead at GlaxoSmithKline – was the presenter. The one-hour session talked about the role of IDMP standards and others like the GS1 Global Trade Item Number (GTIN) standard in the context of protecting European and global citizens from falsified medicinal products. As core element of the data matrix code, the GTIN number is now mandatory for each package distributed in Europe.
“Parallel Trade” of medicinal products within the European Union is another application field with different decommissioning and repackaging techniques across EU Member States. This repackaging requires tight control of distribution channels and the original medicines involved. Parallel trade is part of the EU Single Market and the implied free movement of goods.
The web discussion attracted almost 60 participants who advanced some hot questions for discussion . One of those related to the relationship between the regulatory and the supply chain domains. The European rules refers to a unique identifier as one of the measures to fight against medicinal product falsification. This identifier is in the vast majority of the Member States the GTIN with a serial number. But the regulatory domain is built on the IDMP standards, which includes a “Data Carrier Identifier”. How can the two domains interact in the case of parallel trade, when regulations require a change of the GTIN, and how to link this to the IDMP domain? The slides of this webinar will be soon available for reference under the menu ‘UNICOM Resources’.
The next webinar and interactive session is planned on Friday 4 September, 3-4 pm CEST with a focus on definition, governance and attributes to be employed for calculating a globally unique identification for pharmaceutical products (PhP) as defined by IDMP, the PhPID. The session will be jointly presented by:
Malin Flavad – WHO Uppsala Monitoring Centre, Sweden
Leonora Grandia – Z-Index, Netherlands
Giorgio Cangioli – HL7 Europe
November: UNICOM Pilot Product List
December: IDMP and COVID-19
January: EMA SPOR Implementation Guide v2
The webinars are open to every interested person but prior registration is compulsory.