Pharm Tech Minutes 2015.09.16
Discussion on FMD.
- Links by Leonidas:
[Directive http://ec.europa.eu/health/files/eudralex/vol-1/dir_2001_83_consol_2012/dir_2001_83_cons_2012_en.pdf] [Difference between Falsified and Counterfeit http://www.ema.europa.eu/ema/index.jsp?curl=pages/special_topics/general/general_content_000186.jsp&mid=WC0b01ac058002d4e8] [blog with the summary from EAHP http://ehpb.blogspot.pt/2015/08/european-commission-publishes-draft.html] [Delegated Act http://ec.europa.eu/growth/tools-databases/tbt/en/search/?tbtaction=get.project&Country_ID=EU&num=306&dspLang=EN&basdatedeb=,&basdatefin=&baspays=EU&baspays2=EU&basnotifnum=306&basnotifnum2=306&bastypepays=EU&baskeywords=&project_type_num=2&project_type_id=1&lang_id=EN ]
- Discussion: scanning of all items is not practical and poses problems. These problems introduced by the FMD can be minimized or resolved by having proper interoperability like IHE recommends.
- How to address this in IHE
- .# Add a few paragraphs to whitepaper
- .# Create a new "educational" paper - as agreed in Chania - with the topic "falsified medicines directive…" to explain how IHE addresses some of the challenges, or how the work in IHE gives arguments to the ongoing discussion.
- Work group is defining (until 25 September) the content of this new paper. Also adding some content if it is feasible.
- Then the work group will raise this matter to the Pharmacy committee to decide Go/NoGo with the publication of such document.
- Meanwhile Jose will ask Mary if this off-cycle publication is possible by IHE.
Current version is on FTP site: whitepaper (Under revision, read at your own risk...)
- Jose will notify the group that a new version of the whitepaper is available