Difference between revisions of "Pharm Tech Minutes 2015.09.16"

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(Discussion on FMD.)
(Discussion on FMD.)
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== Discussion on FMD. ==
 
== Discussion on FMD. ==
# Links by Leonidas:
+
* Links by Leonidas:
* [http://ec.europa.eu/health/files/eudralex/vol-1/dir_2001_83_consol_2012/dir_2001_83_cons_2012_en.pdf Directive]
+
[http://ec.europa.eu/health/files/eudralex/vol-1/dir_2001_83_consol_2012/dir_2001_83_cons_2012_en.pdf Directive]
*[http://www.ema.europa.eu/ema/index.jsp?curl=pages/special_topics/general/general_content_000186.jsp&mid=WC0b01ac058002d4e8 Difference between Falsified and Counterfeit]
+
*[http://ehpb.blogspot.pt/2015/08/european-commission-publishes-draft.html Blog with the summary from EAHP]
+
*[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 Delegated Act]
+
  
# 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.
+
[http://www.ema.europa.eu/ema/index.jsp?curl=pages/special_topics/general/general_content_000186.jsp&mid=WC0b01ac058002d4e8 Difference between Falsified and Counterfeit]
  
# How to address this in IHE
+
[http://ehpb.blogspot.pt/2015/08/european-commission-publishes-draft.html Blog with the summary from EAHP]
#.# 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.
+
[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 Delegated Act]
 +
 
 +
* 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.
  
 
== Next steps ==
 
== Next steps ==

Revision as of 11:07, 16 September 2015

Discussion on FMD.

  • Links by Leonidas:

Directive

Difference between Falsified and Counterfeit

Blog with the summary from EAHP

Delegated Act

  • 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.

Next steps

  • 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.


White Paper

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