Difference between revisions of "Pharm Tech Minutes 2015.09.16"

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

Latest revision as of 12:08, 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