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10.3 Falsified Medicines Directive

Return to January 2016 Board Agenda here.


A) Relationship to EMVO

Following the considerations of the September Board Meeting in relation to EMVO’s membership offer (more here), a response was sent making clear that the subscription rate suggested was not acceptable, and opening avenues to explore associate membership. Response here.

At the time of writing, a formal response from EMVO to this had not been received. However, informally, I understand that EMVO are minded to amend their subscription suggestion as a result.

UPDATE: EMVO response received on Friday 22 January. To review at Board meeting. Response here. The headline is associate membership is priced at 20,000 euros per year.

Potentially related to this, I have also learned that after an EMVO presentation to the HOPE Board of Directors, HOPE too has rejected a membership offer, again on grounds of cost.

B) Communication with vendors

A teleconference with vendor Arvato is arranged for Tuesday 26 January 1700, and a teleconference with SolidSoft on Wednesday 3 February 1600 CET. 

C) Communications and general

Commission event & European Parliament – Commission event to be held on 26 February. Details here.

To note within this invitation the issue of European Parliament approval of the FMD delegated act. It raises the question of whether EAHP wishes to communicate anything to MEPs about our concerns. Necessarily it would have to urge them to reject the Delegated Act as otherwise the communication is effectively spam. The chances of being successful are close to zero, but it may be an issue of principle/setting on record our concerns. We would not be thanked by the Commission for the effort though.

Germany – The German Hospital Association are seeking exemptions for the hospital sector from the Directive (see section highlighted here)

Sweden – Recent correspondence here.

Austria – December correspondence here.

SecuringIndustry – Interview to be conducted with EAHP on our perspectives of FMD implementation. Important publication in respect of those in the packaging industry. Waiting for interview questions.

In December 2015 a “President’s Letter” was sent to EAHP members urging their engagement at the national level on FMD implementation issues in 2016. Letter here.

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