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Falsified Medicines Directive – April 2019

Since our last policy update in February the following meetings were attended:

5th February – EMVO Press Conference Preparation meeting
8th February – EMVO Press Conference
18th February – call with DG SANTE, NCAs and EMVO Stakeholders
25th February – call with DG SANTE, NCAs and EMVO Stakeholders
27th February – EMVO Stakeholder Meeting
8th March – call with DG SANTE, NCAs and EMVO Stakeholders
14th March – EMVO Board meeting
15th March – EMVO Statutory General Assembly
20th March – call with DG SANTE, NCAs and EMVO Stakeholders

Implementation readiness of the HP sector

During the FMD meeting at Congress the large majority of attendees reported that all hospital pharmacies are connected to the national system. Only France, Ireland and Portugal have reported implementation problems. In France, only 40% of hospitals are connected. In Portugal 19 out of the 112 entities are connected. Public hospitals in Ireland are still missing scanning equipment. All member countries have reported high numbers of alerts. These are however tolerable at the moment since they can be ignored. DK shared a guidance document with SK which could be shared in a shortened version with all of EAHP’s member countries.

Calls with COM, NCAs and EMVO Stakeholders

The European Commission has been organising regular calls to exchange with EMVO, EMVO Stakeholders and national competent authorities (NCAs) about the progress at national level. Focus was put on the updates from EMVO concerning the technical problems of the hub. Industry did not have any issues to report, apart from the fact that they were suffering from the technical issues of the hub and misconfigured end user scanners/software. EAHP, PGEU and GIRP stressed the importance of lowering alerts and of uploading missing data to the hub. The calls will continue to be organised.

EMVO

The main topics for EMVO are the following:

  • URS revision of all volumes;
  • Alert handling

The TEAG (technical working group, a HOPE representative is a member on behalf of the hospital sector) is supposed to revise all 7 Volumes of the URS. The revision has been delayed due to the technical issues with the hub during the first few weeks after the implementation of FMD. Issues were raised by EFPIA and GRIP because their representatives do not report back information.

The European Commission has stressed the importance of finding solutions for alert handling. EMVO is currently looking into setting up a system that could help NMVOs manage alerts better.

EP event – 19 February

The European Alliance for Access to Safer Medicines (EAASM) has produced a report after the EU Parliament meeting on FMD that brought together experts to support knowledge sharing and best practices around processes and authentication in the hospital sector. The report is available HERE.

FMD – request from the CZ association to conduct a short survey on aggregation

Martin Simicek spoke with PH about the possibility to conduct a short survey on aggregation. Given that implementation, the way how the national authorities see their role and how they approach aggregation very much differs from country to country ,the Czech Board thought that it might be useful to conduct a short survey with one response per country that would describe and show these differences and provide information to our member associations that could be used when talking to authorities about aggregation. The Board leads agree with this suggestion. Practicalities still need to be discussed.

FMD serialisation webinar

Given the discussions at EMVO’s Statutory General Assembly linked to aggregation, the FMD serialisation webinar has been put on hold. Next steps should be discussed, in particular the need for alignment of standards and how this can be achieved in parallel to the discussions with EMVO and the other EMVO stakeholders on aggregation.

2019 GA – FMD policy document

The draft FMD policy document will be prepared after the Board meeting. It will contain information on the most important EMVO developments and EAHP’s engagement between June 2018 and April 2019. The document will be shared with the FMD Board leads for review.

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EAHP Forum

All the EAHP team is working on providing a Forum that can help connect all the members in Conversations and Groups to talk about important matters for the European Hospital Pharmacist.

The Forum will be accessible for all the EAHP members, you don’t have to create a new account to browse and participate.

Conversations and groups

The Conversations will be moderated by our team to provide documents and relevant topics for the community.

The Groups will connect all members that share a category. Members who work on the same assocation, on the same hospital, that have the same role, etc.

Stay tuned for the realase of the forum. Soon on EAHP.