5 September 2023

1) CTF

• GML will give an update on the discussions held with the consultancy working with the intensive cares & next steps

2) EHMA Webinar

• Dates for the preparatory call (GML)

3) Policy updates

MoU with FIP
• PGEU MoU to serve as an inspiration for EAHP-FIP MoU
• What would you like to have in the document?

EAHP-EFPIA group on ‘Single Unit Coding’

• No next meeting with EFPIA is foreseen, but if needed, François/EFPIA will reach out to DP to schedule it.
• Internal group – @DKP: do you have any news from your colleagues from DK? Do they want to join the group? If so, this needs to happen asap.
• DP will share EAHP’s proposed wording for the point on sustainability and share the readiness exercise’s main findings with EFPIA
• A new version of the guidance document is being prepared by Paul and there is the objective of having the document finalized by mid-October 2023
• Idea to have the document approved in the EAHP BM in November and in EFPIA BM 2023 in December 2023
• DP will work with AS, DKP and TS on inputs for the roadmap to implement the guidance document
• Internal follow-up actions – DP will keep monitoring the development of these items:
• Contact GS1 – To speak about the possibility of adding an extra-national code in the barcode as a possible intermediate for some countries. It should be checked if this is technically possible. (Tjalling promised to take this up)
• Exchange of Tjalling with the French group representatives (Benjamin)

Revision of EAHP Policy Priorities

• Do you think that the priorities are still updated? Any need for revision?

4) 2024 Congress

PG meetings
• FYI, invitations will go out at the end of this week.

Members meeting agenda
• Which topics would you like to include in it?

• EAHP Shortages survey report & Investigation results
• EAHP Boost event (September 2024), Hospital pharmacy day & state of play ECPhA
• Any outcomes from the meetings with members on the data collection?
• Brief update on EAHP’s financial situation
• Other updates (incl. information on MoUs concluded with other associations and the state of play of the EU’s General Pharmaceutical Legislation)

Past Presidents and Past BMs meeting agenda
• @AS: do you agree that NM chairs this meeting (20/03/2024, 10h30-11h30), since you will have to be in the Partner track at this time (20/03/2024, 11h30-13h)
• Which topics would you like to include in it?

• Updates from EAHP (Shortages survey report, Investigation results, Hospital Pharmacy Day, EAHP Boost event, state of play of ECPhA)
• Other updates (incl. information on MoUs concluded with other associations and the state of play of the EU’s General Pharmaceutical Legislation)

Open items

• @AS: please reply to the email: “Re: EAHP Hospital Pharmacy Statements & FIP Basel Statements Gap Analysis | Survey”
• @AS, DKP: please reply to the email: “RE: URGENT | Single Unit Coding Guideline: wording suggestion”
• @AS, NM: please reply to the email “EAHP Opinion on Unmet Healthcare Needs | draft outline”
• @AS, DKP: please reply to the email “Rough draft – Position Paper on Barcoding”
• @AS, DKP, NM: please reply to the email “EAHP Opinion on Patient Information | draft”
• @AS: please reply to the email “Re: FMD outreach (COM/perm reps) that was planned for the autumn”
• @AS: please reply to the email “FMD Aggregation | Medicines for Europe”
• @DKP: please reply to the email “Re: Barcoding exchange with EFPIA – in the small group” (your plan to reach out to DK (Rikke or Gitte) if one of them wants to join the barcoding group
• @AS, DKP: please reply to the email “Re: Asunto: Re: Opinion on crisis preparedness”

5) Consultations – state of play

Due date	Type of consultation	Action
08/09/2023	Stakeholder consultation on possible outer packaging warning regarding opioid use disorders	Submitted.
10/09/2023	WHO survey | Global stakeholder survey on solutions for strengthening clinical trial infrastructure and capacity	Waiting feedback from the leads (PP/DM)
11/09/2023	CHMP consultation on SmPC section 5.1	Submitted.
15/09/2023	EMA consultation: Call for scientific data for use in HMPC assessment work on Maydis stigma	Leads feedback: not to engage.
15/09/2023	WHO Public consultation on guidance for best practices for clinical trials	DM and PP decided not to engage.
22/09/2023	Survey for the study on mapping and evaluating the implementation of Europe’s Beating Cancer Plan	Lead decided not to engage.
26/09/2023	EMA Draft ICH E6 (R3) guideline on good clinical practice – step 2b	Submitted.
26/09/2023	COM call for evidence | Pharmaceuticals – changes to marketing authorisations (review of EU rules)	Assessment in preparation.
30/09/2023	EMA – draft reflection paper on establishing efficacy based on single arm trials submitted as pivotal evidence in a marketing authorisation	Feedback submitted.
No data is displayed, but the sooner the better, if we decide to engage	“MDR and IVDR Communication Survey”	Shared with the leads
30/09/2023	Furosemide oral solution monograph	Leads provided feedback, drafting the response and will be shared with the leads for approval
30/09/2023	EMA concept Paper on the development of a Guideline on the quality aspects of mRNA vaccines	Submitted.
30/09/2023	EMA Consultation on the International Conference on Harmonisation (ICH) Good Clinical Practice Guideline	EMA leads decided not to engage.
30/09/2023	EMA Consultation: ICH Reflection Paper on proposed international harmonisation of real-world evidence terminology and convergence of general principles regarding planning and reporting of studies using real-world data	EMA leads decided not to engage.
31/10/2023	COM – Revision of the General Pharma Legislation (comments on proposal)	Submitted
31/12/2023	EMA Consultation draft reflection paper on the use of artificial intelligence (AI) in the medicinal product lifecycle	Waiting feedback from the EMA leads

Next policy call? 18 (after 15h), 20 (morning or afternoon before 16h), or 22 (after 15h) September?