22 June 2023

1) CTF

Meeting with DG GROW
• DG Grow’s letter & next steps

Meeting with other professional organisations
• We are still waiting for the response of DG GROW)
• Inclusion of other professional organisation (e.g., we just contacted laboratory medicine specialists).

2) Hospital Pharmacy Day
• GML to ask AS how to move forward with the trademark (and create a logo) and if EAHP should approach other associations outside Europe to get them on board with this and in general next steps on this.

2) Policy updates 

EMA
• Following up on the annual meeting with EMA, we need examples to share/support the EAHP call for the density information on the SmPC

EDQM
• @NM to give feedback from the EDQM stakeholder meeting that took place on 20 June and share any possible follow-up activities

FIP
• AS to report back from the “Council Engagement” call that he joined on 27 May.
• FIP update on statement feedback submission: feedback on the different draft policy statements submitted

Gravitate Health
• AS to share his comments on the draft letter from Ilaria (document attached)

GS1
• Points to raise in the upcoming exchange with GS1
o How GS1’s work is going regarding patient identification standard?

GS1 shared they would like to discuss 

– Next World Patient Safety Day (WPSD) joint campaign
– GS1 Healthcare Conference Sao Paulo – EAHP participation

EAHP-EFPIA group on ‘Single Unit Coding’
• EAHP internal group discussion on 29 June (12h-13h CEST)
o Feedback was asked by 28 June on some questions related to the national preparedness regarding the use of single-unit dose barcoding. @AS, DKP: do not forget to reply.
• Intermediate meeting before the end of June: François/EFPIA proposed Wednesday, 28 June (in the afternoon) or Friday, 30 June (in the morning). @DKP: what time does fit you better?
o @AS, DKP: what should EAHP discuss at this meeting? How is the collection of information on the capabilities of industry members and the feasibility of having a human-readable format?

NCODA
• Creation of the agenda for the meeting on 10/07: how could we set out collaboration and on which terms? Discussion on having a pilot phase where NCODA shares some materials for oncology medicines in all languages and EAHP disseminates?

Open items
• @AS, NM: to provide feedback on the document on EDQM Traceability of Medicines in Hospital by 27 June

4) Consultations – state of play

Due date	Type of consultation	Action
28/06/2023	EMA – Consultation on the revision of the transparency rules of the Clinical Trials Information System (CTIS)	Draft feedback sent to PP, waiting for her feedback.
30/06/2023	EDQM – Clonidine hydrochloride oral solution monograph	EAHP feedback submitted.
3/07/2023	European Commission – DG SANTE: Study supporting the report to the European Parliament and to the Council on trends in the falsification of medicinal products and measures provided according to Directive 2011/62/EU	Waiting CP feedback.
14/07/2023	CIOMS Working Group XIII report on Real-World Data and Real-World Evidence in Regulatory Decision Making	Summary & Assessment in preparation
24/07/2023	CIOMS Benefit-Risk Balance for Medicinal Products	Summary & Assessment in preparation
31/07/2023	EMA – concept paper on revision of the Guideline on clinical investigation of medicinal products in the treatment of patients with acute respiratory distress syndrome.	PP feedback: not to engage.
16/08/2023	COM – Revision of the General Pharma Legislation (comments on proposal)	Drafting will start after exchanges with BMs.
30/09/2023	EMA – draft reflection paper on establishing efficacy based on single arm trials submitted as pivotal evidence in a marketing authorisation	PP decided to engage but SK is still waiting for her feedback on the document.

Next policy call? 10 (before 15h30) or 11 (except 12h-13h) July?