22 November 2021

1) CTF

Meeting with DG GROW

• DG GROW provided feedback (see below in italics). SK and GML will outline during the policy call how these point could be addressed.

  “Unfortunately we will not be able to host a meeting in the nearest future due to other obligations.

  However, in you work towards a CTF for hospital pharmacists I would like to stress the following points;

  Your submission needs to clearly demonstrate that a CTF would enable more professionals to move across borders – i.e. evidence that the current framework is not functioning properly and that a CTF would increase mobility. We have to this point very little to no complaints about the situation for hospital pharmacists and therefore the mobility aspect is crucial.
  It must show that the professionals are not covered by automatic recognition. In this regards I would especially place focus on C-167/90 where the European Court of Justice made clear that the activities of a hospital pharmacist are not very different from the ones of a pharmacist “d’officine”(open to the public).
  I would also highlight especially art.45.3 in the Professional Qualifications Directive (PQD) and that the activities of hospital pharmacists are not covered by this list. The same importance should also be placed on art.49(a).2 PQD. All these conditions must be met before we can start an assessment for a CTF.”

Steering Committee/WG chair – involvement desire

• GML will give an update on scheduling a call with the Steering Committee/WG chairs to discuss their commitment.

2) Policy updates

FIP exchanges & next meetings

• European Regional meeting (16 November): @ AB how was the meeting?

EPHA – General Assembly

• EPHA’s GA will take place on 7th of December (see agenda HERE).
• During the meeting new Board members will be elected. Do you have any suggestions who we should vote for? (Darina Sedlakova (ECL) | Alice Chapman-Hatchett (NHS) | Anca Toma (SFP) | Claudia Marinetti (MHE) | Denis Onyango (EATG) | Edward De Beukelaer (EUROCAM) | Esther-Mary D’Arcy (ER WPT) | Florence Berteletti (Eurocare) | Tadeusz Jedrzejczyk (PSHP))

Open issues – linked to emails shared in the past 2 weeks

• SK will go with AS, AB and PH through all open issues for which no response was provided by email by 22nd November.

3) Board meeting follow-up & Congress

President’s guest invitations

• SK will give another update during the call about the responses received so far. 

Meeting with past Board members at congress + invitation of past Presidents

• Please see HERE the list of past Board members that are being invited to congress. Due to the 50th anniversary also the past Presidents (see list HERE) are being invited.

Guidance document – board country visits/engagement with Board countries

• SK will share the draft with AS in the week of 22nd November.

EAHP Award

• SK, AS and PH will provide an update on the discussion to AB during the call.

4) Consultations – state of play

Due date	Type of consultation	Action
08/12/2021	EMA consultation: ICH guideline M7 on assessment and control of DNA reactive (mutagenic) impurities in pharmaceuticals to limit potential carcinogenic risk – addendum.	Feedback request shared with entire Board.
17/12/2021	EMA consultation: Guideline on computerised systems and electronic data in clinical trials	Feedback request shared with entire Board.
20/12/2021	EMA – ICH guideline Q13 on continuous manufacturing of drug substances and drug products – Step 2b	Feedback request shared with entire Board.
21/12/2021	COM – Public Consultation: Revision of the EU general pharmaceuticals legislation	SK is updating the draft response in accordance with information received during call with leads.

Next policy call – Monday 6th December, Tuesday 7th December or Thursday 9th December?