10 December 2020

1) CTF

Activity update

• Steering Committee – an update will be shared with the committee as soon as GML obtains feedback from France and Spain about the registration of their specialisation.
• WG 1 – The the template piloted by Portugal was shared with the the countries with an HP specialisation and those working on establishing one.
• WG 3 – Input is currently collected on the FAQs until 11 December.
• Registration of specialisation – GML is continuing to follow up with specialisation countries to track their progress. Belgium has registered the specialisation. Spain and France had an exchanges with the person responsible for the registration. A call with Austria remains to be organised (they don’t have time at the moment).

2) Policy updates

European Commission Study on the profession of Pharmacists

• The Spark network invited PH to provide input to their study on the revision of the pharmacy provisions in the Professional Qualifications Directive (see emails HERE). SK has put together some input (see HERE) based on the discussions with PGEU, EPSA, EIPG and EAFP (see HERE). @ PH – how would you like to proceed? As mentioned in my email, AB and PP should also be involved since they were active in the discussions with PGEU, EPSA, EIPG and EAFP.

Medical Devices

• Board portfolio: @ PH – Can I approach DM to start the process of introducing her as a replacement for AS in the Commissions device group?
• EuroPharmat: @ AB – do you agree with NM’s suggestion to hold a call with EuroPharmat to speak with them about the position paper on medical devices and the work that has been done by EAHP in the Commission’s medical device sub-groups?

COVID-19 vaccines

• Vaccine overview: GML has updated the document (see HERE)
• Vaccine Opinion: SK has put together a draft opinion (see HERE)
• EMA: information published by EMA on the COVID-19 vaccines could also be useful (see HERE).
• NEW EMA public COVID event: TS will be talking on behalf of EAHP and PGEU. He will touch on the importance of vaccine registration for pharmacovigilance and linking the vaccines to patients. 

FMD – aggregation exchange

• @ AS – when would you be available for an exchange with France? Options include: 15th December – after 5 PM CET | 16th December – in the afternoon | 17th December – after 2 PM | 18th December – after 1 PM | 22nd December – in the afternoon | 23rd December – in the afternoon.

President’s Guests 2021

• @ PH – do you have any comments on the President’s Guest list before the invitations go out? See draft invitation text (HERE) and see guest list (HERE).

Inception Impact Assessment – Blood, tissue and cells

• A very brief statement (see HERE) touching on the shortages of plasma-derived medicines was put together. @PH, AB, AS – do you have anything to add?

Starting work on MoU with PGEU

• The letter was sent. Ilaria mentioned in another conversation that she will come back shortly concerning our meeting request.

NEW – FIP Vaccination Series (summary event)

• SK will get to summarise the discussion items from the European round she moderated. Are there any specific HP points, apart from those that we have in our opinion, that you would me to make? I will also check with NM. Since the European round was very dominated by community pharmacists views, I want to get also the voice of the HP heard in the summary event.

3) Consultations – state of play

Due date	Type of consultation	Action
14/12/2020	Inception Impact Assessment – Blood, tissues and cells for medical treatments & therapies – revised EU rules	Checking input with PH, AS and AB
14/12/2020	Roadmap consultation – Demographic change in Europe – green paper on ageing	Collecting feedback from leads (AS, NM and PP).
31/12/2020	Guideline on registry-based studies	TS and DM are providing input.
31/12/2020	EDQM – Issue 2 of Pharmeuropa PaedForm	PP commented and input from SA is requested.
06/01/2020	Roadmap – Medicines for children & rare diseases – updated rules	GML is currently putting together a response.
13/01/2021	EMA – Draft guideline on the clinical investigation of human normal immunoglobulin for intravenous administration (IVIg)	Checking relevance with TS and DM.
02/02/2021	Proposal for a Regulation on a Union framework addressing public health emergencies (EMA)	Will be discussed with EMA leads
02/02/2021	Proposal for a Regulation establishing a European Centre for Disease Prevention and Control (ECDC)	Will be discussed with infectious disease leads
02/02/2021	Proposal for a Regulation on serious cross-border threats to health	Will be discussed with all relevant leads

Next policy call – Before Christmas? 22nd or 23rd December