BREXIT - beappweb.bebeappweb.be/.../03/...meeting-22_02_2019-BREXIT-1.pdf · Brexit preparedness at...
Transcript of BREXIT - beappweb.bebeappweb.be/.../03/...meeting-22_02_2019-BREXIT-1.pdf · Brexit preparedness at...
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BeAPP expert meeting
22 February 2019
BREXIT
Greet Musch
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1. Introduction
On 30/03/2019
the UK becomes a third country
Either
With Withdrawal agreement
Or
Without agreement
Transition period until
31/12/2020
“Hard Brexit”
No transition
period
No ratification
by UK at this
moment
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2. Brexit preparedness at EU Regulatory framework
2.1. EMA
Relocation to Amsterdam :
EMA Business Continuity Planning due to loss of human resources
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2. Brexit preparedness at EU Regulatory framework
2.1. EMA
EMA taskforce on preparedness :
• Redistribution of the UK product portefolio
• New (Co) rapporteurs assigned in April 2018 Human: 5 raps + 8 co-raps for BE
Veterinary: 3 raps + 1 co-rap for BE
• Full responsability taken from the moment UK becomes a 3th country
• Line extensions , Type II variations , PSUR’s and Type 1 variations will already taken over during 2018/early 2019 .
Risk for unavailabilities (shortages): see further
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2. Brexit preparedness at EU Regulatory framework
2.2. Taskforces of national competent authorities
CMDh (& CMDv)
CTFG
HMA Brexit task force
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2. Brexit preparedness at EU Regulatory framework
2.2. Taskforces of national competent authorities
Originally 2325 procedures with UK as RMS to be redistributed
• For 75 % RMS switch completed or agreed
• For 25 % RMS switch still pending
CMDh human medicinal products (MRP_DCP)
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• VHP + with UK as RefNCA was possible till 14 th January 2019
• Redistribution of UK portfolio as ref NCA’s : new ref NCA’s are designated and take over substantial amendments : from 5 th February 2019
• Sponsors encouraged to scrutinise their dossiers : IMPD parts that might be affected by Brexit :
o Change in manufacturer ( import license and at least one QP in EU 27 )
o Change in legal representative ( located in EU 27 )
• For ongoing clinical trials
o QP required in EU 27 ( QC may remain in UK )
o legal representative required in EU 27 ( sponsor may remain in UK ).
2. Brexit preparedness at EU Regulatory framework
2.2. Taskforces of national competent authorities
CTFG (Clinical trials)
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• Analysis on the available capacity in the remaining EU27 member states to take over the UK product portefolio and to handle new application without UK (assessment & inspection).
• Collaboration in the assessment of potential shortages
2. Brexit preparedness at EU Regulatory framework
2.2. Taskforces of national competent authorities
HMA Brexit task force
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2. Brexit preparedness at EU Regulatory framework:
2.3. Legal requirements for PSMF and QPPV
- PSMF and QPPV located in UK must be transferred to EU 27
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2. Brexit preparedness at EU Regulatory framework
2.4. Manufacturing and Supply
Where batch control / release in UK:
Transfer to EU needed before 30/03
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Impact on FAMPH
Impact on FAMHP Redistribution of UK inspections
IWG has made a list, redistribution is ongoing
Manufacturing sites abroad:
For the moment BE has been presented as:
• Lead Supervisory Authority for 24 sites (9MRA, 15 non MRA)
• Supporting Supervisory Authority for 13 sites (5MRA, 8 non MRA)
2. Brexit preparedness at EU Regulatory framework
2.4. Manufacturing and Supply
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Impact on FAMHP Manufacturing sites UK:
• BE should be responsable if batch release happens in BE • For the moment 80 sites are involved
Some batch release sites UK will be transferred to BE
2. Brexit preparedness at EU Regulatory framework
2.4. Manufacturing and Supply
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3. Availability issues
Concerns at EU level and National level:
HMA/EMA Taskforce :
9 th of November 2018: Multi-stakeholder workshop with the Heads of Medicines Agencies / European Medicine Agency task force on availability of authorised medicines
https://www.ema.europa.eu/en/events/multi-stakeholder-workshop-heads-medicines-agencies-european-medicine-agency-task-force-availability
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3. Availability issues
3.1. Centraly Authorised Medecins (CAPs)
• Identification of medicines potentially at risk:
o MAH is located in UK
o Batch Control (QC) site, Batch release (BR)site and/or Importation site is located in the UK
o Qualified Person for Pharmacovigilance (QPPV) or the Phamacovigilance System Master File (PSMF) is located in UK
• Concerned MAHs were questioned on their planning for transfer of activities.
• Analysis of therapeutic use & therapeutic alternatives by CHMP
• Survey to authorities of Member States
• Limited number of medicines still considered at risk (situation is followed from day to day)
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3. Availability issues
3.2. MRPs and DCPs
CMDh (Human Medicinal Products)
o No common list of essential products
o CMDh survey in November 2018 (21/27 responses)
o 95% of the responders identified medicinal products with autorized entities in UK or conducted any other analysis to identify medecines that could be risk of shortage due to Brexit
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3.2. MRPs and DCPs
What about BE? (HMPs) o Identification of commercialised medicinal products with
authorised entities only in UK
o Identification of those products for which an alternative with the same active substance and dosage form is available
o Evaluation about criticality and potential therapeutic alternatives
o MAHs contacted and asked for planning of their activities
o Evaluation of the responses received
3. Availability issues
Very small number of medicines at risk
Contineous follow-up
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4. Brexit preparedness at EU Regulatory framework : MDR/IVD
- Recast MDR / IVD foreseen to be implemented 2020 / 2022 respectively
- Criticalities on NB exists already today and impact of Brexit will worsen the situation : 5 NB in UK will no longer be able to issue CE certificates for EU
- 30-40 % of market authorisations of medical technologies have been performed by UK NB and are to be transfered to EU 27 NB
- Need for legal representative in EU 27
- Need for availability of essential medical technologies , while safeguarding the safety of the patients
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5. Brexit preparedness at EU Regulatory framework: Blood / Cells and tissues
• Blood rarely exchanged
• Replacement tissue need to be imported from third countries in EU by authorised importing establishments.
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Resources for MP activities:
VHBPRE (additional RMS ships): 1 fte A1
R&D (additional VHP , SA for CTA’s ): 1 fte A1
1 fte B
VET (national variations): 1 fte B for 1 year
ASS (assessment of doss int clients): 4,5 fte A2
VHBPOST (RMS switches): 1 fte A1
1 fte A2
0,5 fte B
VIG (additional PRAC RAPships): 3 fte A2
1 fte A1
DGI (GVP, GCP, GMP): 8,2 fte A2
6. Resources needed in case of hard Brexit
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Resources for MedDev activities:
R&D (additional clin invest): 1 fte A1
Health products (several activities): 1 fte A1
VIG (materiovigilance): 1 fte A1
DGI (meddev): 2 fte A2
6. Resources needed in case of hard Brexit
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7. Brexit preparedness at national level :
Conclusions
• Impact assessment on activities at famhp level is performed and optimised
• Capacity and training needs of HR @ famhp are estimated
• Solidarity approach in taking up our responsability in the EU regulatory framework and take over part of the additional workload as a consequence of Brexit
• Part of the national task force : Lead by Foreign Affairs
• Communication in preparation for citizens , patients and stakeholders
• Focus on availability of essential medicinal products , medical technologies and health products
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Thank you for your attention
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Contact
Federaal Agentschap voor Geneesmiddelen en Gezondheidsproducten - FAGG
Victor Hortaplein 40/40
1060 BRUSSEL
tel. + 32 2 528 40 00 fax + 32 2 528 40 01
e-mail [email protected]
www.fagg.be
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Uw geneesmiddelen en gezondheidsproducten, onze zorg