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BeAPP expert meeting
22 February 2019
BREXIT
Greet Musch
2
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
3
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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
5
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
6
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)
8
• 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)
9
• 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
10
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
11
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
12
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
13
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
14
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
15
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)
16
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
17
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
18
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.
20
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
21
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
22
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
23
24
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 welcome@fagg.be
www.fagg.be
Uw geneesmiddelen en gezondheidsproducten, onze zorg
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