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

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

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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 welcome@fagg.be

www.fagg.be

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