This presentation was delivered during the “go-home-meeting” hosted by Pharmakon on Sept 9th, 2020. We shared our insights and thoughts on the impact of Brexit on medicinal products – in the pre-and post-approval phase, from the EU and the UK perspective.

1. 1
Velkommen
1

2. 22
How to overcome the regulatory
challenges due to
BREXIT
9 September 2020
09/09/20

3. 33
Kulminder Nowacki - Director of Regulatory
Science Drugs and Biologics at VCLS
Barbara Christensen – Senior Regulatory Science
Specialist at IWA Consulting
Who are we?
The VCLS Family:
+200 life sciences professionals providing Regulatory Science Services to privat and
public clients within Biotech, Pharma and Medtech.

4. 44
To share with others the knowledge/experiences we have gained together with our
clients throughout the past few years
Brexit is a ”super-hot subject” - MHRA Brexit guidances recently withdrawn and
being replaced by updated guidance (+20 guidance documents published within
last 1-2 weeks)
We are currently studying the updated guidance in more detail. The process of
gaining a thorough understanding of all implications is ongoing. Some guidance
still pending → We don’t have all the answers
Why this meeting? What to expect?

5. Brexit - Current Status
January 31, 2020
• The UK stopped being a member of EU and became a third country.
December 31, 2020
• The transition period will come to an end by December 2020
• During the transition period UK will continue to follow EU’s rules
From 01 January 2021 onwards...
• If a trade deal has been agreed and ratified:
• The UK will either start a new relationship with the EU
• Or exit the transition period without a trade deal
Negotiations are still ongoing between UK Government and EU Commission,
details yet to be defined

6. Challenges facing EU, UK and Pharma Industry
• Brexit is a big question mark for everybody including the
Pharmaceutical Industry, we can see that EU Commission, Member
States and of course the UK government face challenges to find a
compromise on the main topics
• Each industry –not only Pharmaceutical- is facing these
challenges given there is still no clear guidance/agreement at least
on some key aspects between EU and UK
• The Pharmaceutical Industry hopes there will be a sense of
reciprocity in the procedures between EU and UK, meaning UK will
not impose something deleterious to EU and conversely EU will not
impose something that is impossible for the UK to meet.
• If UK Government and consequently MHRA is forced to adopt
stringent requirements, thus setting the bar too high for drug
developers, Applicants may deprioritize UK in their development
and registration plans.

8. 88
Consequences of Hard Brexit on Life
cycle management

9. 99
eCTD Dossier Split – MRP/DCP
Current UK licenses are valid as they are issued at national level.
Future variations to be submitted via MHRA portal via National procedure.
eCTD dossier to be converted into GB MA Dossier.
Resubmission of current documents via MHRA portal – 4 options:
1) Start a completely new lifecycle and reference to the existing MRP
sequences.
2) Reuse all existing MRP sequences to UK to continue new lifecycle.
3) Clone all existing sequences as a new set for UK.
4) Create a baseline from “current view”.
Detailed guidance is still pending!

10. 1010
eCTD Dossier Split – CP
MAH Obligations of converted EU MAs:
• 1 year to submit (starting on exit day) initiating sequence
• Initiating sequence must reflect only what is relevant for GB
• Single, technically valid eCTD sequence 0000 of the converted EU MA
• There is no fee for the grandfathering process but an annual service fee
• Must include all currently approved information that has previously been
submitted in the eCTD format
• Two-step process possible - minimal initiating sequence containing at least
the mandatory documents at an early point following 1 January 2021.
The date on which the minimal or full initiating sequence is received is
referred to as “the data submission date”.
Submission package (defined in MHRA GU):
Cover letter, declaration, Summary of historical regulatory activities, Initial
MAA eAF, Launch status in UK, Common EN 1.3.1, etc.

11. 1111
CP - ongoing variations/renewals
Submission Type Positive Opinion
before exit day
Include in Initiating
Sequence
Type IA
Submitted before exit day and not rejected
N/A Yes
Type IB
Submitted but not granted before exit day
Yes/No Yes
Type II
Submitted but not granted before exit day
Yes Yes
Type II before or in clock stop
Submitted but not granted before exit day
No No
Type IB/II variations
Submitted to EMA after exit day
N/A No
Renewal before or in clock stop
Submitted but not granted before exit day
No No
Renewal
Submitted but not granted before exit day
Yes Yes

12. 1212
CP - ongoing new MAAs
Ongoing MAAs expecting approval after the end of the
transition period, the…
• QPPV,
• PSMF,
• Batch release site,
• Batch control sites and
• local representatives for Member States (other than
UK) must be located in the Union/EEA
Changes to be made during the procedure!
Documents to be submitted as part of Response to
Day 120 or Day 180!