Welcome and opening remarks Presented by Olga Solomon, Head of - - PowerPoint PPT Presentation

Industry Stakeholder meeting on Brexit and operation of the centralised procedure for human medicinal products

Welcome and opening remarks

Presented by Olga Solomon, Head of Unit, DG SANTE B5, Medicines: policy, authorisation and monitoring on 20 April 2018

UK's w ithdraw al from the EU

Main ongoing work strands:

• - Withdrawal agreement ("Article 50 agreement")
• - "Transition period" (part of the "Article 50

agreement")

• - "Future relationship"

Bottom-line: UK will be a "third country" on 30/ 3/ 19

W ithdraw al agreem ent

• - "Winding down" of EU membership
• Draft text has been published, the EU and the UK have

agreed, at negotiators' level, on the colour-coded text, indicating areas of agreement, disagreement or where further clarifications are needed.

• The withdrawal agreement needs to be ratified by both

sides.

• The Heads of State or Government of the EU27 to evaluate
• n 23 March at the European Council (Article 50) the state
• f play of the negotiations
• The EP will also evaluate the progress.

"Transition period" ( i)

• - Full acquis applies to the UK
• Dynamic reference, i.e. including acquis that starts

applying in the transition period

• No UK participation in EU institutions or EU bodies
• No UK participation in Member State meetings

(subject to exceptions)

• No UK role as "leading authority"
• Full role of Court of Justice, Commission, Court of

Auditors, etc.

"Transition period" ( ii)

• -
• Duration: until 31 December 2020 (incl.)
• Agreement still needs to be negotiated, agreed,

and ratified

• !! Do not rely on the "transition period" !!

Future uture econom

• nomic re

relati ations nshi hip

UK re red lin lines:

• Independent

trade policy. UK re red lin lines:

• No ECJ

jurisdiction;

• Regulatory

autonomy. UK re red lin lines:

• No free

movement;

• No substantial

financial contribution;

• Regulatory

autonomy. UK re red lin lines:

• No ECJ

jurisdiction;

• No free

movement;

• No substantial

financial contribution;

• Regulatory

autonomy. UK leaves es the he EU EU

No

• deal

al

Brexi xit – Next steps ps

Sufficie icient prog

• gress
• Citiz

tizens

• Ireland

nd

• Fina

nanci ncial al s settl.

Dec.

• ec. 20

2017 Europe pean an Counc ncil

Withdrawal awal (Art. 50)

Pur Pursui uit of

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negotiation

• ns +

+ dr drafting of

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thdrawal Agr greement nt wi with UK

Pre repara rato tory talks s at t EU27 27

Nego egoti tiations on

• n tr

trans ansition n wi with UK Prepa parat ator

• ry

tal alks at at EU2 EU27 Sco Scoping of

• f futur

future rel relat ations wi with UK Ratificat cation

Marc rch 2018 2018 Eur Europ

• pean

an Counc

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Oct.

• Oct. 20

2018 Europe

• pean

an Counc ncil Ma

• Mar. 2019

UK b become mes s 3rd count

• untry

Pha Phase 2 e 2 Pha Phase 1 e 1

Trans nsition

• n (Art. 50)

Futur ure relat ation

• n

Ne Negot

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• n

futur ure relat ations

• ns

wi with h UK

Politi tica cal decl clarati tion

Jan 2018 2018 Gen. . Affai airs Counc

• uncil

Trans nsition

• n

period

"Brexit preparedness"-m edicinal products

• Notice to m arketing authorisation holders of centrally

authorised m edicinal products for hum an and veterinary use

• http: / / www.ema.europa.eu/ docs/ en_GB/ document_library/ Ot

her/ 2017/ 05/ WC500226603.pdf

• Q&As related to the United Kingdom 's w ithdraw al from the

European Union w ith regard to the m edicinal products for hum an and veterinary use w ithin the fram ew ork of the Centralised Procedure

• https: / / ec.europa.eu/ health/ sites/ health/ files/ files/ documents

/ qa_on_brexit.pdf

Other areas for "Brexit preparedness"

• I ntellectual property: Protection granted by EU

trademarks and designs will no longer apply to the UK

• Value-added tax ( VAT) : Rules change from "intra

Community supply" to those for EU import/ export

• Medical devices placed on the market after Brexit

require a certificate of a EU-27 notified body

• The shipment of certain chemicals to the UK (a "third

country") may become subject to additional permits under sectorial legislation

• Commission departments have published "notices to

stakeholders" on these and other aspects: https: / / ec.europa.eu/ info/ brexit/ brexit-preparedness_en

"Brexit preparedness"-m edicinal products

MAHs need to consider timely to adapt processes and changes to the terms of the marketing authorisation e.g.:

• MAHs, MAAs and sponsors of orphan designations need to

be established in the EU ( EEA)

• QPPV reside and carry out tasks in EU ( EEA) . PSMF

located in EU.

• Batch control, batch release site need to be located in the

EU ( EEA)

• Thank you !