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Brexit & the Life sciences

Find out what Brexit means for you and your company

Who are We

At Freyr

Freyr is a leading, niche, full-service global Regulatory Solutions and Services Company supporting, Large, Medium and Small size global Life sciences companies:

  • Pharmaceutical
  • Generics
  • Medical Device
  • Biotechnology
  • Biosimilar
  • Consumer Healthcare
  • Cosmetics
  • Chemicals

In their entire Regulatory value-chain; ranging from Regulatory Strategy, Intelligence, Dossiers, Submissions etc. to Post-Approval/Legacy Product Maintenance, Labeling, Artwork Change Management and other related functions.

Freyr Regulatory Expertise in the United Kingdom (UK)

  • Strategic Regulatory Consulting
  • Regulatory Roadmap for Market Access
  • Regulatory Affairs & Regulatory Intelligence
  • Registration Pathways and License Management Services
  • Market Authorizations (MAA)
  • End-To-End Operational Support
  • Regulatory Submission Guidance and Preparation
  • 510(K) Submissions
  • Dossier Preparation, Review and Management
  • GLP, GCP
  • Pharmacovigilance
  • Safety Reports
  • CE Marking
  • Patient Information Leaflet (PIL) and Summary of Product Characteristics Services
  • Regulatory Labeling
  • In-Country Representation

    Your business operations are

  • If you're a UK Entity

    If you have HQ/RnD/Manufacturing in the UK, you face the most exposure to Brexit.

  • If you're an EU Entity with UK presence

    You need to monitor changes to know if you need to transfer technology and human resource inside the EU and ensure your International Regulatory framework is in capable hands as Market authorisations are going to change.

  • International Entity

    Your major concerns will be - Monitoring Regulatory changes and Labeling/Artwork to ensure products hit shelves as soon as possible. You will need to approach EU and UK as separate markets for regulatory strategies.

You want to know
the Impact on

  • Submit necessary variations e.g. Artwork/Labeling/Packaging
  • Representative Entity needed in EEA MRP/DCP National /Central Procedure
  • Can EU Citizens be recruited for trials
  • Sponsors Need Legal Representatives in the EU
  • Loss of Access to EU Clinical Trial Portal and Database
  • EU (QPPV) based in EEA
  • PSMF will legally have to reside in the Union (EEA)
  • Compliance to changes in GMP guidelines (if any)
  • Movement of goods affected Tariff/Non-Tariff barriers
  • Movement of Resources Resource (RnD personnel, representative for Clinical Trial Authorisation) needs to move to EU/EEA

Possible Scenarios for a UK entity

Submit
necessary
variations e.g.
Artwork/
Labeling/
Packaging

No extension to transition and no trade deal

Yes

No extension and a basic trade deal

Yes

A short extension

No

A longer extension and a trade deal

Yes

EEA member (Like Norway)

Yes

Customs Union (Turkey)

Yes

(Australia Type) worldwide fta- basis WTO

Yes

Bilateral Option (Swiss)

Yes

WTO rules, only-MFN with EU

Yes

Ukraine Option

Yes

Possible Scenarios for a UK entity

Representative
Entity needed
in EEA
MRP/DCP
National/
Central Procedure

No extension to transition and no trade deal

Yes*

No extension and a basic trade deal

Yes

A short extension

No

A longer extension and a trade deal

Yes

EEA member (Like Norway)

Yes

Customs Union (Turkey)

Yes

(Australia Type) worldwide fta- basis WTO

Yes

Bilateral Option (Swiss)

No

WTO rules, only-MFN with EU

No

Ukraine Option

No

Possible Scenarios for a UK entity

Can EU Citizens be recruited for trials

No extension to transition and no trade deal

No

No extension and a basic trade deal

No

A short extension

No

A longer extension and a trade deal

Yes

EEA member (Like Norway)

Yes

Customs Union (Turkey)

Yes

(Australia Type) worldwide fta- basis WTO

No

Bilateral Option (Swiss)

Yes

WTO rules, only-MFN with EU

No

Ukraine Option

No

Possible Scenarios for a UK entity

Sponsors Need Legal Representatives in the EU

No extension to transition and no trade deal

Yes

No extension and a basic trade deal

Yes

A short extension

No

A longer extension and a trade deal

No

EEA member (Like Norway)

No

Customs Union (Turkey)

No

(Australia Type) worldwide fta- basis WTO

Yes

Bilateral Option (Swiss)

No

WTO rules, only-MFN with EU

Yes

Ukraine Option

Yes

Possible Scenarios for a UK entity

Loss of Access to EU Clinical Trial Portal and Database

No extension to transition and no trade deal

Yes

No extension and a basic trade deal

Yes

A short extension

No

A longer extension and a trade deal

No

EEA member (Like Norway)

No

Customs Union (Turkey)

No

(Australia Type) worldwide fta- basis WTO

Yes

Bilateral Option (Swiss)

No

WTO rules, only-MFN with EU

Yes

Ukraine Option

No

Possible Scenarios for a UK entity

EU (QPPV) based in EEA

No extension to transition and no trade deal

Yes

No extension and a basic trade deal

Yes

A short extension

No

A longer extension and a trade deal

No

EEA member (Like Norway)

No

Customs Union (Turkey)

No

(Australia Type) worldwide fta- basis WTO

Yes

Bilateral Option (Swiss)

No

WTO rules, only-MFN with EU

Yes

Ukraine Option

Yes

Possible Scenarios for a UK entity

PSMF will legally have to reside in the Union (EEA)

No extension to transition and no trade deal

Yes

No extension and a basic trade deal

Yes

A short extension

No

A longer extension and a trade deal

No

EEA member (Like Norway)

No

Customs Union (Turkey)

No

(Australia Type) worldwide fta- basis WTO

Yes

Bilateral Option (Swiss)

No

WTO rules, only-MFN with EU

Yes

Ukraine Option

Yes

Possible Scenarios for a UK entity

Compliance to changes in GMP guidelines (if any)

No extension to transition and no trade deal

Yes

No extension and a basic trade deal

Yes

A short extension

No

A longer extension and a trade deal

Yes

EEA member (Like Norway)

Yes

Customs Union (Turkey)

Yes

(Australia Type) worldwide fta- basis WTO

Yes

Bilateral Option (Swiss)

No

WTO rules, only-MFN with EU

No

Ukraine Option

No

Possible Scenarios for a UK entity

Movement of goods affected Tariff/Non-Tariff barriers

No extension to transition and no trade deal

Both

No extension and a basic trade deal

Non-Tariff only

A short extension

No

A longer extension and a trade deal

Both

EEA member (Like Norway)

Non-Tariff only

Customs Union (Turkey)

No

(Australia Type) worldwide fta- basis WTO

Extreme tariff and moderate non-tariff

Bilateral Option (Swiss)

No

WTO rules, only-MFN with EU

High Non-Tariff barriers

Ukraine Option

High Non-tariff

Possible Scenarios for a UK entity

Movement of Resources Resource (RnD personnel, representative for Clinical Trial Authorisation) needs to move to EU/EEA

No extension to transition and no trade deal

No

No extension and a basic trade deal

No

A short extension

No

A longer extension and a trade deal

May not be necessary

EEA member (Like Norway)

Not Necessary

Customs Union (Turkey)

Yes

(Australia Type) worldwide fta- basis WTO

Yes

Bilateral Option (Swiss)

Yes

WTO rules, only-MFN with EU

No

Ukraine Option

Not possible

You want to know
the Impact on

  • Submit necessary variations e.g. Artwork/Labeling/Packaging
  • Representative Entity needed in EEA MRP/DCP National /Central Procedure
  • Can EU Citizens be recruited for trials
  • Sponsors Need Legal Representatives in the EU
  • Loss of Access to EU Clinical Trial Portal and Database
  • EU (QPPV) based in EEA
  • PSMF will legally have to reside in the Union (EEA)
  • Compliance to changes in GMP guidelines (if any)
  • Movement of goods affected Tariff/Non-Tariff barriers
  • Resource (RnD personnel, representative for Clinical Trial Authorisation) needs to move to UK

Possible Scenarios for an EU entity

Submit necessary
variations e.g.
Artwork/Labeling
/Packaging

No extension to transition and no trade deal

Yes

No extension and a basic trade deal

Yes

A short extension

No

A longer extension and a trade deal

Yes

EEA member (Like Norway)

Yes

Customs Union (Turkey)

Yes

(Australia Type) worldwide fta- basis WTO

Yes

Bilateral Option (Swiss)

Yes

WTO rules, only-MFN with EU

Yes

Ukraine Option

Yes

Possible Scenarios for an EU entity

"Representative
Entity needed
in UK MRP/
DCP National/
Central Procedure"

No extension to transition and no trade deal

Yes

No extension and a basic trade deal

Yes

A short extension

No

A longer extension and a trade deal

Yes

EEA member (Like Norway)

Yes

Customs Union (Turkey)

Yes

(Australia Type) worldwide fta- basis WTO

Yes

Bilateral Option (Swiss)

No

WTO rules, only-MFN with EU

No

Ukraine Option

No

Possible Scenarios for an EU entity

Can EU Citizens be recruited for trials

No extension to transition and no trade deal

No

No extension and a basic trade deal

No

A short extension

No

A longer extension and a trade deal

Yes

EEA member (Like Norway)

Yes

Customs Union (Turkey)

Yes

(Australia Type) worldwide fta- basis WTO

No

Bilateral Option (Swiss)

Yes

WTO rules, only-MFN with EU

No

Ukraine Option

Yes

Possible Scenarios for an EU entity

Sponsors Need Legal Representatives in the EU

No extension to transition and no trade deal

Yes

No extension and a basic trade deal

Yes

A short extension

No

A longer extension and a trade deal

No

EEA member (Like Norway)

No

Customs Union (Turkey)

No

(Australia Type) worldwide fta- basis WTO

Yes

Bilateral Option (Swiss)

No

WTO rules, only-MFN with EU

Yes

Ukraine Option

No

Possible Scenarios for an EU entity

Loss of Access to EU Clinical Trial Portal and Database

No extension to transition and no trade deal

Yes

No extension and a basic trade deal

Yes

A short extension

No

A longer extension and a trade deal

No

EEA member (Like Norway)

No

Customs Union (Turkey)

No

(Australia Type) worldwide fta- basis WTO

Yes

Bilateral Option (Swiss)

No

WTO rules, only-MFN with EU

Yes

Ukraine Option

No

Possible Scenarios for an EU entity

EU (QPPV) based in EEA

No extension to transition and no trade deal

Yes

No extension and a basic trade deal

Yes

A short extension

No

A longer extension and a trade deal

No

EEA member (Like Norway)

No

Customs Union (Turkey)

No

(Australia Type) worldwide fta- basis WTO

Yes

Bilateral Option (Swiss)

No

WTO rules, only-MFN with EU

Yes

Ukraine Option

Yes

Possible Scenarios for an EU entity

PSMF will legally have to reside in the Union (EEA)

No extension to transition and no trade deal

Yes

No extension and a basic trade deal

Yes

A short extension

No

A longer extension and a trade deal

No

EEA member (Like Norway)

No

Customs Union (Turkey)

No

(Australia Type) worldwide fta- basis WTO

Yes

Bilateral Option (Swiss)

No

WTO rules, only-MFN with EU

Yes

Ukraine Option

Yes

Possible Scenarios for an EU entity

Compliance to changes in GMP guidelines (if any)

No extension to transition and no trade deal

Yes

No extension and a basic trade deal

Yes

A short extension

No

A longer extension and a trade deal

Yes

EEA member (Like Norway)

Yes

Customs Union (Turkey)

Yes

(Australia Type) worldwide fta- basis WTO

Yes

Bilateral Option (Swiss)

No

WTO rules, only-MFN with EU

No

Ukraine Option

No

Possible Scenarios for an EU entity

Movement of goods affected Tariff/Non-Tariff barriers

No extension to transition and no trade deal

Both

No extension and a basic trade deal

Non-Tariff only

A short extension

No

A longer extension and a trade deal

Both

EEA member (Like Norway)

Non-Tariff only

Customs Union (Turkey)

No

(Australia Type) worldwide fta- basis WTO

Extreme tariff and moderate non-tariff

Bilateral Option (Swiss)

No

WTO rules, only-MFN with EU

High Non-Tariff barriers

Ukraine Option

High Non-tariff

Possible Scenarios for an EU entity

Resource (RnD personnel, representative for Clinical Trial Authorisation) needs to move to UK

No extension to transition and no trade deal

Yes

No extension and a basic trade deal

No

A short extension

No

A longer extension and a trade deal

No

EEA member (Like Norway)

No

Customs Union (Turkey)

Yes

(Australia Type) worldwide fta- basis WTO

Yes

Bilateral Option (Swiss)

Yes

WTO rules, only-MFN with EU

No

Ukraine Option

Not possible

You want to know
the Impact on

  • Submit necessary variations e.g. Artwork/Labeling/Packaging twice
  • Representative Entity needed in EEA MRP/DCP National /Central Procedure
  • Can EU Citizens be recruited for trials
  • Sponsors Need Legal Representatives in the EU
  • Loss of Access to EU Clinical Trial Portal and Database
  • UK/EU (QPPV) based in UK/EU respectively
  • PSMF will legally have to reside in the Union (EEA)
  • Compliance to changes in GMP guidelines (if any)
  • Movement of goods affected Tariff/Non-Tariff barriers

Possible Scenarios for an Intl Entity for further business in the EU and UK

Submit necessary
variations e.g.
Artwork/Labeling
/Packaging twice

No extension to transition and no trade deal

Yes

No extension and a basic trade deal

Yes

A short extension

No

A longer extension and a trade deal

Yes

EEA member (Like Norway)

Yes

Customs Union (Turkey)

Yes

(Australia Type) worldwide fta- basis WTO

Yes

Bilateral Option (Swiss)

Yes

WTO rules, only-MFN with EU

Yes

Ukraine Option

Yes

Possible Scenarios for an Intl Entity for further business in the EU and UK

"Representative Entity needed in EEA and UK separately
 MRP/DCP National/Central Procedure"

No extension to transition and no trade deal

Yes

No extension and a basic trade deal

Yes

A short extension

No

A longer extension and a trade deal

Yes

EEA member (Like Norway)

Yes

Customs Union (Turkey)

Yes

(Australia Type) worldwide fta- basis WTO

Yes

Bilateral Option (Swiss)

No

WTO rules, only-MFN with EU

No

Ukraine Option

Yes

Possible Scenarios for an Intl Entity for further business in the EU and UK

Can UK/EU Citizens be recruited for trials

No extension to transition and no trade deal

No

No extension and a basic trade deal

No

A short extension

No

A longer extension and a trade deal

Yes

EEA member (Like Norway)

Yes

Customs Union (Turkey)

Yes

(Australia Type) worldwide fta- basis WTO

No

Bilateral Option (Swiss)

Yes

WTO rules, only-MFN with EU

No

Ukraine Option

No

Possible Scenarios for an Intl Entity for further business in the EU and UK

Sponsors Need Legal Representatives in the UK/EU

No extension to transition and no trade deal

Yes

No extension and a basic trade deal

Yes

A short extension

No

A longer extension and a trade deal

No

EEA member (Like Norway)

No

Customs Union (Turkey)

No

(Australia Type) worldwide fta- basis WTO

Yes

Bilateral Option (Swiss)

No

WTO rules, only-MFN with EU

Yes

Ukraine Option

Yes

Possible Scenarios for an Intl Entity for further business in the EU and UK

Loss of Access to UK/EU Clinical Trial Portal and Database

No extension to transition and no trade deal

Yes

No extension and a basic trade deal

Yes

A short extension

No

A longer extension and a trade deal

No

EEA member (Like Norway)

No

Customs Union (Turkey)

No

(Australia Type) worldwide fta- basis WTO

Yes

Bilateral Option (Swiss)

No

WTO rules, only-MFN with EU

Yes

Ukraine Option

No

Possible Scenarios for an Intl Entity for further business in the EU and UK

UK/EU (QPPV) based in UK/EU respectively

No extension to transition and no trade deal

Yes

No extension and a basic trade deal

Yes

A short extension

No

A longer extension and a trade deal

No

EEA member (Like Norway)

Yes

Customs Union (Turkey)

Yes

(Australia Type) worldwide fta- basis WTO

Yes

Bilateral Option (Swiss)

Yes

WTO rules, only-MFN with EU

Yes

Ukraine Option

Yes

Possible Scenarios for an Intl Entity for further business in the EU and UK

PSMF will legally have to reside in the UK/Union (EEA)

No extension to transition and no trade deal

Yes

No extension and a basic trade deal

Yes

A short extension

No

A longer extension and a trade deal

No

EEA member (Like Norway)

Yes

Customs Union (Turkey)

Yes

(Australia Type) worldwide fta- basis WTO

Yes

Bilateral Option (Swiss)

Yes

WTO rules, only-MFN with EU

Yes

Ukraine Option

Yes

Possible Scenarios for an Intl Entity for further business in the EU and UK

Compliance to changes in GMP guidelines (if any)

No extension to transition and no trade deal

Yes

No extension and a basic trade deal

Yes

A short extension

No

A longer extension and a trade deal

Yes

EEA member (Like Norway)

Yes

Customs Union (Turkey)

Yes

(Australia Type) worldwide fta- basis WTO

Yes

Bilateral Option (Swiss)

No

WTO rules, only-MFN with EU

No

Ukraine Option

No

Possible Scenarios for an Intl Entity for further business in the EU and UK

Movement of goods affected Tariff/Non-Tariff barriers

No extension to transition and no trade deal

Both

No extension and a basic trade deal

Non-Tariff only

A short extension

No

A longer extension and a trade deal

Both

EEA member (Like Norway)

Non-Tariff only

Customs Union (Turkey)

No

(Australia Type) worldwide fta- basis WTO

Extreme tariff and moderate non-tariff

Bilateral Option (Swiss)

No

WTO rules, only-MFN with EU

High Non-Tariff barriers

Ukraine Option

High Non-tariff

Brexit is here. Are you going to get things done in time?

The need to Act fast

  • One thing is for sure, Pharma is going to bleed till regulations are not into place.
  • And after new regulations are into place, Market access is going to be the primary concern for every every company in the Lifesciences Industry
  • Market access needs to be expedited into multiple countries to ensure products hit shelves as soon as possible and reach the people who need them.

“The human world is rather regulated. Since the beginning of history, humans have always found ways to regulate each other's actions in order to maintain the structure of society, which has been built upon regulations that are passed down generation after generation. There is an old saying, 'a man with one watch knows what time it is; a man with two watches is never sure.' This might be true of the regulatory system around Brexit.

With its multiple layers and checks, there's too much ambiguity for anyone to know what is going on. With rising tensions between UK and the EU, It’s only speculative, what awaits Pharma.

At Freyr, Regulatory Intelligence team, is working around the clock to ensure all possible scenarios are mapped and all possible outcomes are predicted. By their side, our team of Regulatory experts is prepared to handle any regulatory challenges that come in the way of our clients’ products reaching the people (in the UK and the EU) who need them. We’re Prepared. And so are our clients.”

Freyr. Global, End-To-End, Regulatory Solutions and Services

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