Home Banner
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
-
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.
Your business operations are
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 |
|
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 |
|
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 |
|
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 |
|
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 |
|
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 |
|
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
USA
UK
GERMANY
INDIA