Brexit ‘No Deal’ – What does it mean?

With less than 70 days to the 31st October Brexit deadline and the heightened risk of a ‘no deal’. Governments and companies are finalizing ‘no deal’ plans.

What will the impact be for the Biopharmaceutical Industries?
The UK will be treated as a 3rd Country.

What does this mean?
1. All products manufactured in the UK must be QP released in the EU for the EU.
2. All products manufactured in the UK must be tested in the EU for the EU.

3. There are also associated risks to RoW Markets.
4. There is a risk of delays at borders in and out of the UK. How long these delays will be is unknown.

Are products only manufactured in the UK impacted?
NO, any product that has a UK ‘touchpoint’ is impacted.

What are Biopharmaceutical companies doing?
1. Reviewing and updating supply chains
2. Transferring release and testing out of the UK to the EU
3. Transferring distribution centers out of the UK to the EU
4. Stockpiling medicines where feasible

Are you ready ?
If you need any guidance or support in your final stages of planning e.g
1. Supply Chain review
2. Due Diligence Assessments
3. Warehousing/Distribution
4. Contract Resources – Project Management, Supply Chain, Quality

Please reach out to us TODAY www.independentsolutions.ie / info@indepedentsolutions.ie

Relevant links

http://www.hpra.ie/homepage/about-us/stakeholders/brexit/brexit—latest-information

https://www.ema.europa.eu/en/about-us/united-kingdoms-withdrawal-european-union-brexit

https://www.bbc.com/news/amp/uk-politics-46393399

Are you ready for the Unique Device Identification (UDI) System requirement under the EU Medical Device Regulations 2017/745 and 2017/746 regulation – Effective May 2020?

Are you ready for the Unique Device Identification (UDI) System requirement under the EU Medical Device Regulations 2017/745 and 2017/746 regulation – Effective May 2020?

Are you ready for the Unique Device Identification (UDI) System requirement under the EU Medical Device Regulations 2017/745 and 2017/746 regulation – Effective May 2020?

The European Medical Device Regulations for Unique Device Identification (UDI) will be effective May 2020, this mandates that any company supplying Medical Devices in the European Union are legally obliged to comply. Are you compliant?

May 2020, a Unique Device Identification (UDI) must be assigned by the manufacturer to every medical device, and every time there is a change in the product the manufacturer must evaluate the UDI. Are you ready for May 2020?