Taking a pragmatic approach to Brexit

On 01 September 2020 the MHRA published new guidelines on the impact of Brexit to the Pharmaceutical and medical devices industry.  There are some very specific considerations for Northern Ireland that have provided some welcome and much needed clarity to the industry.  Our team which includes SMEs from the UK and the EU are ready to assist you with implementing the new guidance.  If you would like our Brexit expert team to examine your Strategy and work with you to prepare for the future, please connect with us to discuss brexitsupport@pharmalex.com.

The key points are:

• MDR / IVDR and CE Marking:  The UK will not be implementing the MDR / IVDR and will instead pursue its own path-to-market in place of the CE mark known as the UK Conformity Assessed (UKCA) marking.   However a CE mark will continue to be needed for devices placed on the Northern Ireland market (and EU/EEA) and EU rules will need to be met.  In practice therefore for operations in Northern Ireland, MDR / IVDR implementation will need to proceed and it is likely that manufacturers supplying GB, NI and EU markets will need to utilise both the CE and UKCA marks.

 

• Medical Device Authorised Representatives:  Manufacturers based outside the EU with a Great Britain-based Authorised Representative should engage an Authorised Representative based in the EU or Northern Ireland.   Manufacturers in Great Britain who wish to continue to supply CE marked devices to the EU market should establish an Authorised Representative in the EU or Northern Ireland, to register and act on their behalf.

 

• Centrally Authorised Market Authorisations:  These will automatically be converted into UK MAs effective in Great Britain (excluding Northern Ireland) and issued with a UK MA number on 01 January 2021.  Currently pending and future applications for Community Marketing Authorisations will continue to include Northern Ireland, and when granted the authorisation will cover marketing of the product in Northern Ireland.

 

• Packaging requirements:  Once a GB MA is issued then the MAH will have 24 months from the end of transition period to submit appropriate amended artwork and then a further 12 months (36 months total) to transition to releasing stock in compliant packaging.  The MHRA will continue to allow multi-country packs provided that the entirety of the information is compliant with the UK requirements, in practical terms therefore it is likely that UK wide distribution will require multi-country packs with both the PLGB and CAP licence numbers.

 

• Conditional Marketing Authorisation:  The MHRA will introduce a national Conditional Marketing Authorisation (CMA) scheme for new medicinal products for unmet medical needs in Great Britain from 1 January 2021.   The EU, EEA and Northern Ireland will continue to submit to the EMA under the centrally Authorised Procedure as before.

 

• Parallel Distribution Notices/Parallel Import Licences: Parallel Distribution Notices (PDNs) will no longer be valid in Great Britain (Excluding NI) and will be replaced by Parallel Import Licences (PIL) which will allow the products to be marketed in Great Britain only.

 

• Active Substances: Written confirmation will be required from 01 January 2021 for each shipment of Active Substances manufactured in Great Britain that is exported to the EEA or Northern Ireland.

 

• Import / Export under a WDA:  Medicinal products sourced from Northern Ireland to Great Britain for wholesale purposes are permitted under the supervision of a Responsible Person (RP) and will not require an RPi.

 

• Specials / Unlicensed Medication:  A WDA is required If you source a medicine without an authorisation in UK or Great Britain from Northern Ireland for supply to the Great Britain market.

 

We will follow up with additional details/clarifications as more information becomes available, in the meantime, please feel free to contact us at brexitsupport@pharmalex.com  for additional information.