Guidance on supplying medicines to Northern Ireland post-transition

What do you need to do to supply authorised medicines from Great Britain (GB) to Northern Ireland (NI)?

Medicines that have been certified by a Qualified Person (QP) and released for sale / supply before 11pm on 31 December 2020 can remain available for distribution between GB, NI and the EU after 1 January 2021 without additional regulatory checks.

They may be supplied to a wholesale dealer or other authorised person, such as a pharmacy or hospital in NI, by a manufacturer or wholesaler in GB.

The wholesale dealer or manufacturer in GB will be responsible for confirming that the person to be supplied in NI is authorised to receive the product. This must be prior to agreeing to supply the products and will be dependent on when the product was placed on the market.

Prior to sale / supply, a batch of medicines may be confirmed as being placed on the market before 11pm on 31 December 2020 using evidence such as:

  • A written statement from the manufacturer or a wholesaler who has sold or supplied the batch.
  • Reference to company internal systems (e.g. global Enterprise Resource Planning system) that shows batch certification.

To enable this supply chain verification, manufacturers are encouraged to ensure that the date of placing on the market is visible to the supply chain.

For more information click here.