Medicines Healthcare Products Regulatory Agency
Goods placed on the market in the European Union or the United Kingdom before the end of the transition period may continue to circulate between these two markets from 1 January 2021.
This is stated in Article 41 of the EU Withdrawal Agreement.
A medicine is placed on the market if it is available for sale or supply.
Medicines placed on the market before 11pm on 31 December 2020
Medicines that have been certified by a Qualified Person and released for sale or supply before 11pm on 31 December 2020 have been placed on the market.
Article 41 enables these batches to remain available for sale or supply between Great Britain, Northern Ireland 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 Northern Ireland by a manufacturer or wholesaler in Great Britain.
Checks required prior to sale or supply to confirm medicines were placed on the market before 11pm on 31 December 2020
The wholesale dealer or manufacturer in Great Britain will be responsible for confirming that the person to be supplied in Northern Ireland is authorised to receive the product. This must be prior to agreeing to supply the products. It will be dependent on when the product was placed on the market.
A batch 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 guidance on supplying unauthorised medicines (Specials), read Import a human medicine.
MHRA may update this guidance in due course.