The MHRA has published new guidance on “Supplying medicines to Northern Ireland from January 2021” to help wholesale dealers or manufacturers in Great Britain sell or supply authorised medicines to authorised persons in Northern Ireland following the end of the transition period.
The new guidance covers the following matters:
- Medicines placed on the market in the EU or UK before 11:00 p.m. on December 31, 2020: Article 41 of the EU Withdrawal Agreement enables these batches to remain available for sale or supply between GB, Northern Ireland and the EU after January 1, 2021 without additional regulatory checks; a medicine has been “placed on the market” if it has been certified by a Qualified Person and released for sale or supply.
- Checks required prior to sale or supply to confirm medicines were placed on the market before 11:00 p.m. on December 31, 2020: Prior to agreeing to supply the products, the wholesale dealer or manufacturer in GB will be responsible for confirming that the person to be supplied in Northern Ireland is authorised to receive the product; manufacturers are encouraged to ensure that the date of placing on the market is visible to the supply chain.
- Examples of evidence to confirm that a batch has been placed on the market before 11:00 p.m. on December 31, 2020: A written statement from the manufacturer or a wholesaler who has sold or supplied the batch or a reference to company internal systems that shows batch certification e.g. global Enterprise Resource Planning system.
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