Goods including medicines placed on the market in the EU or the UK before the end of the Brexit transition period (December 31) may continue to circulate between the two markets from January 1, the MHRA has said in an update on Wednesday (October 21).
According to the Article 41 of the EU Withdrawal Agreement, a medicine can be ‘placed on the market’ if it is available for sale or supply with a written or verbal agreement or offer of an agreement to transfer ownership of the medicine to another legal entity.
This includes medicines moving from Britain to Northern Ireland, the Medicines and Healthcare products Regulatory Agency (MHRA) noted.
Placing a manufacturing order for completion after 11pm on December 31 is insufficient to qualify for continued circulation, the agency said.
Instead, the medicine must have been manufactured, certified by a Qualified Person an made available for sale or supply in the manufacturer or wholesaler’s stock management system.
In addition, one of the following requirements must be met before 11pm on 31 Dec 2020:
- the medicine must have transferred ownership by sale or supply to another legal entity
- an offer to either purchase or take ownership of the medicine must have been made to the manufacturer or wholesaler by another legal entity (in this case the actual transfer of ownership may take place after 11pm on December 31)
This may include transfer of stock for sale or supply to different legal entities in the same company group.
“A medicine is placed on the market to move through the supply chain. Therefore, a medicine already in the supply chain before December 31, such as one stored by a wholesaler in the UK or the EU who has been sold or supplied the medicine (thus transferring ownership), can continue to be sold under Article 41 without further regulatory checks,” MHRA has added.
The wholesale dealer or manufacturer in Britain will be responsible for confirming that the person to be supplied in Northern Ireland is authorised to receive the product. They must ensure this prior to agreeing to supply the products to the region.
MHRA further said checks should be performed to confirm that a medicine has met the ’placed on the market’ criteria. To do this a manufacturer or wholesaler in Britain may either:
- confirm that each batch of medicine has met all of the relevant criteria for being placed on market
- confirm that ownership of the medicine has transferred between two UK or EU legal entities before 11pm on 31 December 2020.
Acceptable evidence of this confirmation will include a written statement from the manufacturer or a wholesaler who has sold or supplied the batch or reference to company internal systems that shows that the batch has been released for sale and transfer of ownership has occurred.
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.