Although the Brexit Transition period ends on December 31 2020 at 11 pm in the UK, the Medicines and Healthcare products Regulatory Agency (MHRA) believes the exchange and circulation of medical goods may continue till January 1 2021 (as per their update on October 21 2020).
Article 41 (1) of the EU Withdrawal Agreement states “that an existing and individually identifiable good lawfully placed on the market in the EU or the United Kingdom before the end of the transition period may be further made available on the market of the EU or of the United Kingdom and circulate between these two markets until it reaches its end user.” So, any medicine can be made available in the market for purchase or supply through an agreement (written or verbal – even through transfer of ownership) to another legal entity.
The MHRA agency has stressed that any orders for manufacturing completion placed after the deadline of December 11 2020 post 11 pm will not qualify for continued circulation. The medicine should be made available in the stock management systems of manufacturers and wholesalers for sale or supply by being certified by a Qualified Person after it’s been manufactured.
Other points to note before the deadline comes into effect are:
- The transferred ownership of medicines should be by sale or supply to another legal entity
- Purchase or ownership of medicines must be made by another legal entity to the manufacturer or wholesaler.
- The transfer of ownership may take place after 11pm on December in the above mentioned situation
- Transfer of sale or supply to different legal entities may also be applicable to different legal entities in the same organization group
The MHRA has also mentioned under Article 41 that medicine already in the supply chain prior to the deadline may still be sold without further regulatory checks.
It is however the responsibility of the wholesale dealer or manufacturer in the UK to confirm the individual in Northern Ireland is authorised to receive the supplied product. They also need to make sure that this agreement is accepted beforehand and prior to the products being supplied to the region. Please note, for supply chain verification, it is suggested that manufacturers ensure the date of when the product was placed in the market is visible to the entire supply chain.
Manufacturers and wholesalers in the UK will need to perform checks on medicines that have been made available in the market. They will need to either confirm that each of the medicine batches has met all the requirements and criteria before being placed in the market or confirm that the ownership of the specific medicine has been transferred between EU or UK legal entities before the deadline in December. It is also important to include evidence of confirmation and one way to do so is via a written statement from the manufacturer or wholesaler to companies. The statement must mention the batch information that has been made available for sale and it should also include the transfer of ownership.
Sources:
- EU WITHDRAWAL OF THE UNITED KINGDOM AND EU RULES IN THE FIELD OF PYROTECHNIC ARTICLES, 6 July 2020
- https://www.gov.uk/guidance/supplying-medicines-to-northern-ireland-from-1-january-2021