Importing Medicines to NI 2021 UK Guidance

by
MedicinesUK Post-Exit Guidance Notes [2020]
Guidance

Supplying medicines to Northern Ireland from 1 January 2021

What you need to do to supply authorised medicines from Great Britain to Northern Ireland.

Published 1 October 2020
Last updated 20 October 2020 — see all updates
From:
Medicines and Healthcare products Regulatory Agency

New rules for January 2021

The UK has left the EU, and the transition period after Brexit comes to an end this year.

This page tells you what you’ll need to do from 1 January 2021. It will be updated if anything changes.

Check what else you need to do during the transition period.

This guidance currently covers Article 41. We will update this guidance to cover all aspects of supplying medicines to Northern Ireland from 1 January 2021 in due course.

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 includes medicines moving from Great Britain to Northern Ireland.

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 and there has been a written or verbal agreement (or offer of an agreement) to transfer ownership of the medicine to another legal entity.

Placing a manufacturing order for completion after 11pm on 31 December 2020 is insufficient to qualify for continued circulation. The medicine must have been manufactured and QP certified.

Medicines placed on the market before 11pm on 31 December 2020

Batches of medicines qualify for continued circulation including from Great Britain to Northern Ireland under Article 41 if, before 11pm on 31 Dec 2020, they meet all of the following requirements:

  • manufactured
  • certified by a Qualified Person
  • made available for sale or supply in the manufacturer or wholesaler’s stock management system,

In addition to meeting the above criteria, before 11pm on 31 Dec 2020, one of the following requirements must be met:

  • 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 31 Dec 2020)

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 11pm on 31 December 2020, 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.

Checks required prior to sale or supply into Northern Ireland 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. The wholesaler or manufacturer must undertake this prior to agreeing to supply the products to Northern Ireland. Medicines placed on the market before 11pm on 31 December 2020 may be supplied to a wholesaler or other authorised person in Northern Ireland.

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 Great Britain may either:

  • confirm that each batch of medicine has met all of the relevant criteria for being placed on market as listed above
  • confirm that ownership of the medicine has transferred between 2 UK or EU legal entities before 11pm on 31 December 2020. This alone would suffice, as a medicine cannot legally be sold or supplied unless all the steps above have been met.

Acceptable evidence of this confirmation include:

  • a written statement from the manufacturer or a wholesaler who has sold or supplied the batch,
  • reference to company internal systems (such as global Enterprise Resource Planning system) that shows that the batch has been released for sale and transfer of ownership has occurred.

Other forms of evidence are acceptable.

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.

Case Studies

Case Study 1

  • a medicine has been QP certified and is in the manufacturer or wholesaler’s warehouse before the end of the transition period.
  • the batch is ‘on hold’ in the warehouse inventory system for stock management reasons.

This medicine has not been placed on the market as it is not available for sale or supply. If the batch were marked in the warehouse system as available to supply customers when orders are received this would qualify for the purposes of provisions under Article 41 but only once an agreement (or offer of such an agreement) to transfer ownership for sale or supply of the medicine from the manufacturer or wholesaler to another legal entity has taken place.

Case Study 2

  • a medicine has been QP certified, is in the manufacturer or wholesaler’s warehouse in an EU state before the end of the transition period. It is marked as available for sale or supply in the warehouse system.
  • the ownership of that medicine then is transferred over to the UK affiliate which is a separate legal entity from the original owner.
  • the medicine is still physically located in the EU warehouse.

This medicine has been placed on the market and would qualify for provisions under Article 41. It could be supplied to Northern Ireland after the end of the transition period.

Case Study 3

  • a medicine has been QP certified and is in the manufacturer or wholesaler’s warehouse in an EU state before the end of the transition period. It is marked as available for sale or supply in the warehouse system.
  • a separate legal entity to the manufacturer or wholesaler offers to either purchase or take ownership of the medicine before 11pm 31 December 2020.
  • the sale or transfer of ownership is not complete before 11pm 31 December 2020.

This medicine has been placed on the market and would qualify for provisions under Article 41. It could be supplied to Northern Ireland after the end of the transition period.

Case Study 4

  • a medicine has been QP certified and is in the manufacturer or wholesaler’s warehouse in the UK before the end of the transition period. It is marked as available for sale or supply in the warehouse system.
  • ownership of the medicine has not transferred to another legal entity before the end of the transition period.
  • no offer has been made by another legal entity to the manufacturer or wholesaler to take ownership of the medicine before the end of the transition period.

This medicine has not been placed on the market and does not qualify for the provisions under Article 41 as ownership has not transferred to another legal entity or an offer has not been made to the manufacturer or wholesaler by another legal entity.

Case Study 5

  • a medicine has been QP certified, is in the manufacturer or wholesaler’s warehouse in the UK before the end of the transition period. It is marked as available for sale or supply in the warehouse system.
  • ownership of the medicine is transferred to a different legal entity, for example, a company affiliate in the EU. This takes place before the end of the transition period.
  • ownership is then transferred back to the wholesaler or manufacturer. This second transfer of ownership could either take place before or after the end of the transition period.
  • the medicine remains in the same physical location.

This medicine has been placed on the market and qualifies for the provisions under Article 41 as ownership has transferred to another legal entity before the end of the transition period and it is available for sale or supply.

Case Study 6

  • a medicine has been QP certified, is in the manufacturer or wholesaler’s warehouse in the UK before the end of the transition period.
  • ownership of the medicine is transferred to a different legal entity, for example, a company affiliate in the EU.
  • the batch is pre-allocated to supply a specific market (such as Northern Ireland)

This medicine has been placed on the market and qualifies for the provisions under Article 41 as ownership has transferred to another legal entity and it is available for sale or supply.

Contact

For further information, please email our Customer Services Centre at info@mhra.gov.uk or call 020 3080 6000. Alternatively, contact your Trade Association by emailing:

Published 1 October 2020
Last updated 20 October 2020 
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