Supplying Medicines NI UK Post-Deal Guidance

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MedicinesNI Goods StandardsUK Post-Deal Published Guidance
Guidance

Supplying authorised medicines to Northern Ireland

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

Published 31 December 2020
From:
Medicines and Healthcare products Regulatory Agency

1. Supply of authorised medicines until 31 December 2021

Medicines can be supplied from Great Britain (GB) to Northern Ireland (NI) with a pragmatic approach to applying EU rules on importation and unique identifier requirements until 31 December 2021. Apart from these two areas, medicines for the Northern Ireland market must follow the EU acquis as per the Northern Ireland Protocol. This is as set out in the draft EU Unilateral Declaration in the Withdrawal Agreement Joint Committee.

Batch testing and QP certification will continue to be required to place a product on the UK market as per the requirements detailed in regulation 41(2) of the Human Medicines Regulations 2012. Batch testing and QP certification done in Great Britain (England, Wales and Scotland) will enable supply to Northern Ireland until 31 December 2021. Batch testing and QP certification done in the EU/EEA will also enable supply to Northern Ireland via Great Britain (including packs not moved under transit procedures using the Common Transit Convention) until 31 December 2021.

Medicines can be supplied from the Great Britain market to Northern Ireland without requiring additional regulatory importation controls (manufacture and import authorisation, batch testing and QP certification done in Northern Ireland or an EEA state) until 31 December 2021. This means that wholesale dealers can continue to supply medicines from GB to NI for an additional 12 months beyond the end of the transition period.

The serialisation requirements of EU Delegated Regulation 2016/161 will continue in Northern Ireland from 1 January 2021. Medicines with a marketing authorisation valid in Northern Ireland will require a unique identifier and a tamper evident device on each pack.

The unique identifiers on packs with a marketing authorisation valid in NI (including UK-wide MAs) supplied by a manufacturer or wholesaler in the EEA will not require decommissioning when exported to the UK until the 31st December 2021. Unique identifiers on these packs should be decommissioned in Northern Ireland as required by EU Delegated Regulation 2016/161.

Medicines with a marketing authorisation valid only in Great Britain (England, Wales and Scotland) will not require a Unique Identifier. However, we encourage companies to retain the tamper evidence device. Unique Identifiers may be placed voluntarily on GB packs; however, these do not require upload as there is no obligation and will be no capability to decommission in GB.

2. Supply of authorised medicines from 1 January 2022

From 1 January 2022, medicines supplied from the Great Britain market to Northern Ireland will require the following importation controls done in Northern Ireland or an EEA state:

  • Importation via a Manufacture and Importation Authorisation (MIA) holder
  • Batch testing
  • Certification by a Qualified Person

The unique identifiers on UK packs exported to Great Britain by a manufacturer or wholesaler in the EEA will require decommissioning. If these packs are later supplied to Northern Ireland, new unique identifiers should be applied to packs and uploaded to the EU medicines verification hub, unless they were placed on the market before 11pm on 31 December 2020 (see section 4 below). It is important to note that the additional flexibilities for importation and serialisation requirements until 31 December 2021 do not impact on the timing of Article 41 which will only apply for medicines placed on the market before 11pm on 31 December 2020.

It is important that supply chains prepare for changes to Northern Ireland supply routes before 1 January 2022. There are other supply chain options that will not require importation controls to be performed in Northern Ireland or an EEA state. These include:

  • use of the Common Transit Convention when transporting goods via Great Britain
  • routing Northern Ireland logistics directly from the EEA
  • changing the location of batch testing and QP certification activities

3. Supply of medicines that are on the market before 11pm on 31 December 2020

The flexibilities for importation and serialisation requirements until 31 December 2021 do not impact on the timing of Article 41 which will only apply for medicines placed on the market before 11pm 31 December 2020.

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.

4. 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 11:00pm on 31 December 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 December 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 11:00pm on 31 December 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.

5. 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.

6. 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 11:00pm 31 December 2020.
  • the sale or transfer of ownership is not complete before 11:00pm 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.

7. Licensing requirements for medicines containing controlled drugs from 1 January 2021

There will be no changes to licensing requirements for medicines containing controlled drugs after the end of the transition period. This is covered by UK legislation.

Controlled drugs are controlled in the UK under the Misuse of Drugs Act 1971 (‘the 1971 Act’) and the Misuse of Drugs Regulations 2001 (‘the 2001 Regulations’).

From 1 January 2021 Home Office controlled drug import-export licensing requirements for trade in controlled drugs within the UK will not change.

Home Office controlled drug import-export licensing requirements for trade in controlled drugs from the UK, including from Northern Ireland, to the EU, and vice versa, will not change.

See the list of the controlled drugs most enquired about. The list is not exhaustive and, in the event of a substance not being listed, reference should also be made to the 1971 Act and the 2001 Regulations at legislation.gov.uk.

There will be no new licensing requirements under the 1971 Act for companies moving medicines containing controlled drugs from Great Britain to Northern Ireland as a result of the Protocol.

See guidance on how to apply for a Home Office controlled drug import-export licence for trade in controlled drugs from the UK.

8. 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 31 December 2020
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