How the supply of medicines into Northern Ireland works.
10 September 2021 update
In its July Command Paper, the Government set out proposals for a new balance in how the Protocol is operated.
In order to provide certainty and stability as discussions proceed between the UK and EU on these proposals, the Government has set out that it will continue to operate the Protocol on its current basis. This will mean that existing arrangements continue in force, including extending the specific arrangements/easements/grace period.
The Government will ensure that reasonable notice is provided in the event that any of these arrangements are to change, to enable businesses and citizens to make appropriate preparations.
Further information will be provided soon.
A key part of the agreement on the UK withdrawal from the European Union is the implementation of the Northern Ireland Protocol. The effect of the Northern Ireland Protocol is that medicines on the Northern Ireland market, including over the counter (OTC) medicines, are required to comply with EU regulations and directives as well as with UK law.
Under the Northern Ireland Protocol, any authorised medicine moving from or through Great Britain (England, Wales and Scotland) to Northern Ireland is considered an import into the EU. A medicine retailer or wholesaler is consequently considered an importer for Northern Ireland.
This has implications for the supply of all consumer healthcare products to Northern Ireland, especially impacting medicines that have specific regulatory requirements that need to be fulfilled.
What you need to do to supply authorised medicines from Great Britain to Northern Ireland
The UK and the EU have agreed a phased process for implementing medicines regulation in Northern Ireland up to 31 December 2021, providing for a pragmatic approach to applying EU rules on batch testing, regulatory importation, and Falsified Medicines Directive requirements will be in place for 12 months after the end of the Brexit transition period to ensure supply.
However, this is a temporary solution, during which companies will need to prepare for changes to Northern Ireland Supply routes.
From 1 January 2022 Northern Ireland will remain de facto in the EU single market and additional regulatory importation controls will be required, to be carried out in Northern Ireland or an EEA member state.
Supply of authorised medicines until 31 December 2021
Medicines can be supplied from Great Britain to Northern Ireland without requiring additional regulatory importation controls (manufacture and import authorisation, batch testing and qualified person (QP) certification done in Northern Ireland or an EEA state) until 31 December 2021.
This means medicinal products can continue to be supplied from Great Britain to Northern Ireland without additional regulatory importation requirements.
The serialisation requirements of EU Delegated Regulation 2016/161 remain in Northern Ireland. The majority of prescription-only-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 Northern Ireland (including UK wide MAs) supplied by a manufacturer or wholesaler in the EEA will not require decommissioning when exported from the EU to the UK until the 31 December 2021. Unique identifiers on these packs should be decommissioned in Northern Ireland as required by EU Delegated Regulation 2016/161.
Medicines released post-transition with a marketing authorisation valid only in Great Britain will not require a Unique Identifier. However, we encourage companies to retain the tamper evident device. Unique Identifiers may be placed voluntarily on Great Britain packs; however, these do not require upload to the medicines verification system.
Industry must notify the MHRA if they will not be using certain flexibilities. See our detailed guidance on importing medicines into Northern Ireland before 31 December 2021.
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 to be undertaken in Northern Ireland or an EEA Member State, on a per shipment basis:
- 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 as part of the importation steps prior to placing the product on the Northern Ireland market.
Alternative supply chain options
It is important that supply chains prepare for changes to Northern Ireland supply routes before 1 January 2022. There are alternative supply chain options that will not require importation controls to be performed in Northern Ireland or an EEA Member 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 Qualified Person certification activities
See MHRA guidance: Supplying authorised medicines to Northern Ireland
Medicines placed on the market before the end of the transition period
Medicines that were placed on the market in the European Union or the United Kingdom before the end of the transition period (31 December 2020) may continue to circulate between these two markets. This includes medicines moving from Great Britain to Northern Ireland.
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 qualified person certified.
This is stated in Article 41 of the EU Withdrawal Agreement.
Glossary of terms
Importer / manufacturer
Medicines may be manufactured in the EEA / Northern Ireland under a manufacturer authorisation. The manufacturer or importer of a medicine must hold an authorisation granted by the medicine’s regulator.
The authorisation holder must demonstrate that they have the correct facilities, equipment, procedures and personnel to handle or manufacture medicines. The authorisation must also name a ‘Qualified Person’ who is legally responsible for certifying the quality of batches before they are released for sale.
If medicines are manufactured in a ‘third country’ (anywhere outside the EEA / Northern Ireland, including Great Britain) they must be imported into the EEA / Northern Ireland by an authorised importer who is responsible for performing quality checks before releasing the product to the market.
Laboratory analysis of the medicine to confirm that it complies with its specification (for example, the quantity of active substance (e.g. paracetamol) per tablet).
Batch testing must be done by a laboratory in the EEA / Northern Ireland, unless the product was manufactured in a mutual recognition country where the results are accepted by the EU.
Qualified Person certification
EU law requires that medicines are quality checked and certified by a highly qualified person that is named on the importation licence.
This person is responsible for confirming that the product has been manufactured correctly, complies with the regulatory approval, and that the results of the batch testing are acceptable.
The Qualified Person must be named on the EEA / Northern Ireland manufacturer or import authorisation.
For further information, please email our Customer Services Centre at email@example.com or call 020 3080 6000.