Version update: 4 August 2023
The United Kingdom (UK) left the European Union (EU) on 31 January 2020 and moved into a transition period which ended on 31 December 2020 with the UK and EU agreeing to a Trade and Cooperation Agreement on 24 December 2020.
During the transition period the UK continued to follow EU legislation and regulations, but this changed on 1 January 2021. From 1 January 2021 Northern Ireland (NI) has continued to be aligned to EU legislation and regulations in respect of medicines and medical devices as a requisite of the Ireland/NI Protocol and Great Britain (GB) has not.
The Medicines and Healthcare products Regulatory Agency (MHRA) has provided comprehensive UK wide guidance on a range of topics for the pharmaceutical industry relating to the end of the transition period. Guidance on the supply of medicines into NI is also included. The guidance on the UK Government website covers a range of technical areas, such as licensing, pharmacovigilance and importing and exporting medicines.
On 17 December 2021, the European Commission (EC) announced proposals on medicine supply issues in the context of the implementation of the Northern Ireland (NI) Protocol and published a written statement EU-UK relations: Commission proposes solution (europa.eu). The EC’s proposals were adopted into legislation following their publication in the Official Journal of the EU on 20 April 2022. Further information can be found at the Publications Office of the EU.
On 27 February, the Windsor Framework was announced. The EU has since adopted the associated legislation relating to medicinal products for human use to be placed on the market in NI. The UK Government has outlined timelines associated with the implementation of the Windsor Framework for medicines.
What has the Department of Health (DoH) done to ensure the continuance of medical supplies into NI?
The Department of Health and Social Care (DHSC) leads on the arrangements for maintaining healthcare supply chains on behalf of the devolved administrations. Officials from the Department of Health have been and will continue to work closely with the DHSC, the MHRA, other NI Civil Service Departments and UK Government Departments to mitigate any risks to the supply chain.
Medicine and medical devices are manufactured as part of a global and highly complex industry therefore shortages of medicines and other medical supplies are not uncommon for reasons unconnected to EU exit and the implementation of the NI Protocol.
There are already national and locally tried and tested contingency arrangements in place for dealing with any supply disruptions to ensure that patients continue to get the medical supplies they need. These include (but are not limited to) communicating with primary and secondary healthcare professionals and detailing any potential shortages or issues with the supply chain and the best alternative products.
No one can provide an absolute guarantee that there will not be any disruption to medical supplies in the future, however we can assure the public that we work with all stakeholders to mitigate against such disruptions.
What is the Northern Ireland MHRA Authorised Route (NIMAR)?
The MHRA and the DHSC worked closely with DoH officials to create a contingency measure to further support the supply of medicines to NI. This measure has been operational since 1 January 2022.
On 16 December 2021 the UK Government introduced a statutory instrument entitled the Human Medicines (Amendment) (Supply to Northern Ireland) Regulations 2021. These regulations were brought forward to establish the Northern Ireland MHRA Authorised Route (NIMAR), which helps to ensure that people in NI can continue to access the medicines they need.
This regulatory approach is based on an existing EU directive. It ensures patients in NI can access prescription only medicines at the same time as patients in GB. All medicinal products using NIMAR will have met the MHRA’s stringent requirements for safety, quality and efficacy.
Doctors, pharmacists, and patients in NI do not need to do anything differently to prescribe or access medicines through this route. It is a legal measure to help support supply chains into NI where required.
Medicines on the NIMAR list will all be licensed by the MHRA in GB and authorised for supply to NI on an unlicensed basis, where no licensed alternative is available.
Further information about NIMAR can be accessed on the UK government website.
The NIMAR list can be accessed on the UK government website.
I am a community pharmacist in NI. Can I dispense a prescription issued by a health professional from the EU?
Some changes to the Human Medicines Regulations (HMR) 2012 were made by the Human Medicines (Amendment etc.) (EU Exit) Regulations 2019. Following the end of transition, a prescription issued by ‘an approved country health profession’ can be dispensed in NI provided all other legal requirements are met as laid out under HMR 2012. The current list of approved countries and health professional will be reviewed at least every 3 years and can be found on the UK Government website.
Any changes to this list will be communicated to pharmacists in good time to enable them to amend their practices appropriately.
Legislation relating to controlled drugs has not changed. Pharmacists cannot dispense a controlled drug listed in Schedule 1, 2 or 3 of the Misuse of Drugs Regulations (NI) 2002 against a prescription issued by an approved country health professional.
Similarly, pharmacists cannot dispense medicines that do not have a valid Marketing Authorisation against a prescription issued by an approved country health professional.
When deciding to dispense a prescription issued by an approved country health professional a pharmacist should always continue to exercise their professional judgement.
Please see a published letter sent to registered pharmacies by Canice Ward, Head of Medicines Regulatory Group clarifying the process for dispensing prescriptions issued by EEA health professionals following the transition period.
How are medicines licensed in NI?
There are a number of options available for companies who wish to gain a licence (marketing authorisation) for a medicine for use in NI.
- Marketing Authorisations (MA) approved under the EU Centralised Authorisation Procedure (CAP) will automatically have effect in NI.
- NI may also be included in decentralised or mutual recognition procedures as a concerned member state.
- The MHRA can also approve a medicine that falls outside of the scope of the EU centralised procedure for use in NI or the whole of the UK.
Updated advice and guidance from the MHRA on the licensing of medicines throughout the UK can be found on the UK Government website.
The CAP bridging mechanism is part of the EU legislative package for medicines passed in April 2022. This permits the supply of a newly approved MA by the MHRA onto the NI market for up to six months, or until the EU make a decision on a parallel CAP application. Advice and guidance on the CAP bridging mechanism can be found via the UK Government website.
Is there a need for additional controlled drug licences for trade between GB, NI, and the EU market?
There is no need for additional licensing beyond the requirements that existed prior to the end of EU exit transition for controlled drugs for trade between GB and NI.
Similarly access to the EU market from the UK, including from NI, has not changed following the end of transition. Traders should continue to undertake the necessary requirements that they previously carried out when trading controlled drugs from NI to the EU and vice versa.
I am a medicines wholesaler and I export/ import medicines that contain controlled drugs between NI and GB. Are there any additional licences or requirements for moving these goods?
There will be no new licensing requirements under Misuse of Drugs legislation for companies moving controlled drug medicines from GB to NI because of the NI Protocol.
However, medicines containing controlled drugs will be subject to EU regulations when placed on the NI market from GB. The UK Government and EU Commission have agreed a grace period to allow industry time to comply with these regulations at the end of the transition period.
It is also important to note that controlled drugs are not considered controlled goods in terms of movement between GB and NI.
Trading in drug precursor chemicals between Great Britain and Northern Ireland
The UK left the EU on 31 January 2020 and the transition period existed to allow businesses to prepare for any regulatory changes. This transition period ended on 31 December 2020.
The NI Protocol affects the future trading relationship between GB and NI for drug precursor chemical control.
For the purposes of drug precursor chemical control, NI will continue to apply EU regulations, whilst GB will not. This means that NI companies trading with EU Member States will not require import or export licences as this is considered ‘intra-community trade’.
However, trade between GB and NI will be subject to licensing in accordance with the requirements in Precursor chemical export and import authorisation. This includes ‘category 4’ drug precursor chemicals, namely Medicinal Preparations of ephedrine and pseudoephedrine.
The Home Office Drugs and Firearms Licensing Unit continues to act as the UK Competent Authority for drug precursor chemical control. Both GB and NI companies should apply to the Drugs and Firearms Licensing Unit for their licences.
Call: 0300 105 0248
Falsified Medicines Directive
What about the Falsified Medicines Directive (FMD)? Do end users still need to decommission medicines in NI?
Yes. NI has continued to remain aligned with EU legislation and regulation. Therefore, end users in NI including community pharmacies must continue to comply with FMD and will be required to continue to verify and decommission unique identifiers on medicines packs at the point of supply.
NI has remained connected to the National Medicines Verification System (NMVS) facilitated by SecurMed UK. SecurMed UK have continued to provide end user registration and necessary support to enable the decommissioning of packs with FMD identifier features following the end of transition. More information can be found via SecurMed and the UK Government website.
How are medical devices impacted?
Further information on the regulation of medical devices in NI can be found on the UK Government website. The EU has extended the transition periods for medical device certification and validity of existing CE certificates. More information can be found on the UK Government website.