Brexit

In line with the whole-of-Government response to Brexit, the PSI has considered a broad array of challenges and assessed the risks that generally and particularly relate to our work and the wider health and pharmacy sector. 

The United Kingdom (UK) left the European Union (EU) on 1 February 2020 with a transition period which ended on 31 December 2020. Following the UK decision to leave the EU, the PSI engaged with government departments, regulatory counterparts in the UK, and others in relation to changes that will impact on the PSI’s functions, and the wider health and pharmacy environment.  

Recognition of qualifications

The PSI is responsible as the competent authority in Ireland for the recognition of pharmacist qualifications. To recognise a qualification, the PSI must be able to verify that pharmacists have attained the necessary standard of academic and practical training, amongst other requirements. Pharmacists must obtain recognition of a qualification appropriate for practice before being able to apply to register. The PSI operates three routes of recognition/registration to the pharmacist register.

The legal basis underpinning the recognition of qualifications between Ireland and the UK has changed following Brexit. From 1 January 2021 all UK and Northern Ireland (NI) applicants are required to apply for qualification recognition and registration via the Third Country route (Qualification obtained outside the EU). These applicants who hold a qualification gained in the UK or NI, which would but for the fact that these are no longer members of the European Union, be subject to Automatic Recognition under the Professional Qualifications Directive, and who can satisfy the PSI of this, may be able to proceed to recognition in a one step process under Rule 18 (1). Further details are available on this page for applicants from UK and Northern Ireland, who wish to be considered under Rule 18 (1).

Already registered with a UK qualification in Ireland?

Pharmacists with a UK qualification already recognised and registered in Ireland by the PSI will have no change in registration status. Pharmacists already registered will remain on the register.

National position on medicines

The Department of Health, together with the HPRA, the HSE, and many others has been working to protect the availability of medicines for Irish patients post-Brexit, acknowledging the extent of medicines moved through the UK to get to Ireland.

It has been clearly stated by the Department of Health that hospitals, pharmacists or patients should not order extra quantities of medicines, or for doctors to issue multiple prescriptions for the same medication. The impact of doing so will have a knock-on effect on managing existing stock levels and hamper the supply of medicines for other patients. All involved must balance the interests of their patients and wider society where challenges may arise. Pharmacists and other health professionals have an important role to play in providing accurate information to people to avoid disruption and aid understanding of Ireland’s medicines supply arrangements.

The Department of Health has outlined on their website that Ireland is unlikely to face an immediate impact on medicine supplies in the period immediately following Brexit. This is because there are already additional stocks of medicines routinely built into the Irish medicine supply chain. Shortages exist already in the market, without any relation to Brexit, and the existing Medicine Shortages Framework in place by the HPRA will continue to be used to manage shortages and seek to reduce the impact on patients and healthcare professionals.

Access to cross-border health services and validity of UK prescriptions are all part of Government contingency planning with the latest information available on www.gov.ie/Brexit

Other considerations

The European Commission may adopt adequacy decisions to confirm, with binding effect on EEA countries, that the level of data protection in a non-EEA country is essentially equivalent to the level of protection in the EEA. 

The European Commission adopted two adequacy decisions in June 2021 in relation to the United Kingdom. These decisions mean that data flows between the EEA and the UK can continue without additional safeguards. In other words, transfers of data between the UK and the EEA are comparable to transfers of data within the EEA.

The PSI is maintaining close engagement with all relevant parties in relation to these and other matters and will provide information as it arises to PSI registrants. We aim to keep this webpage updated with information as it is made available.


Frequently Asked Questions (FAQs)

Yes, the PSI has three routes of qualification recognition: national route, EU/EEA route, and third country route. After 1 January 2021, and until further notice, those applicants holding a qualification gained in the United Kingdom or Northern Ireland, which would, but for the fact that these are no longer members of the European Union, be subject to Automatic Recognition under the Professional Qualifications Directive, and who can satisfy the PSI of this, may be able to proceed to recognition in a one step process under Rule 18 (1)

Pharmacists with a UK qualification already recognised and registered in Ireland by the PSI will continue to be registered once they are compliant with the PSI's continued registration requirements. All registered pharmacists must apply for continued registration annually, regardless of where their qualification was obtained.

Further information is available for anyone who holds, or is studying for, a UK qualification in pharmacy and would like to register with the PSI.

The PSI has three routes of qualification recognition: national route, EU/EEA route, and third country route. After Brexit you may still have your qualification recognised. From 1 January 2021 all UK and Northern Ireland applicants will be required to apply via the Third Country route. After this date, and until further notice, those applicants holding a qualification gained in the UK or NI, which would, but for the fact that these are no longer members of the European Union, be subject to Automatic Recognition under the Professional Qualifications Directive, and who can satisfy the PSI of this, may be able to proceed to recognition in a one step process under Rule 18 (1)

The Department of Health and Social Care in the UK has introduced the European Qualifications (Health and Social Care Professions) (Amendment etc.) (EU Exit) Regulations 2019. It sets out what will happen in relation to the recognition of professional qualifications obtained in the EU (i.e. Ireland).

Pharmacists wishing to practice in Northern Ireland should contact the Pharmaceutical Society of Northern Ireland.

Pharmacists wishing to practice in England, Scotland, and Wales should contact the General Pharmaceutical Council.

Further information on Brexit matters in the UK can be found on the Royal Pharmaceutical Society website.

Yes. The Department of Health has amended the Medicinal Products (Prescription and Control of Supply) Regulations 2003 (as amended), to enable the recognition of prescriptions written in the UK by registered medical practitioners, registered dentists and registered nurse prescribers, including midwife prescribers, for dispensing in the State. The Regulations came into effect on 1 January 2021. This is on the provision that the prescription has not been issued with a view to enabling the supply of a medicine by mail order and the prescription has not been issued by means of information society services (Further information can be found below).

The prescription must meet the same legal requirements, as those already in place for a prescription issued by a relevant practitioner practicing in another EEA state.

In accordance with the Code of Conduct for Pharmacists, a pharmacist must always put the patient first and make their health, wellbeing and safety his or her primary focus. As well as the requirements detailed in the legislation, the pharmacist must be satisfied as to the authenticity, content and, more importantly, that it is safe and appropriate to dispense the medicine for the individual patient. If the prescription does not meet the legal requirements or you are not satisfied that the medicine is appropriate for the patient, you should explain this to the patient and refer them to another appropriate healthcare professional or service for further care.

In addition, please note:

  • The original prescription must be presented in the pharmacy. A fax or scanned copy of a prescription is not a legally valid prescription. Electronic prescriptions are not currently supported by the current legislation in Ireland.
  • Products classified as schedule 2, schedule 3 or schedule 4 part 1 controlled drugs may not be prescribed by practitioners registered in the UK for dispensing in Ireland, and such prescriptions may not be used to authorise the supply of any such controlled drug.
  • The product prescribed must be licensed in Ireland.

In practice this means that cross-border telemedicine services is prohibited by law. For example, a prescription that comes from an online doctor service where the prescriber is based in the UK will no longer be valid for dispensing in a pharmacy registered in Ireland.

It is up to the pharmacist to use their professional judgement to identify any prescriptions that fall into this category. This could be done, for example, by discussing with the patient the method of consultation, and using the work address, email address and telephone number of the person issuing the prescription (as required for a valid prescription from a doctor registered in the EEA or UK).

No. It is prohibited (as per Regulation 19A(8) of the Medicinal Products (Prescription and Control of Supply) Regulations 2003 (as amended)) to sell and supply non-prescription medicines at a distance by means of information society services to a member of the public in the UK. This prohibits the sale or supply of non-prescription medicines over the internet from a pharmacy listed on part A of the PSI’s Internet Supply List, or a non-pharmacy listed on Part B of the of the Internet Supply List to a patient/customer in the UK (as is currently the case for supply to a customer in a country outside the EEA).

Yes. Access to cross-border health services are all part of Government contingency planning with the latest information available on Gov.ie.

Brexit has not had any immediate impact on the supply of medicines as there are already additional stocks of medicines routinely built into the Irish medicine supply chain. The Department of Health, together with the HPRA, the HSE and many others, continues working to protect the availability of medicines for Irish patients, acknowledging the extent of medicines moved through the UK to get to Ireland.

Ireland is unlikely to face general medicine supply issues while normal use of medicines is maintained. The Department of Health has clearly stated that hospitals, pharmacists or patients should not order extra quantities of medicines, and doctors should not issue multiple prescriptions for the same medication. The impact of doing so will have a knock-on effect on managing existing stock levels and hamper the supply of medicines for other patients. All involved must balance the interests of their patients and wider society where challenges may arise. Pharmacists and other health professionals have an important role to play in providing accurate information to people to avoid disruption and aid understanding of Ireland’s medicines supply arrangements.

Shortages exist already in the market, without any relation to Brexit. The HPRA’s Medicine Shortages Framework will continue to be used to manage these shortages and seek to reduce the impact on patients and healthcare professionals.

Access to cross-border health services and validity of UK prescriptions are all part of Government contingency planning with the latest information available on www.gov.ie/Brexit


Further information