Brexit has implications for the life sciences and healthcare sectors in Ireland, particularly in relation to supply chains and regulatory requirements.
There are a number of steps that healthcare providers, manufacturers and wholesalers can and are taking to minimise any impact on their operations.
These include new regulatory requirements given that the UK is now a third country and no longer in the single market or part of the European Medicines Regulatory Network. It is important that you familiarise yourself with these new requirements.
The HPRA continues to advise suppliers to engage at the earliest opportunity if they believe that Brexit may impact on their ability to supply a health product to the Irish market. Suppliers are asked to contact the HPRA regarding any issues or concerns by emailing info@hpra or calling +353 1 676 4971.
Access to Medicines
The sale and supply of medicines to and from the UK continues as normal. The manufacturers of medicines, wholesalers and pharmacists, are working closely with Government in this area and, as a result, there is no evidence to suggest that Ireland is likely to face general medicines supply issues, now or in the near future.
All stakeholders will continue to closely monitor supplies and will put any additional arrangements in place as necessary. This includes time- and temperature- sensitive medicines. Some of our medicines come from or through the UK to get to Ireland. However, medicines manufactured in the UK can continue to be supplied to the EU as long as they continue to meet EU standards.
For medicines coming through the UK, Ireland is well placed to maintain the general supply of medicines. This is because medicines are not normally subject to Free Trade Agreements or checks at borders. There are already additional stocks of medicines routinely built into the Irish medicine supply chain to address any initial delays at ports, should they occur.
You do not need to order extra quantities of medicines or extra prescriptions. If you do, you could disrupt existing stock levels and hamper the supply of medicines for other patients. Anyone with an ongoing need for medicines should fill their prescription as normal.
Customs and logistics
Medicines and medical devices are not normally subject to checks at borders. However, the key risk to supply is the potential delays at customs. Companies have been engaging in extensive Brexit planning for the last several years and arrangements are in place to ensure continuity of supply.
Revenue Customs has arrangements in place to facilitate the movement of medicines from non-EU countries through the port/airport. This involves the submission of documentation by the agent / company in advance of the arrival of the consignment to facilitate a risk assessment by customs. Companies submit in advance the following documentation:
Single Administrative Document (SAD) form (including CN codes)
Electronic risk assessments are performed by customs in advance of the goods arriving. Currently there are no risk profiles associated/applied to medicines. If all the above-mentioned documentation is in order, and there is no risk profile associated with the company sending or receiving the product, then these consignments are ‘green-routed’.
This means that they will normally not be subject to physical checks on arrival, and they are free to flow through customs in the same way as they currently do within the EU.
However, if your goods are carried in mixed loads this may lead to delays if the other goods are subject to physical inspection or SPS checks.
Regulatory, certification and operational implications
Medicines and medical products are highly regulated. There are a number of EU and national regulations in place to ensure high product standards and safety. Even under the Trade and Cooperation Agreement between the EU and UK there will be regulatory and operational impacts for medicines and medical devices that are wholly- or part- produced in the UK.
The HPRA, the national competent authority for medicines, is supporting stakeholders in managing the regulatory and operational implications arising from Brexit. For further information, visit the HPRA .
Companies exporting medicines to the UK may be subject to new or different regulatory requirements over time. Companies will also have to ensure they comply with any new checks and controls that the UK may put in place. You are also advised to contact any professional bodies that you are a member of to see if they have additional advice on preparing for Brexit.
All medical devices on the EU market must be certified by EU-based notified bodies. UK bodies will no longer have the authority to issue such certificates, and existing certificates may no longer be valid. For further information, visit the HPRA. This is an issue that affects all EU Member States. See here for more information on certification and regulation. for further information.
Companies exporting medical devices to the UK may be subject to new or different regulatory requirements over time. Businesses are also advised to engage with any trade representative body of which they are a member and which can assist them in preparing for Brexit. Companies will also have to ensure they comply with any new checks and controls that the UK may put in place.
The UK is no longer bound by EU rules, therefore, the EU Directive on the Recognition of Professional Qualifications, which allowed for Irish and UK citizens to have their professional qualifications (including many health qualifications) mutually recognised, no longer applies.
It is important to be aware that persons who had their UK professional qualifications recognised in Ireland before the end of the transition period are not affected by this change and vice versa (where persons had Irish professional qualifications recognised in the UK). This includes applications in the process of being recognised when the transition period ended.
From January 2021, all applications for the recognition of UK health and social care qualifications in Ireland will be processed as ‘third country’ applications, similar to all applications from outside the EEA. This should have no discernible effect on the application process in the majority of cases. However, in a small number of cases, the process might take longer than was the case under the Directive.
Further information on individual health professions can be found on the relevant regulator’s website.