Medicines: COVID-19 Updates

The HPRA will provide information and updates on this webpage related to COVID-19 and the regulation of medicines. 

During this time, the vast majority of HPRA staff are working remotely. Where possible, please correspond with us by e-mail using existing HPRA staff e-mail contacts or via relevant mailboxes. Please see Contacting the HPRA during the COVID-19 Response for additional details, including emergency contacts.

For an overview of how the HPRA is responding to the challenges presented by COVID-19, please see our infographic.

Regulatory Expectations  

See details in relation to the regulatory expectations and flexibilities available to MAHs to maintain medicines on the EU market during the COVID-19 pandemic.

Latest Updates 

The most recent updates are listed first. Please click on an item to see more information.

18 May 2020 — Variation Implementation Times for Labelling and Leaflet Updates to Human Medicines

The HPRA has agreed to extend the permitted implementation time from six months to nine months for labelling and/or package leaflet updates following variation approval for the duration of the COVID-19 pandemic. This is a temporary measure only and it will be kept under review. The HPRA has taken this decision to help maintain medicines availability in Ireland during this exceptional time.

It is important to highlight that this extension to nine months does not apply to the implementation of significant safety updates to the labelling and/or package leaflet. Significant safety updates will still need to be implemented within the six-month timeframe. The marketing authorisation holder (MAH) is therefore advised to carry out an evaluation of the specific nature of the updates to the labelling and/or package leaflet before allowing the extended implementation period.

More information is available in our news item.

18 May 2020 — Global regulators work towards alignment on policy approaches and regulatory flexibility during COVID-19

The International Coalition of Medicines Regulatory Authorities (ICMRA) convened a virtual meeting of regulators from around the world on 14 May 2020 to discuss high-level policy issues and regulatory requirements to respond to the ongoing COVID-19 pandemic. The strategic meeting underlined the need and commitment by global regulators to cooperate and align their approaches to clinical trial management, medicine supply issues and pharmacovigilance in light of the medical emergency presented by COVID-19.

This was the third in a series of bi-weekly ICMRA meetings organised to allow medicine regulators worldwide to exchange information and build synergies for expediting COVID-19 medicine and vaccine development and approval and for preventing and mitigating medicine shortages. These strategic discussions build on the knowledge and experience gained from the series of ICMRA workshops on COVID-19 medicine development held in March and April 2020.

Visit the EMA website for further details.

The HPRA is a member of ICMRA, which acts as a forum to support international cooperation among medicines regulatory authorities. Further details on the role and strategic initiatives of ICMRA can be found on www.icmra.info.

15 May 2020 — EU actions to support availability of medicines during COVID-19 pandemic – update #6

The EU Executive Steering Group on Shortages of Medicines Caused by Major Events held a virtual meeting on 13 May 2020. Participation to the meeting of the steering group was extended to all the heads of the national competent authorities (NCAs) of the EU Member States to discuss the measures taken by EU authorities to ensure the continued availability of medicines in Europe during the ongoing COVID-19 pandemic.

Further details of the matters discussed during this meeting can be found on the EMA website.

Previous EMA updates relating to the availability of medicines during the COVID-19 pandemic are also available on the EMA website.

5 May 2020 — Global regulators work towards alignment on policy approaches and regulatory flexibility during COVID-19

In a high-level meeting on COVID-19 policies organised under the umbrella of the International Coalition of Medicines Regulatory Authorities (ICMRA), international regulators from around the world discussed strategic issues and regulatory approaches to ensure a coordinated response to the pandemic. They stressed the need for alignment on pre- and post-authorisation regulatory requirements to facilitate the rapid development, evaluation and availability of medicines for the treatment and prevention of coronavirus disease.

The participants focused on regulatory considerations and challenges related to the development of medicines and vaccines for the prevention and treatment of COVID-19. The regulators reiterated that it is crucial to align on common study protocols to ensure that the results meet regulatory requirements and allow the evidence to be used to support the approval of medicines or vaccines.

Regulators also discussed the development, evaluation and use of diagnostic tests in the fight against coronavirus disease.

This was the second in a series of bi-weekly ICMRA meetings organised to allow medicine regulators worldwide to exchange information and build synergies for expediting COVID-19 medicine and vaccine development and approval and for preventing and mitigating medicine shortages. These strategic discussions build on the knowledge and experience gained from the series of ICMRA workshops on COVID-19 medicine development held in March and April 2020. The EMA and FDA are taking it in turns to chair these meetings. Further details can be found on the EMA website.

The HPRA is a member of ICMRA, which acts as a forum to support international cooperation among medicines regulatory authorities. Further details on the role and strategic initiatives of ICMRA can be found on www.icmra.info.

4 May 2020 — Regulatory flexibility to ensure availability of veterinary medicines during COVID-19 pandemic

The European Commission, EMA and the CMDv (Coordination Group for Mutual Recognition and Decentralised Procedure – Veterinary) have issued guidance on adaptations to the regulatory framework to companies that develop, manufacture and distribute veterinary medicines in order to address some of the constraints posed by the COVID-19 pandemic.

According to the jointly developed question-and-answer (Q&A) document, regulatory rules for veterinary medicines should be applied with greater flexibility in the context of COVID-19 when necessary to mitigate the risk of supply disruptions caused by the pandemic. The guidance aims to ensure that high-quality, safe and effective veterinary medicines that are essential for protecting public and animal health continue to be available during the public health crisis.

Further details can be found on the EMA website.

30 April 2020 — European Medicines Agency starts rolling review of remdesivir for COVID-19

The EMA’s human medicines committee (CHMP), of which the HPRA is a member, has started a ‘rolling review’ of data on the use of the investigational antiviral medicine remdesivir for the treatment of coronavirus disease (COVID-19).

The start of the rolling review only means that the evaluation of remdesivir has started and does not imply that its benefits outweigh its risks.

A rolling review is one of the regulatory tools available to the Agency to speed up the assessment of a promising investigational medicine during a public health emergency, such as the ongoing pandemic.

While the overall review timeline for remdesivir cannot be anticipated at this moment, it is expected that this procedure will allow EMA to complete its assessment significantly earlier compared with a regular evaluation procedure, while still ensuring a robust scientific opinion is reached.

Further details can be found on the EMA website.

30 April 2020 — Update on Plans for Ending Safety Features Use and Learn in Ireland

In light of the COVID-19 pandemic, the Safety Features Oversight Group has reviewed plans to end the Falsified Medicines Directive "use and learn" period on a phased basis. It has been decided to delay plans to end the "use and learn" period for wholesalers in May and for pharmacies and hospitals in September.

New dates will be notified in due course. In the meantime, the advice is as follows:

  1. If you have any queries about your FMD obligations, please contact the PSI (Retail Pharmacy Businesses), HSE FMD project team (public hospitals), HPRA (wholesalers, MAHs, manufacturers, parallel importers, parallel distributors).

  2. Parallel importers and parallel distributors should continue to comply with the guidance issued to them by the HPRA on 7 February 2020.

  3. Please contact IMVO if you have queries about your connection to the national system (including new registrations, login queries, change of FMD software provider) or want to follow up on specific alerts or scanning issues.

  4. If at any stage you have grounds for believing that a pack has been interfered with or could be falsified, please report this to the HPRA, by email to qualitydefects@hpra.ie or using the HPRA’s online reporting system.

Further information is available in our website section on Falsified Medicines Legislation.

24 April 2020 — Reporting suspected side effects of medicines in patients with COVID-19

The HPRA, together with other national competent authorities and the European Medicines Agency, is reminding patients with confirmed or suspected coronavirus disease (COVID-19) to report suspected side effects that they experience with any of the medicines they are taking. This includes medicines to treat COVID-19, as well as medicines taken by patients to manage long-term, pre-existing conditions. It also includes medicines that patients might be using off-label to treat COVID-19.

Patient reporting complements the information received from healthcare professionals and will add to the knowledge currently being generated through clinical trials and other studies.

Patients and healthcare professionals can report suspected side effects directly to the HPRA using our online reporting system or to the manufacturer of the medicines using the instructions in the patient leaflet.

View further information on how and what to report.

24 April 2020 — HPRA Update: Regulatory Expectations During the COVID-19 Pandemic

The European Commission has published a Questions and Answers document for medicinal products for human use detailing regulatory expectations and flexibilities available to MAHs to maintain medicines on the EU market during the COVID-19 pandemic.

To interpret the practical aspects of the Commission document for MR/DCP products, the CMDh has also published a practical guidance document to facilitate the handling of processes during the COVID-19 response. It provides further direction on how to request and apply the provisions as set out by the Commission.

The HPRA has now published additional information nationally for those applicants who consider that they have a need for regulatory flexibility in relation to the COVID-19 pandemic. This includes information on the Exceptional Change Management Process (ECMP) and details of the contact points for applicants to submit their further requests. Please ensure that such communications include the prescribed headings for MR/DCP applications as per CMDh practical guidance.

23 April 2020 — European Medicines Agency issues reminder of risk of serious side effects with chloroquine and hydroxychloroquine

Chloroquine and hydroxychloroquine are known to potentially cause heart rhythm problems, and these could be exacerbated if treatment is combined with other medicines, such as the antibiotic azithromycin, that have similar effects on the heart.

The COVID-19 EMA pandemic Task Force (COVID-ETF) has published a public health statement in consultation with the EMA’s safety Committee (PRAC), in light of the ongoing discussions on the use of chloroquine and hydroxychloroquine in the treatment of COVID-19.

Recent studies have reported serious, in some cases fatal, heart rhythm problems with chloroquine or hydroxychloroquine, particularly when taken at high doses or in combination with the antibiotic azithromycin.

These medicines are being used in the context of the ongoing pandemic for treating patients and are being investigated in clinical trials. However, clinical data are still very limited and inconclusive, and the beneficial effects of these medicines in COVID-19 have not been demonstrated. Results from large, well-designed studies are needed to make any conclusions.

Some clinical trials currently investigating the effectiveness of chloroquine or hydroxychloroquine in treating COVID-19 use higher doses than those recommended for the authorised indications. While serious side effects can occur with recommended doses, higher doses can increase the risk of these side effects, including abnormal electrical activity that affects the heart rhythm (QT-prolongation).

Healthcare professionals are recommended to closely monitor patients with COVID-19 receiving chloroquine or hydroxychloroquine and to take into account pre-existing heart problems that can make patients more prone to heart rhythm issues. They should carefully consider the possibility of side effects, particularly with higher doses, and exercise extra caution when combining treatment with other medicines such as azithromycin that may cause similar side effects on the heart.

Further information is available on the EMA website.

The EMA and the national competent authorities are monitoring the situation closely and have enhanced their safety monitoring of medicines used in the treatment of COVID-19 in order to take timely action when necessary. The European regulatory network is committed to providing available information to help healthcare professionals and their patients make informed decisions while awaiting clinical trial data on whether the medicines have a positive benefit-risk balance in the treatment of COVID-19.

21 April 2020 — Launch of enhanced monitoring system for availability of medicines used for treating COVID-19

The EMA and EU Member States, together with the pharmaceutical industry, have launched an enhanced fast-track monitoring system to help prevent and mitigate supply issues with crucial medicines used for treating patients with COVID-19.

Under this system, each pharmaceutical company will appoint a single contact point (an industry single point of contact, or i-SPOC) who will report to EMA and national competent authorities all current and anticipated shortages of medicines used in patients with COVID-19, both for centrally and nationally authorised medicines.

The new mechanism will allow better oversight of ongoing supply issues and a quicker flow of information between regulatory authorities in the EU and the pharmaceutical industry with the objective of mitigating and preventing shortages of medicines used during the COVID-19 health emergency.

20 April 2020 — Update to guidance on regulatory expectations in the context of COVID-19 pandemic: Measures agreed to mitigate the impact of disruptions to the conduct of on-site inspections

The European Commission, EMA and the national competent authorities have agreed a series of measures to mitigate the impact of disruptions caused by COVID-19 on the conduct of inspections of manufacturing facilities or other sites relevant for medicinal products in the European Union.

Current national and international safety measures and travel restrictions affect or prevent the conduct of on-site inspections related to good manufacturing (GMP) and distribution practice (GDP). The mitigation measures have been taken to ensure the continued availability of medicines while making sure that good practice standards are being adhered to. This is achieved through proportionate approaches to verification of standards by enabling remote assessments of compliance.

Details of the new measures are included in an update to the question-and-answer (Q&A) document, developed jointly by the European Commission, EMA and the Heads of Medicines Agencies (HMA), to provide guidance to stakeholders on adaptations to the regulatory framework to address COVID-19 challenges.

Further details can be found on the EMA website.

9 April 2020 — Global regulators discuss observational studies of real world data for COVID-19 medicines

In a dedicated COVID-19 workshop convened on 6 April under the umbrella of the International Coalition of Medicines Regulatory Authorities (ICMRA), international regulators discussed how data generated during clinical practice could complement evidence from clinical trials with potential therapeutics or vaccines against COVID-19. Participants from more than 25 countries, representing 28 medicines regulatory authorities globally and experts from the World Health Organization and the European Commission contributed to the workshop. Together, they acknowledged the importance of observational studies of real world data for increasing the effectiveness and efficiency of regulatory processes and decision-making in the development, authorisation and monitoring of medicines and vaccines to prevent and treat COVID-19 and to address knowledge gaps that cannot be addressed by clinical trials.

Visit the ICMRA website to learn more about this recent workshop.

The HPRA is a member of ICMRA, which acts as a forum to support international cooperation among medicines regulatory authorities. Further details on the role and strategic initiatives of ICMRA can be found on www.icmra.info.

10 April 2020 — Guidance on regulatory requirements in the context of the COVID-19 pandemic

The European Commission, EMA and national medicines authorities have developed a question-and-answer (Q&A) document to provide guidance to stakeholders on adaptations to the regulatory framework to address challenges arising from the COVID-19 pandemic, with a particular focus on crucial medicines for use in COVID-19 patients.

The current pandemic is a global public health emergency causing major disruptions that impact citizens, patients and businesses, including the activities of pharmaceutical companies. The document explains some regulatory flexibilities that can be applied to help pharmaceutical companies cope with the consequences of the pandemic, while ensuring a high level of quality, safety and efficacy for medicinal products made available to patients in the EU.

9 April 2020 — Global regulators stress need for robust evidence on COVID-19 treatments

International regulators have published a report today highlighting their considerations on the development of potential COVID-19 therapeutics, clinical trials and compassionate use programmes. The report presents the outcomes of a workshop on COVID-19 therapeutic medicine development that was convened under the umbrella of the International Coalition of Medicines Regulatory Authorities (ICMRA).

At this point in time, no medicine has yet clearly demonstrated efficacy in treating COVID-19. Workshop participants stressed that the fastest way to serve patients was to collect robust evidence to determine which investigational agents or repurposed medicines would be safe and effective for the treatment of COVID-19. Regulators agreed that multi-centre randomised controlled studies are the best way to generate the data required to enable rapid development and approval of potential treatments for COVID-19. They also agreed on a harmonised approach to make best use of the available supply. Participants committed to exchange information about the ongoing studies and results to support the global approach.

Visit the ICMRA website to view the report and to learn more about the recent workshop.

The HPRA is a member of ICMRA, which acts as a forum to support international cooperation among medicines regulatory authorities. Further details on the role and strategic initiatives of ICMRA can be found on www.icmra.info.

6 April 2020 — Medicines Applications Submitted via Post during the COVID-19 Response

The offices of the HPRA are temporarily closed with all staff working remotely. We therefore request that, where possible, CD/DVD/hardcopy applications are submitted electronically via CESP or to submissions@hpra.ie.

If you have any regulatory queries specific to COVID-19, please e-mail covid19@hpra.ie, inserting COVID-19 into the subject line. See also Contacting the HPRA during the COVID-19 Response for more information about contacting us during this time. 

6 April 2020 — EMA update: EU authorities agree new measures to support availability of medicines used in the COVID-19 pandemic

The European Medicines Agency (EMA) has issued information regarding new measures to support the availability of medicines. The continued availability of medicines, in particular those used for patients with COVID-19, is of critical concern for the EMA and its partners in the European medicines regulatory network in light of the medical emergency presented by the pandemic.

In the context of the pandemic, the EMA and the EU network are considering mitigation measures such as regulatory actions to support increased manufacturing capacities, e.g. through speeding up the approval of a new manufacturing line or site. Discussions are also ongoing with the pharmaceutical industry to increase production capacity for all medicines used in the context of COVID-19, and in particular for medicines potentially at risk of supply shortages.

In addition, the EU Executive Steering Group is considering areas where regulatory rules could be applied with greater flexibility during the pandemic to secure supply of critical medicines. Further information will be given in a question-and-answer document, currently under development.

More information is available on the EMA website

1 April 2020 — EMA update: Chloroquine and hydroxychloroquine only to be used in clinical trials or emergency use programmes

The European Medicines Agency (EMA) has issued an update in relation to chloroquine and hydroxychloroquine. The two medicines, which are currently authorised for malaria and certain autoimmune diseases, are being investigated worldwide for their potential to treat COVID-19. However, efficacy in treating COVID-19 is yet to be shown in studies.

According to the EMA statement, it is very important that patients and healthcare professionals only use chloroquine and hydroxychloroquine for their authorised uses or as part of clinical trials or national emergency use programmes for the treatment of COVID-19.

Both chloroquine and hydroxychloroquine can have serious side effects, especially at high doses or when combined with other medicines. They must not be used without a prescription and without supervision by a doctor; prescriptions should not be given outside their authorised uses except in the setting of a clinical trial or nationally agreed protocols.

Large clinical trials are underway to generate the robust data needed to establish the efficacy and safety of chloroquine and hydroxychloroquine in the treatment of COVID-19.

More information, including information for both patients and healthcare professsionals, is available on the EMA website.

31 March 2020 – HSE Advice if you are Taking Medication for other Conditions

The HSE is advising members of the public to continue taking existing medication as usual, unless they are told not to by a healthcare professional. This is in response to reports, for which there is currently no scientific evidence, suggesting certain medication may be unsafe if you have coronavirus.

Additional information in respect of Ibuprofen and other anti-inflammatory medication, high blood pressure medicines, immunosuppressive medicines and treatments, and steroids is available from the HSE website.

31 March 2020 – EMA update on treatments and vaccines against COVID-19 under development  

The European Medicines Agency (EMA) has issued an update in relation to its engagement with developers of therapeutic medicines for COVID-19. The update states that at this point, on the basis of the preliminary data presented to the EMA, no medicine has yet demonstrated efficacy in treating COVID-19.

The EMA has been in contact with developers of around 40 therapeutic medicines. A number of potential treatments for COVID-19 are currently undergoing clinical trials to assess their safety and efficacy against the disease.

The EMA update also states that two vaccines have entered Phase I clinical trials. Based on the information currently available and past experience with vaccine development timeframes, the EMA estimates that it might take at least one year before a vaccine against COVID-19 is ready for approval and available in sufficient quantities to enable widespread use.

The EMA will continue to interact with developers of potential therapeutics or vaccines against COVID-19. The aim is to provide advice on regulatory requirements so that any promising medicinal product can be made available as rapidly as possible to patients.

More information is available on the EMA website.

27 March 2020 – EMA advises continued use of medicines for hypertension, heart or kidney disease during COVID-19 pandemic

The European Medicines Agency (EMA) has stated it is aware of recent media reports and publications which question whether some medicines, for instance angiotensin converting enzyme (ACE) inhibitors and angiotensin receptor blockers (ARBs, or sartan medicines), could worsen coronavirus disease (COVID-19). ACE inhibitors and ARBs are most commonly used for treating patients with high blood pressure, heart failure or kidney disease.

According to the EMA, it is important that patients do not interrupt their treatment with ACE inhibitors or ARBs and there is no need to switch to other medicines. There is currently no evidence from clinical or epidemiological studies that establishes a link between ACE inhibitors or ARBs and the worsening of COVID-19. Experts in the treatment of heart and blood pressure disorders, including the European Society of Cardiology, have already issued statements along those lines. To gather more evidence, EMA is proactively reaching out to researchers working to generate further evidence in epidemiological studies.

Additional information is available on the EMA website. See similar advice below issued by the HPRA on 16 March. Any changes to the regulatory position will be published on the HPRA website. The HSE has also published advice on this matter for members of the public on its website. Healthcare professionals should refer to the HSE website for up-to-date clinical guidelines.

25 March 2020 – COVID-19: Postponement of all routine compliance inspections until further notice

The HPRA has postponed all routine compliance inspections at the regulated sites until further notice and has informed all sites that would have received an inspection notice. The conduct of triggered and EMA requested inspections will be decided on a case-by-case basis and may be conducted remotely. Should we believe an urgent on-site inspection is necessary, the HPRA will follow public health advice in relation to any required precautions.

If you have any GxP-related questions or communications, please email: compliance@hpra.ie.

24 March 2020 – Keeping Safe when Buying Medicines

The European Medicines Agency (EMA) is urging European consumers not to buy medicines from unauthorised websites and other vendors aiming to exploit fears and concerns during the ongoing pandemic of coronavirus disease (COVID-19). There are no authorised medicines to prevent or treat COVID-19 and members of the public should not buy medicines advertised as such online. If you have symptoms, you should contact your doctor and follow advice from health authorities.

Vendors may claim that their products can treat or prevent COVID-19 or may appear to provide easy access to legitimate medicines that are otherwise not readily available. Such products are likely to be falsified medicines. Falsified medicines are fake medicines that vendors pass off as real or authorised. Taking such products can lead to severe health problems or a worsening of your condition.

18 March 2020 – Guidance on Regulatory Submissions during COVID-19

The HPRA acknowledges the potential impact of COVID-19 on the health system and broader society, and the impact it may have on medicinal product licenses (product authorisations). The HPRA appreciates that the situation is evolving, and that additional actions are required to deal with the challenges of issuing, maintaining and updating product authorisations.

Under the current circumstances, HPRA will give priority review to any submission relating to COVID-19. In order to assist HPRA in the identification of such submissions, the cover letter associated with the submission should be clearly marked “COVID-19 relevant”; a justification as to why the submission is COVID-19 relevant should also be included in the cover letter. Furthermore, the email sent to submissions@hpra.ie should also be clearly marked “COVID-19 relevant” in the subject line. These actions by our stakeholders will ensure appropriate prioritisation of assessment, which may be expedited in line with national and/or EU legal frameworks.

The offices of the HPRA are temporarily closed with all staff working remotely. We therefore request that, where possible, applications are not sent by post. Please submit CD/DVD/hardcopy applications electronically via CESP or to submissions@hpra.ie.

The HPRA is committed to providing all necessary support during this time, and will provide further guidance as required.

18 March 2020 – European Medicines Agency gives advice on the use of non-steroidal anti-inflammatories for COVID-19

The European Medicines Agency (EMA) has issued advice today following recent reports, especially on social media, which raise questions about whether non-steroidal anti-inflammatory medicines (NSAIDs) such as ibuprofen could worsen coronavirus disease (COVID-19).

The EMA has confirmed that there is currently no scientific evidence establishing a link between ibuprofen and worsening of COVID-19. It is monitoring the situation closely and will review any new information that becomes available on this issue in the context of the pandemic.

Further details are available on the EMA website. See similar advice below issued by the HPRA on Monday (16 March). Any changes to the regulatory position will be published on the HPRA website. The HSE has also published advice on this matter for members of the public on its website. Healthcare professionals should refer to the HSE website for up-to-date clinical guidelines.

16 March 2020 – COVID-19 infection: anti-inflammatory and anti-hypertensive medicines

The HPRA is aware of recent reports which question whether some anti-inflammatory and anti-hypertensive medicines could worsen coronavirus disease (COVID-19).

Firstly, in relation to ibuprofen, there is no change to the regulatory advice for its use in approved indications and recent reports in the media are unverified. Both paracetamol and ibuprofen are commonly used for symptomatic treatment of pain and fever.

Secondly, recent scientific articles have suggested possible links between ACE inhibitors and Angiotension II Receptor Blockers (ARBs), and COVID-19 outcomes. These links are theoretical in nature, with some suggesting a risk of complication and others a protective effect for these medicines. There is currently no scientific evidence to support either claim, and patients should not stop taking their medicines on foot of these reports.

The HPRA recommends that members of the public seek advice on their medicines from official sources. Any questions or concerns regarding any medicine you are taking should be discussed with your doctor and/or pharmacist.

Further information is available on the news section of our website.

10 March 2020 – European medicines regulatory network closely monitoring the potential impact of the outbreak of the novel coronavirus disease (COVID-19) on pharmaceutical supply chains

The European Medicines Agency (EMA), the European Commission and the national competent authorities in the Member States are closely monitoring the potential impact of the outbreak of the novel coronavirus disease (COVID-19) on pharmaceutical supply chains into the European Union (EU). There are no reports of current shortages or supply disruptions of medicines marketed in the EU due to Covid-19.

The first meeting of the EU Executive Steering Group on shortages of medicines caused by major events has been organised to discuss measures aimed at addressing the potential impact of the outbreak of COVID-19 on the supply of medicines in the EU. Further information is available from the EMA website.

20 February 2020 – HPRA working with national and international authorities in relation to any potential future impact

The HPRA is actively monitoring the situation in relation to any potential future impact of the outbreak of COVID-19 on the supply chains of medicines and medical devices used in Ireland. There are no current reports of COVID-19 affecting supply. However, the HPRA remains vigilant to any potential risk and will continue to work with other authorities at national, European and international level to closely monitor the situation as regards health products and ensure that all appropriate steps are taken to facilitate continuity of supply.

The HPRA has already contacted all suppliers of medicines to Ireland to highlight the need to review their supply chains in light of COVID-19 and take appropriate steps to ensure continuity of supply. Companies have also been requested to inform the HPRA well in advance in the event of any supply disruptions that they envisage could occur so that alternative medicines can be identified. The HPRA is also closely working with colleagues in the European network including the European Medicines Agency to assess the potential implications for the supply of medicines across Europe.

These initiatives place a priority on the continuity of treatment for Irish patients.


Continuity of Supply of Medicines during COVID-19 Response

The HPRA is working in partnership with the Department of Health, the HSE and healthcare professionals to minimise and proactively address any risks posed to the ongoing of supply of medicines and medical devices to Irish patients. Its work programme involves liaising closely with industry stakeholders including representative bodies, manufacturers and wholesalers, so that there is continued access to the health products that people use and need to treat their conditions.

There are already additional stocks of medicines routinely built into the Irish medicine supply chain which are based on normal use and demand for medicines. Therefore, Ireland is unlikely to face general medicines supply issues now or in the near future as a result of any COVID-19 related issues. There is no need for hospitals or healthcare professionals to order extra quantities of medicines, or for doctors to issue additional prescriptions. Similarly, patients and the general public are asked not to seek supplies of medicines over and above their normal requirements. Doing so will disrupt existing stock levels and hamper the supply of medicines for others.