John Lahart (Dublin South West, Fianna Fail)
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326. To ask the Minister for Health the reason that mandatory hotel quarantine is required for a WHO approved vaccine (details supplied); and if he will make a statement on the matter. [30921/21]

Paul Murphy (Dublin South West, RISE)
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341. To ask the Minister for Health the reason mandatory hotel quarantine is required for a WHO approved vaccine when there is no liability in the event of side effects as the State has not supplied a vaccine (details supplied); and his views on whether the State’s concern should be with the performance of the vaccine which has received WHO acceptance. [30967/21]

Stephen Donnelly (Wicklow, Fianna Fail)
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I propose to take Questions Nos. 326 and 341 together.

Ireland procures COVID-19 vaccines through its participation in an EU procurement process and their approval is by the Commission following recommendation by the EMA.

At present, the Sinopharm vaccine has not received EMA approval.

COVID-19 vaccines can only be approved and used if they comply with all the requirements of quality, safety and efficacy set out in the EU pharmaceutical legislation. No vaccine will be used until Market authorisation from the European Medicines Agency (EMA) is obtained and any authorised vaccine will be subject to ongoing monitoring in Ireland by the Health Product Regulatory Authority (HPRA).

Passengers who are fully vaccinated in accordance with the table below and have the documents to confirm this are not required to complete mandatory hotel quarantine on arrival in Ireland. Dependents, including children, will also be exempted from the requirement to complete mandatory hotel quarantine.

What 'fully vaccinated' means: