Hpra.ie

The Health Products Regulatory Authority

WEBSafety Notices. Recall. 02.04.2024. Recall of one batch of Duloxetine Accord 30 mg hard gastro-resistant capsules and one batch of Duloxetine Accord 60 mg hard gastro …

Actived: Just Now

URL: https://www.hpra.ie/

Guide to Control and Monitoring of Storage and …

WEBIA-G0011-3 2 OCTOBER 2020 This guide does not purport to be an interpretation of law and/or regulations and is for guidance purposes only. Guide to

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Regulatory Information

WEBThe objective of the Health Products Regulatory Authority is to ensure in so far as possible, consistent with current medical and scientific knowledge, the quality, safety and efficacy …

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Guide to Good Distribution Practice of Medicinal Products for …

WEBHPRA Guide to Good Distribution Practice of Medicinal Products for Human Use IA-G0046-7 4/37 ‘Brokering of medicinal products’ means all activities in relation to the sale or …

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Biological and biosimilar medicines

WEBThe objective of the Health Products Regulatory Authority is to ensure in so far as possible, consistent with current medical and scientific knowledge, the quality, safety and efficacy …

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Single Use & Single Patient Use Medical Devices

WEBA ‘single use device’ is defined under Directive 2007/47/EC, the amendment to the Medical Device Directive 93/42/EEC, where it states that: “single use device" means a device …

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Drug Safety Information for Healthcare Professionals

WEBSafety Communications. A core goal of the HPRA is to ensure that all our stakeholders have timely access to relevant information on safety issues or benefit/risk evaluations of …

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About this Legislation

WEBAbout the Emergency Medicines Legislation. Legislation (SI 449 of 2015) has been introduced to allow for trained non-medical persons to administer specific prescription …

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Controlled Substances

WEBThe objective of the Health Products Regulatory Authority is to ensure in so far as possible, consistent with current medical and scientific knowledge, the quality, safety and efficacy …

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Multiple Issues Identified in Atellica Solution System Software …

WEBThis response form is to confirm receipt of the enclosed Siemens Healthcare Diagnostics Urgent Field Safety Notice (UFSN) ASW19-04.A.OUS, dated March, 2019 titled “Multiple …

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Medicines Shortages

WEBEarlsfort Terrace, Dublin 2. Tel: +353 1 676 4971. Fax: +353 1 676 7836. [email protected]. The objective of the Health Products Regulatory Authority is to …

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Cariban 10 mg/10 mg modified-release hard capsules

WEBThe objective of the Health Products Regulatory Authority is to ensure in so far as possible, consistent with current medical and scientific knowledge, the quality, safety and efficacy …

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