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    Browsing Health Products Regulatory Authority (HPRA) by Title

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      • Thumbnail

        Guidance for marketing authorisation holders on direct healthcare professional communications

        Irish Medicines Board (IMB) (Irish Medicines Board (IMB), 2010-04)
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        Guidance note for the registration of persons responsible for placing devices on the market in accordance with Directive 93/42/EEC and S.I. No. 252 of 1994

        Irish Medicines Board (IMB) (Irish Medicines Board (IMB), 2004-10-21)
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        Guidance note for the registration of persons responsible for placing in-vitro diagnostic medical devices on the market in accordance with Directive 98/79/EC and S.I. No. 304 of 2001.

        Irish Medicines Board (IMB) (Irish Medicines Board (IMB), 2004-10-21)
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        Guidance notes for manufacturers on clinical investigations carried out in Ireland

        Irish Medicines Board (IMB) (Irish Medicines Board (IMB), 2002-11-06)
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        Guidance on combining parenteral product containers on one product authorisation

        Irish Medicines Board (IMB) (Irish Medicines Board (IMB), 2000)
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        Guide for class I manufacturers on compliance with European Communities (medical devices) regulations, 1994

        Irish Medicines Board (IMB) (Irish Medicines Board (IMB), 2010-08)
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        Guide for medical device manufacturers on auditing by the Irish Medicines Board to the medical device regulations

        Irish Medicines Board (IMB) (Irish Medicines Board (IMB), 2010-08)
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        Guide on completion of the hospital blood bank annual report: completion due 31st January 2008

        Irish Medicines Board (IMB) (Irish Medicines Board (IMB), 2007-11)
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        Guide to batch-specific requests for human medicines

        Irish Medicines Board (IMB) (Irish Medicines Board (IMB), 2008-11-06)
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        Guide to field safety corrective actions for medical devices and in-vitro diagnostic medical devices

        Irish Medicines Board (IMB) (Irish Medicines Board (IMB), 2010-04-06)
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        Guide to incident reporting for general medical devices and active implantable medical devices

        Irish Medicines Board (IMB) (Irish Medicines Board (IMB), 2010-04-06)
      • Thumbnail

        Guide to incident reporting for in-vitro diagnostic medical devices

        Irish Medicines Board (IMB) (Irish Medicines Board (IMB), 2010-04-06)
      • Thumbnail

        Guide to information held by the IMB

        Irish Medicines Board (IMB) (Irish Medicines Board (IMB), 2008-12)
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        Guide to notification of a cosmetic product

        Irish Medicines Board (IMB) (Irish Medicines Board (IMB), 2010-10-01)
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        Guide to refusals and appeals

        Irish Medicines Board (IMB) (Irish Medicines Board (IMB), 2010-11-29)
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        Guide to reporting of quality defects in medicinal products for human and veterinary use

        Irish Medicines Board (IMB) (Irish Medicines Board (IMB), 2010-09-14)
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        Guide to reporting serious adverse reactions (SARs) and serious adverse events (SAEs) associated with human tissues and cells

        Irish Medicines Board (IMB) (2007)
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        Guide to submitting a request for Ireland to act as RMS in a decentralised procedure for a human medicinal product

        Irish Medicines Board (IMB) (Irish Medicines Board (IMB), 2010-08)
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        Guide to the completion of the hospital blood bank annual report: completion due 31 January 2011

        Irish Medicines Board (IMB) (Irish Medicines Board (IMB), 2011-12-21)
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        Guide to the in-vitro diagnostic medical devices legislation

        Irish Medicines Board (IMB) (Irish Medicines Board (IMB), 2010-04-06)
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