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Home Guideline News

HPRA, Ireland publishes guidance for Withdrawal of Authorisations

PRN by PRN
April 16, 2021
in Guideline News
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HPRA, Ireland publishes guidance for Withdrawal of Authorisations
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Health Products Regulatory Authority of Ireland published “Guide to Withdrawal of Authorisations or Certificates for Human Medicines”

This guide applies to the withdrawal by the holder of an authorisation for a medicinal product, a certificate of registration for a homeopathic medicinal product or a certificate of traditional-use registration for a herbal medicinal product.

Guide can be found at below link

http://www.hpra.ie/docs/default-source/publications-forms/guidance-documents/aut-g0020-guide-to-withdrawal-of-authorisations-or-certificates-for-human-medicines-v4.pdf?sfvrsn=15

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