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GMP

Adoption and Entry into Force of New PIC/S Guidance Documents (PI 052-1 and PI 053-1)Geneva, 1 June 2020:  The following new PIC/S guidance documents have been successfully adopted: PI 052-1 Aide-memoire - Inspection of Health Base ...

warehouse

GDP

HPRA issued updated guidance documents in September 2020http://www.hpra.ie/docs/default-source/publications-forms/guidance-documents/ia-g0046-guide-to-good-distribution-practice-of-medicinal-products-for-human-use-v5.pdf?sfvrsn=34

World map with logistic network distribution on background. Logistic and transport concept in front Logistics Industrial Container Cargo freight ship for Concept of fast or instant shipping, Online goods orders worldwide

Aviation Security

AVIATION SECURITY REGULATORY CHARGING REGIME - ADVANCE NOTICE TO REGULATED ENTITIESIn 2016, the Department of Transport, Tourism and Sport undertook a public consultation concerning the legislation to establish an aviation security regulatory ch ...

Coronavirus. COVID-19. 3D Render

COVID-19

Regulatory expectations during COVID-19 pandemicGuidance is available for marketing authorisation holders, manufacturers and importers of human and veterinary medicines on adaptations to the regulatory framework to address challenges of the ...

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BREXIT

Brexit and the Regulation of Health Products – Latest InformationThe United Kingdom left the European Union on 1 February 2020 after both sides concluded a Withdrawal Agreement to facilitate an orderly departure. The Withdrawal Agreement also pr ...