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 Based Exp ...



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

Coronavirus. COVID-19. 3D Render


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  ...

Two arrows textured with British and European Union flags pointing the same direction on black and white chessboard. Politics and strategic partnership concept. Horizontal composition with selective focus and copy space.


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 provide ...