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 ...
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
Temperature and RH Mapping
Temperature mapping – an introduction.Posted by:Steve Todd, Posted on:14 July 2016 - Categories:Compliance matters, Good distribution practiceGDP Guidelines Chapter 3.2.1“An initial temperature mapping exercise should ...
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 ...
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 ...
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 ...