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How to show the MHRA you're meeting good clinical practice (GCP) standards and what to expect from an inspection.
Since, April 2024, the MHRA has been using Lorenz DocuBridge for eCTD management in product licence submissions. This change is part of the modernisation of the MHRA’s Legacy Systems and is one of the initial tools launched in the RegulatoryConnect...
Find out how to make sure that data entered into the Customs Declaration Service (CDS) is matched correctly with the Border Trade Matching Service (BTMS), formerly Automatic Licence Verification System (ALVS).
Guidance and information about high consequence infectious diseases and their management in England.
Directory of current ICH Guidelines which have been implemented by the Medicines and Healthcare products Regulatory Agency.
Find out details of the procedure codes and additional procedure codes that are excluded from use with Simplified Declaration Procedure (SDP) with regular use and Entry in Declarants Records (EIDR).
Guidance for industry on flexible approaches to regulation we are taking during the COVID-19 outbreak.
Listing of countries with a known occurrence of high consequence infectious disease (HCID).
This document explains the quality assurance support service for Down’s syndrome, Edwards’ syndrome and Patau’s syndrome screening (DQASS).
Advice and guidance on the health needs of migrant patients from Democratic Republic of Congo for healthcare practitioners.
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