Yes. Theanalytical requirements should be agreed with MHRA Clinical Trials via theclinical trial application (CTA). If an activity defined as manufacture takesplace (see above) then the resultant IMPs should be tested to confirm that thespecification submitted in the CTA is met. There may be exc...
very soon. This increase in the vaccine supply will in turn allow a much higher rate of vaccine deployment across the UK to all parts of the country. And this is good news for all of us at a very critical time in this
2001 EUClinicalTrialDirective:Directive2001/20/EC 2004 MedicinesforHumanUse(ClinicalTrials) Regulations2004(SI:1031) 2005 EUDirectiveonGoodClinicalPractice2005/28/EC 2006 TheMedicinesforHumanUse(ClinicalTrials) AmendmentRegulations2006(SI:1928) 2006 TheMedicinesforHumanUse(ClinicalTrials) Amendment(No.2)Regu...