Cabinet Regulation No 289, Riga 23 March 2010 "Regulations on Conducting Clinical Trials and Non-interventional studies and Labelling of Investigational Medicinal Products, and Procedure for Conducting Inspections on Compliance with the Requirements of Good Clinical Practice"

1. Clinical trials related European directives (also in Latvian), guidelines, application forms, „Q&A document” and other relevant information can be found on: http://eudract.ema.europa.eu > Access to EudraCT Supporting Documentation > EudraLex Volume 10

2. Information about the activities of the Clinical Trial Facilitation Group (CTFG) established by EU Heads of Medicines Agencies and Voluntary Harmonization Procedure (VHP) for assessment of multicentre clinical trials can be found on: http://www.hma.eu > Human medicines > Heads of Agencies > Working groups > Clinical Trials Facilitation Group > Guidance document for a Voluntary Harmonisation Procedure (VHP) for the assessment of multinational Clinical Trial Applications