WebFeb 14, 2024 · [email protected] Regulatory information service (RIS) RIS acts as the single main point of contact for marketing authorisation holders of medicines and their representatives.... WebOct 30, 2014 · Submit a new application to ARSAC Follow these steps to submit your application on the ARSAC online portal: Create a preliminary research assessment ( PRA) form on the Integrated Research...
Clinical trials for medicines: apply for authorisation in the UK
WebIRAS is a single system for applying for the permissions and approvals for health and social care / community care research in the UK and such acts as a repository for all the information required for the relevant approvals from the following bodies: Administration of Radioactive Substances Advisory Committee (ARSAC) WebFeb 15, 2024 · Last updated on 15 Feb 2024 HRA-ISRCTN Registry partnership - questions and answers Contents What’s changed? Why is HRA registering clinical trials? Why has HRA partnered with ISRCTN Registry? Why registration on either ClinicalTrials.gov or ISRCTN Registry? Can I use a different registry? Why don’t you use the EU registry? how does a vcard work
Submitting via MHRA Submissions portal - GOV.UK
WebOct 18, 2024 · Substantial Amendment Notification Form (01-Oct-2024) MHRA (Change of Sponsor): MHRA Approval (24-Apr-2024) MHRA Cover Letter (11-Apr-2024) Substantial Amendment Notification Form (05-Mar-2024) MHRA (RSI update): HRA Approval (14-Feb-2024) MHRA Approval (04-Nov-2024) MHRA Cover Letter - Clarification Post-Submission … WebGuidance on preparing an application to MHRA Medicines for a Clinical Trial Authorisation using IRAS IMPORTANT: Clinical Trials of Investigational Medicinal Products (CTIMPs) and Combined trials of an investigational medicinal product and an investigational medical … WebApr 13, 2024 · The proposed hub and spoke agreement (as subcontract) and the unmodified model agreement (as contract) should be provided in the IRAS/amendment submission, … how does a vcr work