RAC Pharmaceuticals EU Regulations Questions and Answers

ADR - ANSWER-Adverse Drug Reaction AESGP - ANSWER-Association of the European Self-medication Industry AIFA - ANSWER-Italian Medicines Agency ATMP - ANSWER-Advanced Therapy Medicinal Products CA - ANSWER-Competent Authority CAT - ANSWER-Committee on Advanced Therapies CD-P-PH/ PHO - ANSWER-European Committee on Pharmaceuticals and Pharmaceutical Care CEN - ANSWER-European Committee for Standardization CHMP - ANSWER-Committee for Medicinal Products for Human Use CMD(h) - ANSWER-Coordination Group for Mutual Recognition and Decentralised Procedures for human medicines CMS - ANSWER-Concerned Member State COMP - ANSWER-Committee on Orphan Medicinal Products CP - ANSWER-Centralized Procedure CTA - ANSWER-Clinical Trial Application CTD - ANSWER-Common Technical Document CTFG - ANSWER-Clinical Trials Facilitation Group CVMP - ANSWER-Committee for Veterinary Medicinal Products DAR - ANSWER-Draft Assessment Report DCP - ANSWER-Decentralized Procedure DG - ANSWER-Directorate Generals